Presentation of pertinent data by one with special skill or knowledge representing mastery of a particular subject.
Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.
An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)
An advisory group composed primarily of staff physicians and the pharmacist which serves as the communication link between the medical staff and the pharmacy department.
Laws concerned with manufacturing, dispensing, and marketing of drugs.
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
Therapy for the insufficient cleansing of the BLOOD by the kidneys based on dialysis and including hemodialysis, PERITONEAL DIALYSIS, and HEMODIAFILTRATION.
Statements of goals for the delivery of health services pertaining to the Health Systems Agency service area, established under PL 93-641, and consistent with national guidelines for health planning.
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)
Pathological processes of the KIDNEY or its component tissues.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
The study of the physical and chemical properties of a drug and its dosage form as related to the onset, duration, and intensity of its action.
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS.
A common inhabitant of the colon flora in human infants and sometimes in adults. It produces a toxin that causes pseudomembranous enterocolitis (ENTEROCOLITIS, PSEUDOMEMBRANOUS) in patients receiving antibiotic therapy.
Single or multi-sheet notices made to attract attention to events, activities, causes, goods, or services. They are for display, usually in a public place and are chiefly pictorial.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
Substances that reduce the growth or reproduction of BACTERIA.
Infections with bacteria of the genus CLOSTRIDIUM.
A genus of motile or nonmotile gram-positive bacteria of the family Clostridiaceae. Many species have been identified with some being pathogenic. They occur in water, soil, and in the intestinal tract of humans and lower animals.
An acute inflammation of the INTESTINAL MUCOSA that is characterized by the presence of pseudomembranes or plaques in the SMALL INTESTINE (pseudomembranous enteritis) and the LARGE INTESTINE (pseudomembranous colitis). It is commonly associated with antibiotic therapy and CLOSTRIDIUM DIFFICILE colonization.

Novelties in the field of anti-infectives in 1998. (1/348)

In 1998, about 30 new medicinal chemical entities in the field of antibacterials and antifungals were presented during the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, held in San Diego. Among these compounds, only a few of them seem to be candidates for preclinical and clinical development: GAR 936, RWJ 54,418, ME 1209, L-084, FK 483, and DC 756. Other compounds seem to be in the preselection stage or potential lead compounds.  (+info)

Clinical strategy for the development of angiogenesis inhibitors. (2/348)

Angiogenesis inhibitors differ from conventional cytotoxic chemotherapy agents by targeting normal cells rather than tumor cells, which may contain multiple mutations. Because of this, the traditional strategy used in clinical development of cytotoxic agents may not be appropriate for these novel agents. Many clinical studies are now evaluating these agents with a new approach, referred to as the cytostatic paradigm. The cornerstone of the cytostatic paradigm is the use of time to progression (TTP) of disease as the decision-making criterion for "go/no go" in the early phases of clinical development. However, the use of TTP as the main criterion for clinical trials is complicated for a variety of reasons, including: A) the lack of standardized criteria accepted by regulatory authorities; B) the heterogeneity of the historical database, and C) the larger number of patients needed for the "go/no go" decision-making process. In addition, clinical trials of cytotoxic agents have traditionally used objective response (despite the controversy regarding objective response as a surrogate for clinical activity) as the main criterion for determining whether the results of phase II studies justify the pivotal phase III studies. Another aspect of the clinical development strategy is combining angiogenesis inhibitors with cytotoxic chemotherapy. The rationale for combination of angiogenesis inhibitors with cytotoxic agents is based on: A) different targets for these agents; B) lack of cross-resistance patterns; C) lack of myelosuppression with angiogenesis inhibitors allows administration of full doses of all agents, and D) the assumption that combining these agents will result in additive antitumor activity. Combination therapy with angiogenesis inhibitors may be attractive to both clinicians and their patients because it allows cytostatic agents to be used upfront in treatment while contributing to drug registration strategy (cytostatic/cytotoxic combination therapy versus cytotoxic therapy). The clinical development of the angiogenesis inhibitor SU5416, a small molecule inhibitor of vascular endothelial growth factor, is currently ongoing. In phase I trials, SU5416 demonstrated activity in both colorectal and non-small-cell lung cancer patients. Based on these encouraging results, phase III studies to evaluate combination of SU5416 with established cytotoxic therapy are planned. These studies will include an interim analysis, the equivalent of a phase II evaluation of clinical activity. If successful, this strategic approach will save significant time in the clinical development process.  (+info)

Bioassays of shortened duration for drugs: statistical implications. (3/348)

Declining survival rates in rodent carcinogenesis bioassays have raised a concern that continuing the practice of terminating such studies at 24 months could result in too few live animals at termination for adequate pathological evaluation. One option for ensuring sufficient numbers of animals at the terminal sacrifice is to shorten the duration of the bioassay, but this approach is accompanied by a reduction in statistical power for detecting carcinogenic potential. The present study was conducted to evaluate the loss of power associated with early termination. Data from drug studies in rats were used to formulate biologically based dose-response models of carcinogenesis using the 2-stage clonal expansion model as a context. These dose-response models, which were chosen to represent 6 variations of the initiation-promotion-completion cancer model, were employed to generate a large number of representative bioassay data sets using Monte Carlo simulation techniques. For a variety of tumor dose-response trends, tumor lethality, and competing risk-survival rates, the power of age-adjusted statistical tests to assess the significance of carcinogenic potential was evaluated at 18 and 21 months, and compared to the power at the normal 24-month stopping time. The results showed that stopping at 18 months would reduce power to an unacceptable level for all 6 submodels of the 2-stage clonal expansion model, with the pure-promoter and pure-completer models being most adversely affected. For the 21-month stopping time, the results showed that, unless pure promotion can be ruled out a priori as a potential carcinogenic mode of action, the loss of power is too great to warrant early stopping.  (+info)

Novelties in the field of anti-infective compounds in 1999. (4/348)

In 1999 the number of new compounds reported in the anti-infective field decreased significantly in comparison with previous years, especially for antifungals. The reported new compounds are mainly directed against Staphylococcus aureus isolates resistant to methicillin. Few derivatives were reported in the field of anti-infectives for gram-negative bacteria. At the moment, we are in a period of discovery as we await novel compounds that could issue from new engineering.  (+info)

Development of matrix metalloproteinase inhibitors in cancer therapy. (5/348)

The matrix metalloproteinases (MMPs) are a family of zinc-dependent proteinases involved in the degradation of the extracellular matrix. The MMPs have been implicated in the processes of tumor growth, invasion, and metastasis; are frequently overexpressed in malignant tumors; and have been associated with an aggressive malignant phenotype and adverse prognosis in patients with cancer. A number of MMP inhibitors are being developed for the treatment of cancer. The most extensively studied class of MMP inhibitors includes collagen peptidomimetics and nonpeptidomimetic inhibitors of the MMP active site, tetracycline derivatives, and bisphosphonates. The hydroxamate peptidomimetic inhibitor batimastat and its orally bioavailable analogue marimastat, which bind covalently to the zinc atom at the MMP-active site, were the first MMP inhibitors to be studied in detail. Marimastat is currently being studied in randomized clinical trials. The nonpeptidic MMP inhibitors were synthesized in an attempt to improve the oral bioavailability and pharmaceutical properties of the peptidic inhibitors. Several members of this class of compounds are undergoing evaluation in phase III clinical trials. The tetracyclines and, particularly, the nonantibiotic chemically modified tetracyclines, interfere with several aspects of MMP expression and activation and inhibit tumor growth and metastases in preclinical models. A representative agent of this class, Col-3, is currently undergoing phase I clinical trials. The development of the MMP inhibitors, like that of other targeted and predominantly antiproliferative compounds, poses a challenge because the paradigms that have governed the design of clinical oncology trials may not be relevant to this new class of agents. The anticipated need for long-term administration of these drugs, together with their cytostatic mechanism of action, will require novel clinical trial design strategies.  (+info)

From anatomy to the target: contributions of magnetic resonance imaging to preclinical pharmaceutical research. (6/348)

In recent years, in vivo magnetic resonance (MR) methods have become established tools in the drug discovery and development process. In this article, the role of MR imaging (MRI) in the preclinical evaluation of drugs in animal models of diseases is illustrated on the basis of selected examples. The individual sections are devoted to applications of anatomic, physiologic, and "molecular" imaging providing, respectively, structural-morphological, functional, and target-specific information. The impact of these developments upon clinical drug evaluation is also briefly addressed. The main advantages of MRI are versatility, allowing a comprehensive characterization of a disease state and of the corresponding drug intervention; high spatial resolution; and noninvasiveness, enabling repeated measurements. Successful applications in drug discovery exploit one or several of these aspects. Additionally, MRI is contributing to strengthen the link between preclinical and clinical drug research.  (+info)

A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. (7/348)

Standard therapy in the United States for malignancy-associated hyperuricemia consists of hydration, alkalinization, and allopurinol. Urate oxidase catalyzes the enzymatic oxidation of uric acid to a 5 times increased urine soluble product, allantoin. Rasburicase is a new recombinant form of urate oxidase available for clinical evaluation. This multicenter randomized trial compared allopurinol to rasburicase in pediatric patients with leukemia or lymphoma at high risk for tumor lysis. Patients received the assigned uric acid-lowering agent for 5 to 7 days during induction chemotherapy. The primary efficacy end point was to compare the area under the serial plasma uric acid concentration curves during the first 96 hours of therapy (AUC(0-96)). Fifty-two patients were randomized at 6 sites. In an intent-to-treat analysis, the mean uric acid AUC(0-96) was 128 +/- 70 mg/dL.hour for the rasburicase group and 329 +/- 129 mg/dL.hour for the allopurinol group (P <.0001). The rasburicase versus allopurinol group experienced a 2.6-fold (95% CI: 2.0-3.4) less exposure to uric acid. Four hours after the first dose, patients randomized to rasburicase compared to allopurinol achieved an 86% versus 12% reduction (P <.0001) of initial plasma uric acid levels. No antirasburicase antibodies were detected at day 14. This randomized study demonstrated more rapid control and lower levels of plasma uric acid in patients at high risk for tumor lysis who received rasburicase compared to allopurinol. For pediatric patients with advanced stage lymphoma or high tumor burden leukemia, rasburicase is a safe and effective alternative to allopurinol during initial chemotherapy.  (+info)

Developmental therapeutics program at the NCI: molecular target and drug discovery process. (8/348)

As the drug discovery and developmental arm of the National Cancer Institute (NCI), the Developmental Therapeutics Program (DTP) plans, conducts and facilitates development of therapeutic agents for cancer and AIDS. DTP's goal is to turn 'molecules into medicine for the public health'. Areas of support by DTP are discovery, development and pathways to development for the intramural and the extramural community. The Developmental Therapeutics Program (DTP) operates a repository of synthetic and pure natural products, which are evaluated as potential anticancer agents. The repository derives from a historical database of greater than 600 000 compounds, which have been supplied to DTP from a variety of sources worldwide. The in vitro anti-cancer drug cell line screen established at DTP is unique in several respects. It has changed the NCI emphasis from a compound-oriented drug discovery effort to a disease-panel oriented exercise, emphasized human tumor cells derived from solid tumors, developed a high volume screening method that can adapt to processing of numerous chemical agents or natural source-derived extracts, that has minimized the use of animals, and saved on the amount of material required for the initial screening. The hollow fiber assay created at the DTP has demonstrated the ability to provide quantitative initial indices of in vivo drug efficacy, with minimum expenditures of time and materials and is currently being utilized as the initial in vivo experience for agents found to have reproducible activity in the in vitroanticancer drug screen. Drugs showing activity with unique mechanisms of actions are being further developed for treatment of hematopoietic neoplasms, prominent examples being flavopiridol, UCN-01 and depsipeptide among others.  (+info)

For females, who have agreed with contraception from start of investigational drug administration to 5 months after last dose of investigational drug. For males who have agreed with contraception from start of investigational drug administration to 7 months after last dose of investigational drug ...
Takedas New Investigational Drug Vedolizumab Entered Phase 3 Clinical Trials in Japan for the Treatment of Ulcerative Colitis and Crohns Disease
New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint
Study information from Be Involved at Wake Forest Baptist Medical Center for: A Study to Evaluate How Well Certain Types of Cancer Respond to an Investigational Drug (LOXO-101)
The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study ...
A new investigational drug has demonstrated high response rates in patients with a rare but highly aggressive blood disease that currently has no approved therapies, according to new research led by investigators at The University of Texas MD Anderson Cancer Center.
Merck and Bayers Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure
GMP clinical trial material manufacturing services to meet your supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials around the world Clinical trial materials manufacturing, to meet the supply needs of Phase I and II pharmaceutical clinical trials, requires a flexible and consistent contract services partner. Whilst sourcing high-quality supplies within trial timelines, you will need clinical trial supply manufacturing that is both fully GMP compliant and responsive.. Our clinical trial supplies manufacturing services are delivered from our state-of-the-art Good Manufacturing Practice (GMP) compliant facilities supporting investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials around the world ...
The Food and Drug Administrations expanded access program, which is intended to provide access to unapproved drugs for patients with a life-threatening illness and no available treatment, does not require that drug companies provide these drugs.
In a first-time disclosure of IPN60090, a small-molecule inhibitor of the metabolic enzyme glutaminase (GLS1), researchers from The University of Texas MD Anderson Cancer Centers Therapeutics Discovery division and Ipsen Biopharmaceuticals reported the preclinical discovery and early-stage clinical development of this novel drug. IPN60090, now under investigation in a Phase I trial, may hold benefit for certain patients with lung and ovarian cancers.
In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application. The NDA is supported by data from both the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE). The FDA granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. Plazomicin has also received Qualified Infectious Disease Product (QIDP) designation from the FDA which provides incentives for the development of new antibiotics, including priority ...
May 11, 2016 - Santen Europe (Geneva, Switzerland) and Santen Pharmaceutical Co., Ltd. (Osaka, Japan) have today announced that the Phase III clinical trial of its investigational drug, ciclosporin 1mg/mL eye drops, (proposed trade name Vekacia®), has met its primary and key secondary endpoints, demonstrating the investigational drugs efficacy and tolerability, versus placebo[1], in the treatment of active, severe vernal keratoconjunctivitis (VKC) in paediatric patients.[i] The trial, Vektis, was a multicentre, randomised, double blind, three parallel-arm, placebo-controlled study in patients aged 4-18 years.. VKC is a severe and recurrent allergic eye condition that mainly affects children (predominantly boys) and young adults, and which results in intense itching photophobia, painful eyes, and potentially even permanent loss of vision.[ii] The condition is characterised by severe inflammation of the ocular surface, including the conjunctivae and cornea (keratitis). Currently available ...
This trial is the first to study Optune in combination with an investigational drug ST. HELIER, Jersey-(BUSINESS WIRE)- Novocure (NASDAQ:NVCR) announced today a new arm for a phase 1b study to evaluate the safety of marizomib and temozolomide in combination with Optune, Novocures Tumor Treating Fields (TTFields) delivery system, as adjuvant treatment for patients with newly diagnosed glioblastoma (GBM) following radiation therapy with concurrent temozolomide. The trial is the first to study Optune in combination with an investigational drug. Marizomib is a novel, brain-penetrant proteasome inhibitor developed by Triphase Accelerator Corporation and acquired by Celgene Corporation. Celgene is responsible for marizomibs development. This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM, said Principal Investigator Dr. Roger Stupp, Associate Director for Strategic Initiatives at the Robert H. Lurie ...
The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the safety and tolerability of DFMO in combination with bortezomib as well as the tumors response to this study drug.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice. ...
BARCELONA Spain--(BUSINESS WIRE)--Apr 14 2007 - In a late-breakerpr... The high rates of RVR observed in the telaprevir groups inPROVE 1 a...PROVE 1 Summary ...-- 88% and 79% of patients receiving telaprevir achieved a rapidviral...,Interim,Results,Presented,at,EASL,from,PROVE,1,Clinical,Trial,of,Investigational,Drug,Telaprevir,in,Patients,with,Genotype,1,Hepatitis,C,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice. ...
This study is currently recruiting participants. Verified July 2012 by Astellas Pharma Inc First Received on January 25, 2011. Last Up…
Worldwide pivotal phase III study in women with recurrent ovarian cancer underway SYDNEY, Australia and WASHINGTON, May 01, 2007 A new study further supports th
Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her ...
The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to suppo
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against tumor cells. The effectiveness of nivolumab in glioblastoma (GBM or brain cancer) will be determined by comparing the survival of subjects who receive the investigational drug nivolumab combined with radiotherapy to those who receive temozolomide with radiotherapy, an accepted therapy for newly diagnosed GBM.. If you agree to be in this study, a biopsy of your tumor will tested for a specific gene. If you have that gene, you will be eligible to participate in the study. In addition to taking either nivolumab or temozolomide in combination with radiotherapy you will be asked to complete other study procedures. Those study procedures may include physical exams, medical history, blood ...
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), the most common form of head and neck cancer, may benefit from
CAMBRIDGE, MASSACHUSETTS--(Marketwired - Aug. 15, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV) (TSX:VBV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug Application (IND) for VBI-1901, a novel immunotherapy targeting Glioblastoma...
BioSig Subsidiary ViralClear Submits Investigational New Drug Application to the FDA for Phase II Clinical Trials for Merimepodib, an Orally Administered Treatment for Patients with COVID-19 - read this article along with other careers information, tips and advice on BioSpace
GTX-102 for Angelman syndrome is cleared for clinical trials following the FDAs activation of its investigational new drug application.
Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for OCU310 (brimonidine/steroid combination therapy), a topical formulation for the treatment of dry eye disease (DED). In addition, the Company announced that its first patient was dosed in a proof of concept study. This randomized, placebo-controlled, double-blind, multi-center, proof of concept study will assess the tolerability and preliminary efficacy of OCU310 for the treatment of DED.. We are very excited to begin our first clinical study and dose our first patient, said Daniel Jorgensen, MD, Chief Medical Officer at Ocugen. Our goal is to assess whether a combination product has potential benefit, in treating dry eye patients, while exploring the most appropriate endpoints for future pivotal studies.. This is an important milestone for Ocugen as we ...
COPENHAGEN, Denmark, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon(TM) technologies to create product candidates that address unmet medical needs, today announced the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration to initiate the clinical program of TransCon TLR7/8 Agonist. TransCon TLR7/8 Agonist is a long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLR) 7 and 8. Administered as an intratumoral injection, TransCon TLR7/8 Agonist is designed to provide sustained activation of intratumoral antigen presenting cells driving tumor antigen presentation and induction of immune stimulatory cytokines in the tumor. The filing of our first oncology IND for TransCon TLR7/8 Agonist -- which is designed to provide intratumoral, sustained release of resiquimod over several weeks from a single administration with minimal systemic ...
NEWARK, Calif., June 3, 2015 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (Nasdaq:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced its plans to move forward with two key clinical studies for its investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A.
OXFORD, UK / ACCESSWIRE / March 13, 2019 / IntraBio Inc., a late-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA)
DURHAM, N.C., Oct. 6, 2014-- Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease. Chimerix is committed to working with global health organizations and government agencies in the fight against...
Certain statements set forth in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the timing of filing of clinical trial applications and INDs, the Companys ability to address questions raised by the regulators satisfactorily in connection with its clinical trial applications (CTAs) and INDs, the Companys ability to obtain regulatory approval(s) of its CTAs and/or its INDs, the timing of commencement of clinical trials, the intellectual property coverage and positions of the Company, its licensors and third parties, the sufficiency of the Companys cash resources and the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. You are cautioned that forward-looking statements are inherently uncertain. Although the Company believes that such statements are based on reasonable assumptions ...
Certain statements set forth in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the timing of filing of clinical trial applications and INDs, any approvals thereof and timing of commencement of clinical trials, the intellectual property coverage and positions of CRISPR Therapeutics, its licensors and third parties, the sufficiency of CRISPR Therapeutics cash resources and the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of ...
... PRINCETON N.J. June 1 2015 /...In February 2015 Advaxis and Incyte entered into a non-exclusive clin... The FDA clearance of the ADXS-HPV plus epacadostat IND for HPV-associ...,Advaxis,Announces,FDA,Clearance,of,Investigational,New,Drug,Application,for,Phase,2,Study,of,ADXS-HPV,and,Incytes,epacadostat,for,the,Treatment,of,HPV-Associated,Early,Stage,Cervical,Cancer,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
TY - JOUR. T1 - Targeting Aurora A kinase activity with the investigational agent alisertib increases the efficacy of cytarabine through a FOXO-dependent mechanism. AU - Kelly, Kevin R.. AU - Nawrocki, Steffan T.. AU - Espitia, Claudia M.. AU - Zhang, Mengkun. AU - Yang, Johnny J.. AU - Padmanabhan, Swaminathan. AU - Ecsedy, Jeffrey. AU - Giles, Francis J.. AU - Carew, Jennifer S.. N1 - Copyright: Copyright 2013 Elsevier B.V., All rights reserved.. PY - 2012/12/1. Y1 - 2012/12/1. N2 - Novel therapies are urgently needed to improve clinical outcomes for patients with acute myeloid leukemia (AML). The investigational drug alisertib (MLN8237) is a novel Aurora A kinase inhibitor being studied in multiple Phase I and II studies. We investigated the preclinical efficacy and pharmacodynamics of alisertib in AML cell lines, primary AML cells and mouse models of AML. Here, we report that alisertib disrupted cell viability, diminished clonogenic survival, induced expression of the FOXO3a targets p27 and ...
This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. The final rule lays out clear definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information ...
SAN DIEGO, Nov. 17, 2015 /PRNewswire/ -- Viking Therapeutics Submits Investigational New Drug (IND) Application to Conduct Phase 2 Clinical Trial of VK2809...
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.. Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).. For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide those ...
ATLANTA, May 13, 2011 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq:ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the resubmission on May 12, 2011 of its New Drug Application for the investigational drug ILUVIEN® to the U.S. Food and Drug Administration (FDA). The resubmission addresses questions raised in the Complete Response Letter (CRL) received in December 2010.
Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients. We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients, said Dr. Mark J. Murray Tekmiras President and CEO.. We have insisted on acting responsibly in the interest of patients and our stakeholders, added Dr. Murray. Today we are reporting that, working closely with regulators in the United States and Canada, we have established a framework for TKM-Ebola use in multiple patients. In the US, the FDA has granted expanded access use of TKM-Ebola under our Investigational New Drug application (IND) and Health Canada has established a similar framework, both of which allow the use of our investigational therapeutic in more patients.. We have already responded to requests for the use of our investigational agent in several patients under emergency protocols, in an ...
The investigational drug cabozantinib is showing promise in the treatment of metastatic, hormone-refractory prostate cancer, with particularly notable results among patients with bone metastases. These results were presented at the 2011 annual meeting of the American Society of Clinical Oncology.. Prostate cancer is a hormonally sensitive disease that can be controlled for long periods with androgen deprivation therapy (ADT). When prostate cancer stops responding to this treatment is it referred to as hormone-refractory prostate cancer. Advances have been made in the treatment of hormone-refractory cancer, but challenges remain and new drugs continue to be developed.. Cabozantinib is an investigational drug that targets two proteins-MET and VEGFR2-that play a role in the development and progression of many types of cancer.. To evaluate cabozantinib in the treatment of hormone-refractory, metastatic prostate cancer, researchers conducted a Phase II clinical trial among 171 patients with ...
Bayer has scored a US Food and Drug Administration (FDA) priority review for its investigational drug finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone - also known as BAY 94-8862 - is a selective mineralocorticoid receptor antagonist (MRA). Overactivation of the mineralocorticoid receptor is believed to play a key role in kidney and cardiovascular damage, through inflammatory and fibrotic processes.. The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D. The participants were randomly assigned in a 1:1 ratio to receive either Bayers investigational drug or a placebo.. In this trial, patients with CKD and T2D who received finerenone treatment experienced lower risks of CKD progression and cardiovascular events compared to placebo.. On the primary endpoint of kidney failure outcomes, patients treated with finerenone an 18% relative risk reduction compared to the placebo ...
From BioPortfolio: WALTHAM, Mass., Aug. 12, 2015 (GLOBE NEWSWIRE) -- Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address th...
In collaboration with Global Blood Therapeutics, our folks here at XVIVO created this medical animation to illustrate the mechanism of action of a potential drug candidate for the treatment of sickle cell disease (SCD). SCD is caused by a point mutation in the hemoglobin gene, resulting in the aggregation and polymerization of deoxygenated hemoglobin. This causes structural deformation of red blood cells into the characteristic sickle shape, which can lead to cellular lysis and vaso-occlusion, impairing oxygen delivery and causing a number of health effects. GBT440 is an investigational disease-modifying drug that binds to hemoglobin and increases its affinity to oxygen, keeping it in its oxygenated state. By diluting the concentration of deoxygenated hemoglobin, mutant hemoglobin may be kept from polymerizing, thus preventing cellular sickling and its many clinical consequences.. ...
Update (April 15, 2014): This story has been updated to reflect that there is now a new FDA office, the Office of Health and Constituent Affairs, whose job it is to serve as a liaison between the FDA and various outside stakeholders, including patient advocates and consumers. See Resources, below. ===================================================================================== Original... ...
SOUTH SAN FRANCISCO, Calif., July 24, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the publication of a peer-reviewed paper in the August 2012 issue of
I am writing this blog to share the knowledge/views, after reading Scientific Journals/Articles/News Articles/Wikipedia. My views/comments are based on the results /conclusions by the authors(researchers). I do mention either the link or reference of the article(s) in my blog and hope those interested can read for details. I am briefly summarising the remarks or conclusions of the authors (researchers). If one believe that their intellectual property right is infringed by any content on this blog, please contact or leave message at below email address.. It will be removed ASAP ...
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) amendment to evaluate PROHEMA® in pediatric patients undergoing hematopoietic stem cell (HSC) transplantation for the treatment of hematologic malignancies. The FDAs clearance of the IND amendment allows the Company to expand its clinical investigation of PROHEMA®, which to date has only been administered to adults, in pediatric patients as young as one year of age. The Company plans to initiate enrollment of the PROMPT (PROHEMA® for the treatment of hematologic Malignancies in PediaTric patients undergoing single umbilical cord blood transplantation) study, which is designed to enroll up to 18 patients, between the ages of 1 and 18, at three leading U.S. pediatric transplant centers in mid-2014.. Each year, over 3,500 ...
HOUSTON, TX -- (Marketwired) -- 11/14/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its financial results for the third quarter ended September 30, 2017. Additionally, the Company announced potential upcoming milestones and recent corporate developments.. Management Discussion Walter Klemp, Chairman and CEO of Moleculin, commented, We continue to make progress in advancing our drug candidates through their various regulatory approval pathways. We accomplished a number of important milestones on Annamycin, one of our lead cancer drug candidates. During the quarter, the Food and Drug Administration (FDA) allowed our Investigational New Drug application (IND) to proceed, meaning we could begin clinical trials of Annamycin ...
Zurich-Schlieren, May 30, 2017. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced that the first patient was dosed in the phase 2 multiple myeloma study of its lead oncology asset MP0250. In the first phase 2 study, the efficacy and safety of MP0250 will be examined in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The study will be performed in three different countries: Germany, Poland and Italy. Initial safety data are expected in 2017 and efficacy data in 2018.. In addition, the company announced that MP0250 will also be further evaluated in solid tumors. Molecular Partners intends submit to the FDA in H2 2017 an Investigational New Drug Application (IND) for a phase 1b/2 trial of MP0250 in combination with osimertinib (Tagrisso®) in EGFR-mutated T790M-positive Non-Small Cell Lung Cancer (NSCLC) patients. ...
Arrowhead Research Corporation announced today that its majority owned subsidiary, Calando Pharmaceuticals, a leading siRNA therapeutics company, submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration to initiate a Phase I clinical trial using their lead anti-cancer compound, CALAA-01.
Genocea is a biopharmaceutical company developing personalized cancer immunotherapies. Our unique ATLAS™ technology platform allows us to identify immunotherapy targets based on each persons tumor antigen-specific T cell responses. Using ATLAS, we can both optimize neoantigens for inclusion in our immunotherapies and exclude so-called inhibitory antigens that appear to exert an immunosuppressive effect on the patient. We are advancing complementary programs built from ATLAS insights: GEN-009, our neoantigen vaccine candidate for which we are conducting a Phase 1/2a clinical trial across a variety of solid tumor types, and GEN-011, our neoantigen-specific adoptive T cell therapy, for which we intend to file an Investigational New Drug Application in the first half of 2020. To learn more, please visit www.genocea.com. Forward-Looking Statements ...
The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasnt until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agencys rigorous evaluation process, which scrutinizes everything about the drug-from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured. Stages of Drug Development and Review Investigational New Drug Application (IND)-The ...
As a result, the control group began to receive the combined therapy right away, and this became the new standard of treatment for pediatric neuroblastoma. Patients from the United States, Canada, Australia, and New Zealand enrolled in the trial to receive the drug, and BDP manufactured additional supplies to meet the demand. Results of the clinical trial were published in the New England Journal of Medicine [4] in September 2010.. After decades of pursuits, I am pleased to see that dinutuximab has received FDA approval and may now benefit high-risk neuroblastoma patients, Yu said in a news release from United Therapeutics Corporation, which will manufacture and market the drug under the brand name UnituxinTM.. This is not only the first successful immunotherapeutic to target a non-protein antigen, but also to be developed from an Investigational New Drug application through Phase III trials largely through investigator-initiated effort and NCI support, Yu said.. The FDA approval calls for ...
Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin),
There are distinct phases of clinical trials, time lines and protocols to be followed. Each phase is tasked with answering a specific question. Pre-clinical research is the initial phase of the clinical trial in which a doctor has a research theory which must be proved in a laboratory before he can proceed to human testing. It must be first tested in laboratory animals and proved to be effective. This stage can take years to happen. If it is successful the next step is to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for permission to study the treatment in people. The application must be approved in order to proceed to the next step. Throughout all these steps the information collected concentrates on the dose, safety and how well the treatment works.. Phase I involves a small number of participants - usually about 10-30 people- testing the treatment. All treatments that are now in clinical practice have been tested in a Phase 1 clinical ...
The FDA cleared an investigational new drug application for VOR33, an engineered stem cell therapy for the treatment of patients with acute myeloid leukemia who are at high risk for relapse, according to the agent’s manufacturer.VOR33 (Vor Biopharma) is a hematopoietic stem cell therapy that is genetically engineered to lack the CD33 protein. Removal of this protein allows for subsequent
These same prevention methods apply when living in or traveling to an area affected by an Ebola outbreak. After returning from an area affected by Ebola, monitor your health for 21 days and seek medical care immediately if you develop symptoms of EVD.. There is currently no vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect people from Ebola virus. An experimental vaccine called rVSV-ZEBOV was found to be highly protective against the virus in a trial conducted by the World Health Organization (WHO) and other international partners in Guinea in 2015. FDA licensure for the vaccine is expected in 2018. In the meantime, 300,000 doses have been committed for an emergency use stockpile under the appropriate regulatory mechanism (Investigational New Drug application [IND] or Emergency Use Authorization [EUA]) in the event an outbreak occurs before FDA approval is received. Scientists continue to study the safety of this vaccine. This vaccine has been used during Ebola outbreaks ...
Movies, Books. Timeline of Medical Biotechnology. Flu book - Typhoid Mary by Anthony Bourdain. The Andromeda Strain by Michael Crichton. Do it - competition, volunteer, games, make it, lesson plan, take action. Mission Biotech Game (NSF funded) (single player online game). Biotech Game of Life (printable board game) Key Concepts: patent, grant, clinical trials (Phase 1-Safety, Phase 2-Dosage, Phase 3-Efficacy), FDA: The Food and Drug Administration, Venture Capital, IND: - Acronym for Investigational New Drug Application, Fast tracking. Zombie Plague free software Students explore a 3D world where they are responsible for identifying the pathogenic microorganism causing a deadly outbreak and implementing a cure. Although we have chosen to have the symptoms of our fictional disease be zombieism, the science content embedded in the software deals with diagnosis, treatment strategies, and career connections that are applicable to any disease caused by viruses, bacteria or fungi. Interactions with ...
Fibrocell Science has filed an investigational new drug application with the U.S. FDA for its gene therapy candidate FCX-013 to treat moderate to severe localized scleroderma.
The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training Branch to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an Investigational New Drug Application (IND) to administer an investigational product to humans ...
San Diego-based Batu Biologics, an oncology company dedicated to the development of its clinical stage tumor-angiogenesis targeting immunotherapy, announced the successful closure of a 506(c) equity crowdfunding offering bringing in $1.3 million in capital.. The proceeds of this offering were initially earmarked for investigational new drug-enabling experiments, when the offering was launched on EquityNet in May of 2017.. In early November of this year, Batu announced the clearance of the Investigational New Drug Application for its immune therapy, ValloVax. With the successful completion of that milestone, Batu said the remaining proceeds from this offering will be used to upscale GMP (Good Manufacturing Practice) in preparation for the companys phase I study and to position it to secure partnerships to demonstrate clinical proof of concept for the ValloVax program.. ValloVax is designed to target and kill blood vessels that feed tumor growth.. According to Batu, ValloVax has demonstrated ...
HHS Secretary Tommy Thompson announced on Tuesday that FDA has authorized the use of GlaxoSmithKlines flu vaccine Fluarix under an investigational new drug application, and HHS will purchase 1.2 million doses of the vaccine.
Category 1: Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.. Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non‑pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the participants, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week ...
In the recent edition of Molecular Genetics and Metabolism, P. Dickson and J. Tolar discuss the potential of individual investigational new drug applications (iINDs) for N-of-One therapeutic trials of experimental therapies in inborn errors of metabolism (Mol Gen Metab 116 (2015):1-3). They discuss pros: faster bench to bedside translation, treating life-threatening conditions with no other therapeutic options, and cons: […]. ...
Expanded access, sometimes called compassionate use, is the use of an investigational medical product outside of a clinical trial (i.e., one that has not yet been approved). At Novelion Therapeutics, and our subsidiary Aegerion Pharmaceuticals, we are committed to increasing awareness of and knowledge about our expanded access programs and the procedures for obtaining access to human investigational drugs. A Message from John Orloff, M.D.
This milestone marks the second IND generated through our productive collaboration with Lilly, said Bob D. Brown, Ph.D., Chief Scientific Officer and Executive Vice President of R&D at Dicerna. In addition to the two candidates now at clinical stage, there are so far, nine discovery research programs connected to this alliance, emphasizing Dicernas and Lillys shared commitment to bringing forward new RNAi-based therapies to treat a broad range of diseases. The IND filing for LY3819469 is the second development milestone achieved under a 2018 global licensing and research collaboration between Dicerna and Lilly focused on the discovery, development and commercialization of potential new therapies for cardiometabolic and neurodegenerative diseases and pain. This investigational cardiometabolic therapy and future therapies to emerge from the two companies collaboration leverage Dicernas proprietary GalXC RNAi technology platform. Under the agreement, Dicerna is eligible to receive up to $350 ...
/PRNewswire/ -- StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational...
Since MK-677 is still an Investigational New Drug, it has not yet been approved to be marketed for consumption by humans in the ... An Anti-frailty Pill For Seniors? New Drug Increases Muscle Mass In Arms And Legs Of Older Adults. ScienceDaily November 5th, ... a b c d http://adisinsight.springer.com/drugs/800007434 *^ a b Patchett AA, Nargund RP, Tata JR, Chen MH, Barakat KJ, Johnston ...
US: Investigational New Drug Identifiers. IUPAC name. *(2S)-2-{(2R,3S,4R,5R)-[5-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5- ... This antiinfective drug article is a stub. You can help Wikipedia by expanding it.. *v ... Remdesivir (development code GS-5734) is an antiviral drug, a novel nucleotide analog prodrug. It was developed by Gilead ... "Experimental Ebola drug 'remdesivir' may help protect against Nipah virus, say scientists". 3 June 2019.. ...
"Investigational New Drugs. 30 (6): 2391-9. doi:10.1007/s10637-012-9818-6. PMC 3557459. PMID 22547163.. ... the 27 colorectal PDX models may be able to serve as pre-clinical models in future drug studies. Drug resistance studies have ... For drug development studies, expansion of mice after the F3 generation is often utilized after ensuring that the PDX has not ... Hutchinson L, Kirk R (April 2011). "High drug attrition rates--where are we going wrong?". Nature Reviews. Clinical Oncology ( ...
"GTx begins Phase II trial of enobosarm to treat women with stress urinary incontinence - Drug Development Technology". Drug ... List of investigational hormonal agents § Androgenics. References[edit]. *^ "Enobosarm - GTx". AdisInsight. Retrieved 25 April ... For this reason, SARMs were banned by the World Anti-Doping Agency in January 2008 despite no drugs from this class yet being ... Enobosarm, also known as ostarine, is an investigational selective androgen receptor modulator (SARM) developed by GTX, Inc for ...
This drug article relating to the genito-urinary system is a stub. You can help Wikipedia by expanding it. *v ... Andarine (GTx-007, S-4) is an investigational selective androgen receptor modulator (SARM) developed by GTX, Inc for treatment ... This antineoplastic or immunomodulatory drug article is a stub. You can help Wikipedia by expanding it. *v ... but its partial agonist effects at androgen receptors prevent the side effects associated with the anti-androgenic drugs ...
See also: List of investigational sexual dysfunction drugs. The drug is under development for the treatment of premature ... Food and Drug Administration. Retrieved July 26, 2010.. *^ Wellman-Labadie O, Zhou Y (May 2010). "The US Orphan Drug Act: rare ... "FDA Approved Drug Products - Dysport". www.accessdata.fda.gov. U.S. Food and Drug Administration. Retrieved 2016-11-07.. ... The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to ...
Investigational New Drugs. 27 (2): 159-65. doi:10.1007/s10637-008-9165-9. PMC 4171042. PMID 18712502. Henry NL, Dunn R, ... Orphan Drug Designations and Approvals: choline tetrathiomolybdate, U.S. Food and Drug Administration, 25 August 2011 Komatsu Y ... Investigational New Drugs. 31 (2): 435-42. doi:10.1007/s10637-012-9864-0. PMC 4418641. PMID 22847786. Roberts EA, Schilsky ML ( ...
Investigational New Drugs. 34 (4): 439-49. doi:10.1007/s10637-016-0348-5. PMC 4919369. PMID 27056178. Sarantopoulos J, Shapiro ... In experiments with mice, Pevonedistat, a drug inhibiting activation of NEDD8, prevented high-fat diet-induced obesity and ... a drug inhibiting activation of NEDD8, has shown a significant therapeutic effect in four Phase I clinical cancer trials in ... "A phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with ...
Investigational New Drugs. 14 (2): 161-167. doi:10.1007/BF00210787. PMID 8913837. S2CID 8439510. Wang, Y.; Wiltshire, T.; Senft ... Soon after, the drug was again sub-licensed to Oncology Venture. The drug has undergone a number of clinical trials, mostly for ... Platinum and irofulven pharmacokinetics did not suggest drug-drug interactions. Despite modest successes demonstrating limited ... Invest New Drugs. 24(4):311-9. doi:10.1007/s10637-005-5055-6. Both Danish sites now open in the Screening Study of prostate ...
Investigational New Drugs. 30 (4): 1471-83. doi:10.1007/s10637-011-9730-5. PMID 21850491. S2CID 20880580. Huot P, Johnston TH, ... Its chemical structure is very similar to that of the illegal drug MDMA, the only difference being the replacement of the α- ... MBDB Methyl-K (UWA-091) UWA-001 RTI-83 - another drug which selectively increases dopamine and serotonin levels without ... 2010). "Redesigning the designer drug ecstasy: nonpsychoactive MDMA analogues exhibiting Burkitt's lymphoma cytotoxicity". ...
Investigational New Drugs. 35 (3): 307-314. doi:10.1007/s10637-016-0422-z. PMID 28054329. S2CID 596267. Nishiyama N, Matsumura ... drug dose and drug intermediates produced. Since artefactual mechanisms of action can be observed, the following mechanisms ... A myriad of drug-cellular interactions have been documented in the scientific literature and these vary with respect to the ... Drug interactions with anthracyclines can be complex and might be due to the effect, side effects, or metabolism of the ...
Investigational New Drugs. 30 (4): 1361-70. doi:10.1007/s10637-011-9700-y. PMID 21678129. Azcárate IG, Marín-García P, Camacho ...
Investigational New Drugs. 17 (3): 313-20. doi:10.1023/a:1006353008903. PMID 10665481. S2CID 23551260. "FDA Grants Palbociclib ... Research, Center for Drug Evaluation and. "Approved Drugs - FDA approves abemaciclib for HR-positive, HER2-negative breast ... Complications of developing a CDK drug include the fact that many CDKs are not involved in the cell cycle, but other processes ... Although it was originally developed as a potential anti-cancer drug, seliciclib has also proven to induce apoptosis in ...
Investigational New Drugs. 31 (3): 760-8. doi:10.1007/s10637-012-9869-8. PMID 22907596. S2CID 29365102. "CNTO-888/Carlumab" ( ... "Carlumab". NCI Drug Dictionary. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer ... World Health Organization (2010). "Proposed International Nonproprietary Names: List 104" (PDF). WHO Drug Information. 24 (4). ... safety and dose requirements of the drug. Clinical trials for Carlumab include studies of idiopathic pulmonary fibrosis, ...
Investigational New Drugs. 33 (4): 977-84. doi:10.1007/s10637-015-0257-z. PMID 26062928. Kaufman AC, Salazar SV, Haas LT, Yang ... Expert Opinion on Investigational Drugs. 19 (8): 931-45. doi:10.1517/13543784.2010.499898. PMID 20557276. Gubens MA, Burns M, ... Saracatinib (AZD-0530) is an experimental drug being developed by AstraZeneca. It acts as a dual kinase inhibitor, with ...
1995). "Mitomycin C and menadione for the treatment of lung cancer: a phase II trial". Investigational New Drugs. 13 (2): 157- ... According to the U.S. Food and Drug Administration (FDA), high-dose vitamin C (such as intravenous ascorbic acid therapy) has ... "The Vitamin C Foundation - 514071 - 04/17/2017". U.S. Food and Drug Administration. 2019-04-23. Retrieved 2019-06-07. Hoffman ... "Cernevit™-12 (multivitamins for infusion)" (PDF). Food and Drug Administration. 1999. Jacob RA, Sotoudeh G (March 2002). " ...
List of investigational hormonal agents § Androgenics "Enzalutamide (Xtandi) Use During Pregnancy". Drugs.com. 4 September 2018 ... Jeffrey K Aronson (4 March 2014). Side Effects of Drugs Annual: A worldwide yearly survey of new data in adverse drug reactions ... Investigational New Drugs. 33 (3): 751-4. doi:10.1007/s10637-014-0193-3. PMC 4451215. PMID 25467090. McCutcheon SB (2013). " ... The drug has only 2-fold lower affinity for the AR than DHT, the endogenous ligand of the AR in the prostate gland. When LNCaP ...
Investigational New Drugs. 29 (3): 514-22. doi:10.1007/s10637-009-9361-2. PMID 20024691. S2CID 20865470. Liu, Shwu-Huey; Cheng ... As of 2019 Kadmon produces several generic drugs approved by the Food and Drug Administration in the United States. ... SLx-2101 (KD027) is a phosphodiesterase 5 (PDE5) inhibitor, a class of drug used in the treatment of erectile dysfunction. In ... Kadmon however immediately began acquiring drugs further advanced - either already marketed in the US or in the later stages of ...
Investigational New Drugs. 26 (2): 159-67. doi:10.1007/s10637-008-9112-9. PMID 18219445. S2CID 40419869. "ZD6126". ... "ZD6126". NCI Drug Dictionary. U.S. National Cancer Institute. Goto H, Yano S, Zhang H, Matsumori Y, Ogawa H, Blakey DC, Sone S ...
Investigational New Drugs. 22 (4): 411-20. doi:10.1023/B:DRUG.0000036683.10945.bb. PMID 15292711. S2CID 31613292. Gullbo, J; ... "Pepaxto: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 1 March 2021. Gullbo, J; Tullberg, M; Våbenø, ... Investigational New Drugs. 26 (3): 195-204. doi:10.1007/s10637-007-9092-1. PMID 17922077. S2CID 19915448. Chauhan, D; Ray, A; ... Investigational New Drugs. 33 (6): 1232-41. doi:10.1007/s10637-015-0299-2. PMID 26553306. S2CID 8207569. Viktorsson, K; Shah, C ...
Investigational New Drugs. 30 (4): 1289-301. doi:10.1007/s10637-011-9676-7. PMC 3203350. PMID 21547369. Jansen FH (July 2010 ... Dihydroartemisinin is used to treat malaria, generally as a combination drug with piperaquine. In a systematic review of ... "Dihydroartemisinin". Drug Information Portal. U.S. National Library of Medicine. Medicine portal. ... Dihydroartemisinin (also known as dihydroqinghaosu, artenimol or DHA) is a drug used to treat malaria. Dihydroartemisinin is ...
Investigational New Drugs. 33 (1): 201-14. doi:10.1007/s10637-014-0179-1. hdl:1874/314465. PMID 25344453. S2CID 27817700. NAMI- ... New anti-tumor metastasis inhibitor or NAMI-A is a ruthenium based anti-cancer drug and is one of two ruthenium-based drugs ... Drug was given intravenously with and without a port-a-cath. Several side effects were observed including: Mild hematologic ... Due to these results, Phase II trials, using NAMI-A as a solo drug, were not pursued. Due to negative results of the stand- ...
Investigational New Drugs. 23 (2): 147-155. doi:10.1007/s10637-005-5860-y. ISSN 0167-6997. PMID 15744591. S2CID 20979000. ... a study of the Investigational New Drug Program of the National Cancer Institute of Canada Clinical Trials Group". ...
Investigational New Drugs. 22 (1): 39-52. doi:10.1023/B:DRUG.0000006173.72210.1c. PMID 14707493. S2CID 24877721. Hofheinz RD, ...
Investigational New Drugs. 30 (6): 2391-9. doi:10.1007/s10637-012-9818-6. PMC 3557459. PMID 22547163. Jiang, Hua; et al. (8 ... Due to their stability, the 27 colorectal PDX models may be able to serve as pre-clinical models in future drug studies. Drug ... For drug development studies, expansion of mice after the F3 generation is often utilized after ensuring that the PDX has not ... Researchers are beginning to attribute the reason that only 5% of anti-cancer agents are approved by the Food and Drug ...
Investigational New Drugs. 23 (6): 577-81. doi:10.1007/s10637-005-0793-z. PMID 16034517. S2CID 33471927. Das PC, Roberts JD, ... Castanospermine Mannosidosis "NCATS Inxight: Drugs". drugs.ncats.io. Retrieved 2020-01-22. Stegelmeier BL, Molyneux RJ, Elbein ... It is a potent inhibitor of Golgi alpha-mannosidase II, an immunomodulator, and a potential chemotherapy drug. As a toxin in ... Swainsonine also has potential uses as an adjuvant for anti-cancer drugs and other therapies in use. In mice, swainsonine ...
Investigational New Drugs. 31 (4): 1044-50. doi:10.1007/s10637-013-9940-0. PMID 23435622. S2CID 21363127. Jonasch, Eric; ... a class of drugs that targets the folic acid metabolic pathway. The results of the trial showed tumors shrank in 41 percent of ...
Investigational New Drugs. 26 (2): 111-8. doi:10.1007/s10637-007-9087-y. PMID 17906845. Rosso M, Robles-Frías MJ, Coveñas R, ... L-733,060 is a drug developed by Merck which acts as an orally active, non-peptide, selective antagonist for the NK1 receptor, ...
Investigational New Drugs. 33 (2): 505-509. doi:10.1007/s10637-015-0209-7. PMC 4487887. PMID 25613083. "Long-term results of ... Mipsagargin (G-202), has orphan drug designation as a treatment during chemotherapy for HCC. It is a thapsigargin-based prodrug ... Hepcortespenlisimut-L (Hepko-V5), an oral cancer vaccine, also has US FDA orphan drug designation for HCC. Immunitor Inc. ... Numerous other molecular targeted drugs are being tested as alternative first- and second-line treatments for advanced HCC. ...
Investigational New Drugs. 27 (6): 491-502. doi:10.1007/s10637-008-9201-9. PMID 19009233. S2CID 28880438. v t e. ...
Staff (29 January 2013) FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder U.S. Food and Drug ... Investigational classes of hypolipidemic agents: *CETP inhibitors (cholesteryl ester transfer protein), 1 candidate is in ... They are called lipid-lowering drugs. These are drugs which lower the level of lipids and lipoproteins in blood. ... Hypolipidemic agents, cholesterol-lowering drugs or antihyperlipidemic agents, are a diverse group of pharmaceuticals that are ...
"U.S. Food and Drug Administration (FDA).. *Ebola: What You Need to Know - Scientific American articles related to Ebola; note ... "Investigational Monoclonal Antibody to Treat Ebola Is Safe in Adults" (Press release). National Institute of Allergy and ... "U.S. Food and Drug Administration (FDA) (Press release). 14 October 2020. Retrieved 14 October 2020.. This article incorporates ... "U.S. Food and Drug Administration (FDA) (Press release). 20 December 2019. Retrieved 22 December 2019.. ...
"Drug Trials Snapshots: Aklief". U.S. Food and Drug Administration (FDA). 11 October 2019. Archived from the original on 19 ... "Clinical, Cosmetic and Investigational Dermatology (Review). 2: 105-10. doi:10.2147/ccid.s3630. PMC 3047935. PMID 21436973.. ... Aslam I, Fleischer A, Feldman S (March 2015). "Emerging drugs for the treatment of acne". Expert Opinion on Emerging Drugs. 20 ... Aslam I, Fleischer A, Feldman S (March 2015). "Emerging drugs for the treatment of acne". Expert Opinion on Emerging Drugs ( ...
Current Opinion in Investigational Drugs. 9 (12): 1336-46. PMID 19037840.. *^ "Afatinib". US Food and Drug Administration. 12 ... In March 2010 a Phase III trial in NSCLC patients called Lux-Lung 5 began with this drug.[13] Fall 2010 interim results ... However, it is not active against the T790M mutation which generally requires third generation drugs like osimertinib.[11] ... In January 2015 a Phase III trial in people with NSCLC suggested the drug extended life expectancy in stage IV NSCLC ...
... "experimental and investigational".[77][78][79][80] Medicine-assisted manipulation, such as manipulation under anesthesia, ... American chiropractors found that a slight majority favored allowing them to write prescriptions for over-the-counter drugs.[37 ...
In 2005 the U.S. Food and Drug Administration (FDA) accepted Cortex Pharmaceuticals' Investigational New Drug (IND) application ... These drugs were reasonably effective at reducing the symptoms of Alzheimer's and it was hoped that they could also slow the ... Other AMPAkine drugs from Cortex Pharmaceuticals such as CX-546 and CX-614 have already been researched for use in treating ... CX-717 and CX-1739 are newer and more potent drugs in the same series. The chemical structures of CX-717 and CX-1739 have not ...
... (from U.S. Food and Drug Administration). *Some Relevant UK Statutory Instruments *The Medicines for ... GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational ... United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA),[1] they are not statutory ... Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". ...
This antineoplastic or immunomodulatory drug article is a stub. You can help Wikipedia by expanding it.. *v ... List of investigational hormonal agents § Estrogenics. References[edit]. *^ Gauthier, S; Cloutier, J; Dory, YL; Favre, A; ...
Investigational New Drug (IND) - IRB - ITP - IVIG ... drug resistance - drug-drug interaction - DSMB - Duffy antigen ... antiretroviral drugs - antisense drugs - antitoxins - Antiviral drug - aphasia - aphthous ulcer - apoptosis - approved drugs - ... multi-drug rescue therapy - multiple drug-resistant tuberculosis (MDR-TB) - mutation - myalgia - mycobacterium - mycobacterium ... fat redistribution - FDA FDC - floaters - follicle - follicular dendritic cells (FDCs) - Food and Drug Administration (United ...
Drug class. Estradiol, an important estrogen sex hormone in both women and men. ... List of investigational hormonal agents. *Sexual motivation and hormones. *Sex hormone therapy ...
"Clinical, Cosmetic and Investigational Dermatology. 9: 383-392. doi:10.2147/CCID.S76088. PMC 5076546 . PMID 27799808.. ... Several drugs can cause or worsen anxiety, whether in intoxication, withdrawal or from chronic use. These include alcohol, ... Anxiety disorders are partly genetic but may also be due to drug use, including alcohol, caffeine, and benzodiazepines (which ... sometimes with acute anxiety as soon as the drug effects wear off) and tend to be exaggerated. Acute exposure to toxic levels ...
War on Drugs. *Cannabinoid hyperemesis syndrome (CHS). *List of investigational analgesics. ReferencesEdit. *^ Marlowe, Douglas ... "The UN Drug Control Conventions". 8 October 2015.. *^ "Drug Schedules; Schedule 1". US Drug Enforcement Administration, ... such as in the United States where the National Institute on Drug Abuse and Drug Enforcement Administration continue to control ... US Food and Drug Administration. September 2004. Retrieved 14 January 2018.. *^ "Sativex Oromucosal Spray - Summary of Product ...
Asthma»։ in Mary Anne Koda-Kimble, Brian K. Alldredge։ Applied therapeutics: the clinical use of drugs (9th ed.)։ Philadelphia ... Custovic A, Simpson, A (2012)։ «The role of inhalant allergens in allergic airways disease»։ Journal of Investigational ... Zyflo (Zileuton tablets)»։ United States Food and Drug Administration։ Cornerstone Therapeutics Inc.։ June 2012։ էջ 1։ ... Heintze K, Petersen, KU (Jun 2013)։ «The case of drug causation of childhood asthma: antibiotics and paracetamol.»։ European ...
... and is an attractive target for new anti-HIV drugs. In November 2005, data from a phase 2 study of an investigational HIV ... Expert Opin Investig Drugs. 15 (12): 1507-22. doi:10.1517/13543784.15.12.1507. PMID 17107277. "FDA approves drug that fights ... "Scientists say crack HIV/AIDS puzzle for drugs". Reuters. January 31, 2010. Morales-Ramirez JO, Teppler H, Kovacs C, et al. ... On October 12, 2007, the Food and Drug Administration (U.S.) approved the integrase inhibitor Raltegravir (MK-0518, brand name ...
Within the United States, pre-approval demand is generally met through treatment IND (investigational new drug) applications ( ... Informations and Leaflets of approved pharmaceutical drugs , Medikamio. *SuperCYP: Database for Drug-Cytochrome- and Drug-Drug- ... anabolic drugs, haematopoietic drugs, food product drugs For neoplastic disordersEdit. cytotoxic drugs, therapeutic antibodies ... A medication (also referred to as medicine, pharmaceutical drug, or simply drug) is a drug used to diagnose, cure, treat, or ...
Casopitant is an investigational NK1 receptor antagonist. *Rolapitant (Varubi) another recently approved drug from this class ... "Drugs During Pregnancy and Lactation: Handbook of Prescription Drugs and Comparative Risk Assessment. Gulf Professional ... "Drug Scheduling". www.dea.gov. Retrieved 2019-02-21.. *^ "2017 - Final Rule: Placement of FDA-Approved Products of Oral ... An antiemetic is a drug that is effective against vomiting and nausea. Antiemetics are typically used to treat motion sickness ...
... is an exception for use in people with treatment-refractory gastrointestinal symptoms under an FDA Investigational New Drug ... "FDA warns against women using unapproved drug, domperidone to increase milk production." U.S. Food and Drug Administration 7 ... Youssef AS, Parkman HP, Nagar S (2015). "Drug-drug interactions in pharmacologic management of gastroparesis". ... Domperidone is the generic name of the drug and its INN, USAN, BAN, and JAN.[74][6][75] ...
Expert Opinion on Investigational Drugs. 25 (7): 771-80. doi:10.1080/13543784.2016.1175432. PMID 27077938.. ... Smith, MS; Muir, H; Hall, R (February 1996). "Perioperative management of drug therapy, clinical considerations". Drugs. 51 (2 ... The use of indirect sympathomimetic drugs or drugs affecting serotonin reuptake, such as meperidine or dextromethorphan poses a ... The drug was introduced by Smith, Kline and French in the United Kingdom in 1960, and approved in the United States in 1961.[22 ...
The Investigational Drugs Journal. 10 (9): 636-44. PMID 17786847.. ... "CHF 3381". Drugs in R&D. 5 (1): 28-30. 2004. doi:10.2165/00126839-200405010-00005. PMID 14725488.. ... Indantadol (CHF-3381, V-3381) is a drug which was formerly being investigated as an anticonvulsant and neuroprotective and is ...
Applied therapeutics: the clinical use of drugs (Edisi ke-9th). Philadelphia: Lippincott Williams & Wilkins. OCLC 230848069. ... Custovic, A; Simpson, A (2012). "The role of inhalant allergens in allergic airways disease.". Journal of investigational ... Chronic obstructive pulmonary disease". Applied therapeutics: the clinical use of drugs (Edisi ke-9th). Philadelphia: ...
"Journal of Drugs in Dermatology. 10 (12): 1363-9. PMID 22134559.. *^ Draelos, Zoe (2011). Cosmetic Dermatology: Products and ... "Clinical, Cosmetic and Investigational Dermatology. 8: 47-52. doi:10.2147/CCID.S69118. ISSN 1178-7015. PMC 4327394. PMID ... "Clinical, Cosmetic and Investigational Dermatology. 7: 201-205. doi:10.2147/CCID.S44371. PMC 4079633. PMID 25061326.. ... "Clinical, Cosmetic and Investigational Dermatology. 11: 499-503. doi:10.2147/ccid.s146258. ISSN 1178-7015. PMC 6199209. PMID ...
Martindale contains information on drugs in clinical use worldwide, as well as selected investigational and veterinary drugs, ... Martindale: The Complete Drug Reference is a reference book published by Pharmaceutical Press listing some 6,000 drugs and ... A chapter on supplementary drugs and other substances covers some 1190 monographs on new drugs, those not easily classified, ... drugs of abuse and recreational drugs, toxic substances, disinfectants, and pesticides. ...
Journal of Investigational Allergology & Clinical Immunology. 20 (5): 364-71, quiz 2 p following 371. PMID 20945601. Archived ( ... Antihistamine drugs can have undesirable side-effects, the most notable one being drowsiness in the case of oral antihistamine ... Antihistamine drugs can be taken orally and nasally to control symptoms such as sneezing, rhinorrhea, itching, and ... First-generation antihistamine drugs such as diphenhydramine cause drowsiness, while second- and third-generation ...
... is an investigational inhibitor being developed by AROG Pharmaceuticals, LLC. The compound is currently being evaluated for ... "Crenolanib Inhibits the Drug-Resistant PDGFRA D842V Mutation Associated with Imatinib-Resistant Gastrointestinal Stromal Tumors ...
This antineoplastic or immunomodulatory drug article is a stub. You can help Wikipedia by expanding it.. *v ... Pexelizumab is a drug designed to reduce side effects of coronary artery bypass grafting[1] and angioplasty,[2][3] among other ... Alexion, the developer of pexelizumab, stopped development when the phase 3 trial indicated the heart-attack drug is no better ...
Gainer, J (2008). "Trans-sodium crocetinate for treating hypoxia/ischemia". Expert Opinion on Investigational Drugs. 17 (6): ... The drug has also been under investigation in a clinical trial sponsored by drug developer Diffusion Pharmaceuticals for ... is an experimental drug that increases the movement of oxygen from red blood cells into hypoxic (oxygen-starved) tissues.[8] ... The drug is currently under investigation for its possible use in enhancing the oxygenation status of COVID-19 patients at risk ...
Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs), are a drug class that groups together drugs that decrease ... Some novel and investigational analgesics include subtype-selective voltage-gated sodium channel blockers such as funapide and ... Other drugs[edit]. Main article: analgesic adjuvant. Drugs that have been introduced for uses other than analgesics are also ... "Drugs Used In The Treatment Of Interstitial Cystitis". Drug Treatment in Urology. John Wiley & Sons, 2008. p. 65.. ...
5,0 5,1 Micheli F (February 2001). "Lesopitron (Esteve)". IDrugs : the Investigational Drugs Journal 4 (2): 218-24. PMID ... "Drug Discov Today 15 (23-24): 1052-7. PMID 20970519. doi:10.1016/j.drudis.2010.10.003. edit ... "PubChem as a public resource for drug discovery.". ...
Sicherer SH, Leung DY (2007). "Advances in allergic skin disease, anaphylaxis, and hypersensitivity reactions to foods, drugs, ... Journal of investigational allergology & clinical immunology. 15 (2): 124-30. PMID 16047713.. Explicit use of et al. in: , ...
A jet injector is a type of medical injecting syringe device used for a method of drug delivery known as jet injection, in ... The piston is usually pushed by the release of a compressed metal spring, although investigational devices may use ... A new method of drug administration". Current Researches in Anesthesia and Analgesia. 26 (6): 221-230. PMID 18917536.. ... A laser based reusable microjet injector for transdermal drug delivery *^ "PharmaJet's Stratis® Needle-free Injector Receives ...
Investigational New Drugs provides a forum for the ... ... Investigational New Drugs cuts across all the usual lines or ... Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers ... Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of ... Provided they add to the understanding of the investigational agents, the journal is not adverse to publishing clinical trials ...
... final rules expanding access to investigational drugs for seriously ill patients who have no alternatives and regulating drug ... The guidelines allow patients to take an investigational drug or an approved drug for a new use under investigation under these ... To publicize the changes, the agency has established a new Web site on investigational drug access for consumers and healthcare ... WASHINGTON -- The FDA has issued two final rules expanding access to investigational drugs for seriously ill patients who have ...
... is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological ... Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that ... is not the subject of an approved New Drug Application or Biologics/Product License Application. ... Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) Information on Submitting an Investigational New Drug ...
... Written by Jill Stein. on March 1, 2017 ... Aspirin may strengthen anti-cancer drugs. Aspirin in conjunction with Sorafenib - an anti-cancer drug -increases its ability to ... A new drug that specifically targets cancer cell metabolism has been discovered. It is switched on by a chemical found in ... The investigational compound savolitinib appears to have antitumor activity in patients with c-MET-driven papillary renal cell ...
Aspirin may strengthen anti-cancer drugs Aspirin in conjunction with Sorafenib - an anti-cancer drug -increases its ability to ... The investigational compound savolitinib appears to have antitumor activity in patients with c-MET-driven papillary renal cell ... Researchers suggest that the drug savolitinib might benefit patients with papillary renal cell carcinoma. ...
Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ICH ... The United States Food and Drug Administrations Investigational New Drug (IND) program is the means by which a pharmaceutical ... law to investigational use." Approximately two-thirds of both INDs and new drug applications (NDAs) are small-molecule drugs. ... Abigail Alliance for Better Access to Developmental Drugs Animal drug Drug discovery FDA Fast Track Development Program Good ...
Food and Drug Administration (FDA) accepted the Companys investigational new drug (IND) application for JCAR017 for patients ... Juno Announces FDA Acceptance of Investigational New Drug Application for JCAR017 in Relapsed/Refractory B Cell Non-Hodgkin ...
... is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological ... Information on Submitting an Investigational New Drug Application. *Federal Register Notice: New Drug and Biological Drug ... Preparation of Investigational New Drug Products (Human and Animal). *U.S. Food and Drug Administration Statement: The impact ... An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to ...
These are lists of investigational drugs: List of investigational analgesics List of investigational antidepressants List of ... List of investigational hormonal agents List of investigational sexual dysfunction drugs List of investigational sleep drugs. ... investigational antipsychotics List of investigational anxiolytics List of investigational hallucinogens and entactogens ...
... was made available in the United States through a Food and Drug Administration (FDA)--approved Investigational New Drug (IND) ... Notice to Readers: Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol. ... Availability of diphtheria antitoxin through an Investigational New Drug protocol. MMWR 1997;46:380. ...
Notice to Readers Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol Although diphtheria is a ... is now available in the United States through an Investigational New Drug (IND) protocol through CDC. This protocol is designed ...
Women with recurrent ovarian cancer can be helped by giving an investigational drug in combination with chemotherapy, according ... drug therapies, food and drug administration, gynecologic oncologist, investigational drug, liposomal doxorubicin, multicenter ... Investigational drug raises hope for ovarian cancer patients. September 16th, 2008 - 1:50 pm ICT by ANI Tweet. ... Washington, Sept 16 (ANI): Women with recurrent ovarian cancer can be helped by giving an investigational drug in combination ...
Investigational immunotherapy drug shrinks tumors in high-risk neuroblastoma patients. St. Jude Childrens Research Hospital ... Along with the investigational monoclonal antibody, study participants underwent multi-drug chemotherapy, surgery, radiation ... immunotherapy-drug-neuroblastoma-patients More in Medicine & Health. * European pregnancy rates from IVF and ICSI appear to ... Commonly prescribed drugs could increase the risk of dementia, says a new study University of Nottingham ...
The companies will develop tissue-based companion diagnostics for Amgens investigational treatment AMG 510 for non-small cell ... Home » Business, Policy & Funding » Business News » Qiagen, Amgen Collaborate to Develop CDx for Investigational NSCLC Drug ... Qiagen, Amgen Collaborate to Develop CDx for Investigational NSCLC Drug. Jan 14, 2020 ... MSK Study Finds Survival Gap Between Clinical Trial, Real-World Patients on Approved Cancer Drugs Premium ...
Andrea Baines and Ann Farrell explain the process of obtaining an investigational agent outside of a clinical trial through ... Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period. ... Food and Drug Administration, HHS. Expanded access to investigational drugs for treatment use: Final rule. Fed Regist. 2009;74: ... HHS, Food and Drug Administration, CDER, et al. Expanded Access to Investigational Drugs for Treatment Use - Questions and ...
... today announced the publication of a peer-reviewed paper in the August 2012 issue of Expert Opinion on Investigational Drugs ( ... Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, ... features make vosaroxin a particularly attractive chemotherapy agent including its resistance to P-glycoprotein-mediated drug ...
Doctors at the North Shore-LIJ Health System on Saturday will present late-breaking data showing that an investigational drug ... Investigational Drug Effective in Treating Iron Deficiency in Chronic Kidney Disease Patients on Dialysis: Study. ... Doctors at the North Shore-LIJ Health System, on Saturday, will present late-breaking data showing that an investigational drug ...
The investigational drug glofitamab showed promising outcomes in patients with relapsed/refractory B-cell non-Hodgkin lymphoma ... Part 2, however, had better responses, with drug effects starting at the 0.6 milligram dose. At the 25-milligram dose, all ... The trial - which analyzed potential dosing strategies and safety for the drug - included 171 pretreated patients with B-NHL: ... Investigational Drug Shows Promise in Lymphoma Subsets. @media screen and (max-width: 468px) { .video-detail .doc-group- ...
... an investigational product from Ezra Innovations for the treatment of hypertension and heart failure. ... The FDA has accepted the new drug application (NDA) for EZR-201, ... FDA Accepts NDA for Investigational Hypertension Drug. JANUARY ... The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the ... The Prescription Drug User Fee Act goal date for EZR-201 has been set for September 10, 2017. The most recent FDA acceptance ...
The investigational drug patiromer quickly reduced elevated blood-potassium levels -- a common life-threatening side effect of ... Investigational drug prevents life-threatening side effects of kidney disease treatment First study of long-term benefits from ... Investigational drug prevents life-threatening side effects of kidney disease treatment. University of Chicago Medical Center ... A yearlong study of more than 300 patients found that the investigational drug patiromer can reduce elevated blood-potassium ...
Food and Drug Administration (FDA) has cleared the companys Investigational New Drug Application (IND) for voruciclib ... Food and Drug Administration (FDA) has cleared the companys Investigational New Drug Application (IND) for voruciclib, an ... MEI Pharma Announces FDA Clearance of Investigational New Drug Application for CDK Inhibitor Voruciclib. ... Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as ...
Drug Exposure Registry for GSK2248761, an Investigational NNRTI. Official Title ICMJE Drug Exposure Registry for Long-Term ... Drug Exposure Registry for GSK2248761, an Investigational NNRTI. The safety and scientific validity of this study is the ... investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal ... Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have produced recent evidence that some ...
... and Ipsen Biopharmaceuticals reported the preclinical discovery and early-stage clinical development of this novel drug. ... Investigational drug may hold benefit for patients with lung and ovarian cancers. *Download PDF Copy ... Posted in: Drug Trial News , Medical Condition News , Womens Health News. Tags: Asparagine, Blood, Cancer, Cancer Therapy, ... IACS drug-discovery scientists identified IPN60090 as a potent and selective inhibitor of GLS1 suitable for clinical trials, ...
Drug Exposure Registry for GSK2248761, an Investigational NNRTI. The safety and scientific validity of this study is the ... investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal ... Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have produced recent evidence that some ... Drug Exposure Registry for Long-Term Follow-Up of Subjects Exposed to GSK2248761. ...
Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinsons disease. ... has announced that Kyowa Pharmaceutical, Inc., its wholly owned U.S subsidiary, submitted on April 25, 2007 a new drug ... Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinsons disease. Parkinsons ... Submission of NDA for Istradefylline(KW-6002), an investigational anti-Parkinsons disease drug. *Download PDF Copy ...
Drugs.com Mobile Apps. The easiest way to lookup drug information, identify pills, check interactions and set up your own ... Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and ... Home › News › Clinical Trials › Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium ... Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile. Print this page ...
... today announced that the companys oncology drug candidate, NKTR-102, has been... ... About Orphan Drug Designation in the U.S.. In the United States, the Orphan Drugs Act (ODA) provides for the orphan drug ... FDA Grants Orphan Drug Designation for Nektars Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer. ... FDA Grants Orphan Drug Designation for Nektars Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer ...
PRNewswire/ -- StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved ... StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and Drug Administration (FDA) ... approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical ... 3, 2019 /PRNewswire/ -- StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018 ...
Drugs Approvals and Trials*Environmental Health*Health Informatics*Legal and Regulatory*Life style and Fitness*Medical ...
  • SNSS ) today announced the publication of a peer-reviewed paper in the August 2012 issue of Expert Opinion on Investigational Drugs (Volume 21, Number 8) featuring vosaroxin, the Company's lead product candidate currently being evaluated in a Phase 3 trial, the VALOR trial, for the treatment of relapsed or refractory acute myeloid leukemia (AML). (globenewswire.com)
  • Expert Opinion on Investigational Drugs. (wikipedia.org)
  • SEATTLE, June 29, 2015 (GLOBE NEWSWIRE) -- Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) accepted the Company's investigational new drug (IND) application for JCAR017 for patients with relapsed/refractory (r/r) B cell non-Hodgkin lymphoma, or NHL. (globenewswire.com)
  • LOS ANGELES--( BUSINESS WIRE )-- ImmunoCellular Therapeutics, Ltd. ('ImmunoCellular') (NYSE MKT: IMUC) announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial. (aol.com)
  • The article ImmunoCellular Therapeutics' Investigational New Drug (IND) Application for ICT-140 Allowed by the FDA originally appeared on Fool.com. (aol.com)
  • In a first-time disclosure of IPN60090, a small-molecule inhibitor of the metabolic enzyme glutaminase (GLS1), researchers from The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division and Ipsen Biopharmaceuticals reported the preclinical discovery and early-stage clinical development of this novel drug. (news-medical.net)
  • Identifying these putative predictive biomarkers of response is critical for our ongoing clinical efforts to ensure that we're able to offer patients the most relevant therapies,' said Timothy A. Yap, M.B.B.S., Ph.D., F.R.C.P., associate professor of Investigational Cancer Therapeutics and medical director of IACS. (news-medical.net)
  • Oct. 31, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for its drug candidate ATI-50001 for the treatment of alopecia universalis and alopecia totalis. (cnbc.com)
  • Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. (cnbc.com)
  • CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic, for designation as an orphan medicinal product for the treatment of transthyretin (TTR)-mediated (ATTR) amyloidosis. (businesswire.com)
  • Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. (centerwatch.com)
  • Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted an investigational new drug application (IND) to the Food and Drug Administration for a first-in-human study of RX-5902 to treat advanced or metastatic solid tumors. (thestreet.com)
  • The US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application to PLX-200, developed by Polaryx Therapeutics, for the treatment of late infantile neuronal ceroid lipofuscinosis (LINCL or CLN2) patients. (europeanpharmaceuticalreview.com)
  • In collaboration with Global Blood Therapeutics, our folks here at XVIVO created this medical animation to illustrate the mechanism of action of a potential drug candidate for the treatment of sickle cell disease (SCD). (xvivo.net)
  • The Investigational Drug Branch (IDB) implements and oversees an innovative investigational experimental therapeutics program. (unt.edu)
  • MONTREAL, May 15, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced new positive results for its investigational Sortilin (SORT1) targeting peptide-drug conjugates (PDCs) which will be presented in three posters during AACR's virtual annual meeting II on June 22, 2020. (biospace.com)
  • Washington, Sept 16 (ANI): Women with recurrent ovarian cancer can be helped by giving an investigational drug in combination with chemotherapy, according to new results presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. (thaindian.com)
  • Half the women received a combination therapy of trabectedin and a chemotherapy drug called pegylated liposomal doxorubicin. (thaindian.com)
  • The other half received the chemotherapy drug alone, which is standard treatment in these cases. (thaindian.com)
  • Along with the investigational monoclonal antibody, study participants underwent multi-drug chemotherapy, surgery, radiation and autologous hematopoietic stem cell transplantation. (eurekalert.org)
  • Several unique features make vosaroxin a particularly attractive chemotherapy agent including its resistance to P-glycoprotein-mediated drug efflux and its lack of chemical reactivity, which by not promoting the formation of reactive oxygen species, should minimize adverse effects, most notably cardiotoxicity. (globenewswire.com)
  • Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. (yahoo.com)
  • Daily online exclusives cover late breaking oncology news, safe handling and administration of chemotherapy drugs, side effect management, and new developments in specific cancers. (oncologynurseadvisor.com)
  • The researchers studied bone loss in mice treated with two common chemotherapy drugs - doxorubicin and paclitaxel - as well as in mice that received radiation to one limb, to understand whether the bone loss effects were similar in different types of cancer therapies. (wustl.edu)
  • The investigational antibody-drug conjugate showed an encouraging overall response rate (ORR) in patients who were previously treated with a checkpoint inhibitor. (curetoday.com)
  • GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate. (gsk.com)
  • The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process," added Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. (medpagetoday.com)
  • Dr. Bradley Monk, a UC Irvine gynecologic oncologist who led the worldwide phase III clinical trial, said trabectedin is the most recent addition to a short list of active drug therapies for recurrent ovarian cancer. (thaindian.com)
  • 1 These programs were established to provide access to investigational drugs (i.e., products that have not been FDA approved) outside of clinical trials to patients with serious or immediately life-threatening diseases or conditions for whom no satisfactory alternative therapies are available. (hematology.org)
  • For example, a patient may have exhausted all available therapies, have a contraindication to an approved drug, have a rare disease with no approved treatment, or fail to meet eligibility criteria for a clinical trial. (hematology.org)
  • The trial - which analyzed potential dosing strategies and safety for the drug - included 171 pretreated patients with B-NHL: 90.6% were refractory to prior therapy, with the average amount of prior therapies being three. (curetoday.com)
  • SAN DIEGO , Jan. 8, 2018 /PRNewswire/ -- MEI Pharma, Inc. ( MEIP ), an oncology company focused on the clinical development of novel therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug Application (IND) for voruciclib, an orally available Cyclin Dependent Kinase 9 (CDK9) inhibitor, for patients with relapsed/refractory B-cell malignancies. (yahoo.com)
  • Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have produced recent evidence that some antiretroviral therapies may have neurotoxic effects, warranting further research. (clinicaltrials.gov)
  • These results, although preliminary and difficult to compare, have attracted a lot of attention among physicians and patients considering standard and other investigational therapies for kidney cancer. (uchospitals.edu)
  • WHIPPANY, N.J., May 17, 2017 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. (drugs.com)
  • A new investigational drug has demonstrated high response rates in patients with a rare but highly aggressive blood disease that currently has no approved therapies, according to new research led by investigators at The University of Texas MD Anderson Cancer Center. (ajmc.com)
  • Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. (businesswire.com)
  • The drug was even more active when combined with traditional lung cancer treatments and other investigational targeted therapies, according to preclinical study data. (bio-medicine.org)
  • A Phase I/II study, led by investigators at The University of Texas MD Anderson Cancer Center , reports an investigational drug called tagraxofusp has demonstrated high response rates in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare but highly aggressive - and often fatal bone marrow and blood disorder - for which there are no existing approved therapies. (mdanderson.org)
  • SAN MATEO, Calif., June 3 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration for the clinical development of NGX-1998, the Company's product candidate utilizing a high-concentration liquid formulation of capsaicin. (fiercehealthcare.com)
  • Like you, PPMD has had many questions about the way we can access UNAPPROVED investigational therapies in Duchenne. (parentprojectmd.org)
  • The "Latest Advances in Quantum Computing, Drug Delivery, and Investigational Therapies for Diabetes and Other Disorders" report has been added to ResearchAndMarkets.com's offering. (pharmiweb.com)
  • Each and every platform is accurately profiled covering the most cutting-edge technologies energizing the pharmaceutical landscape, such as quantum computing in life sciences, innovations in drug delivery, and novel investigational therapies for diabetes and other disorders. (pharmiweb.com)
  • Investigational Device Exemption (IDE) content and application process, regulatory requirements and best practices. (complianceonline.com)
  • Under FDA's investigational device exemption ("IDE") regulations, a clinical study of an IVD product is generally exempt from IDE requirements if the product (1) is non-invasive, (2) does not require invasive sampling that poses significant risk, (3) does not introduce energy into a subject by design or intention, and (4) is not be used for diagnosis without confirmation by another medically established diagnostic procedure or product. (mondaq.com)
  • The Company's portfolio of drug candidates includes pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. (yahoo.com)
  • NKTR ) today announced that the company's oncology drug candidate, NKTR-102, has been granted orphan drug status for the treatment of women with ovarian cancer by the U.S. Food and Drug Administration (FDA). (prnewswire.com)
  • Canalevia™ is the Company's lead prescription drug product candidate for the treatment of various forms of watery diarrhea in dogs. (fiercepharma.com)
  • EDMONTON , March 24, 2020 /PRNewswire/ - OncoQuest Inc. ('OncoQuest' or the 'Company'), a privately held, cancer immunotherapy company today announced the publication of two reports relating to the recently completed Phase 2 trial conducted in the US and Italy utilizing oregovomab, the Company's lead investigational drug in frontline ovarian cancer. (yahoo.com)
  • patient has been treated in a second Phase 3 clinical study of investigational vonapanitase (formerly PRT-201), the company's lead product candidate. (bioportfolio.com)
  • We are pleased that the FDA has accepted our proposal for an investigational new drug application to pursue LJPC-501 in patients with hepatorenal syndrome," said George Tidmarsh, the company's president and CEO, in a statement. (sdbj.com)
  • Sept. 4, 2014 (GLOBE NEWSWIRE) - Cellectar Biosciences, Inc. (Nasdaq:CLRB), announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application to begin clinical study of I-131-CLR1404, a highly-selective, cancer-targeting radiopharmaceutical, in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells. (wisbusiness.com)
  • Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. (fda.gov)
  • The U.S. Food and Drug Administration (FDA) has mechanisms in place to facilitate access to investigational drugs (including biologics) for treatment use through expanded access programs, sometimes referred to as "compassionate use" programs. (hematology.org)
  • FDA logo The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. (statemaster.com)
  • In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. (complianceonline.com)
  • In September 2012 , MedImmune, the global biologics research and development arm of AstraZeneca , and WuXi AppTec formed the joint venture WuXi MedImmune Biopharmaceutical Co. Limited to develop and commercialize MEDI5117, a novel, investigational, long-acting monoclonal antibody for autoimmune and inflammatory diseases, the first such collaboration in China between a global company and a Chinese company to develop novel biologics. (wuxiapptec.com)
  • This is a list of investigational sleep drugs, or drugs for the treatment of sleep disorders that are currently under development for clinical use but are not yet approved. (wikipedia.org)
  • This treatment undoubtedly will be evaluated carefully by the U.S. Food and Drug Administration and, if approved, will give women with ovarian cancer another much needed option, Monk added. (thaindian.com)
  • Such a study is often the last step before a drug is reviewed by a regulatory agency like the FDA for approval as a safe, effective treatment. (thaindian.com)
  • NEW YORK - Qiagen said after the close of the market on Monday that it is collaborating with Amgen to develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer (NSCLC). (genomeweb.com)
  • She is informed that access to an investigational drug outside of a clinical trial might be possible, but it is not clear whether treatment can be arranged quickly. (hematology.org)
  • and 3) for widespread use in larger patient populations through an investigational new drug (IND) application (also known as a treatment IND) or treatment protocol. (hematology.org)
  • The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the treatment of hypertension and heart failure. (pharmacytimes.com)
  • A yearlong study of more than 300 patients found that the investigational drug patiromer can reduce elevated blood-potassium levels--a common side effect of drugs essential in the treatment of chronic diabetic kidney disease. (eurekalert.org)
  • Another 42 percent (45 patients) had their tumors stabilize within 25 percent of pre-treatment size, which met the criteria for randomization to drug or placebo. (uchospitals.edu)
  • In the United States , the Orphan Drugs Act (ODA) provides for the orphan drug designation which aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. (prnewswire.com)
  • In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for NKTR-118, an investigational drug candidate, being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation. (prnewswire.com)
  • BALDWIN PARK, Calif. , Jan. 3, 2019 /PRNewswire/ -- StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018 , approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury. (prnewswire.com)
  • Copanlisib has also been granted Orphan Drug Designation for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma. (drugs.com)
  • The most recent drug candidate in Jaguar's pipeline is being developed for the treatment of obesity-related metabolic dysfunction in dogs, which manifests in altered lipid profiles, insulin resistance and mild hypertension. (fiercepharma.com)
  • The prescription drug candidate has been previously evaluated in Phase 2 studies in humans, and is also the subject of INADs previously filed by Jaguar for the treatment of Type II diabetes in cats and metabolic syndrome in horses. (fiercepharma.com)
  • Data from the oral presentation " Increasing potency of anticancer drugs through Sortilin receptor-mediated cancer therapy: A new targeted approach for the treatment of ovarian cancer ," show that both TH1902 (docetaxel peptide conjugate) and TH1904 (doxorubicin peptide conjugate), two unique Sortilin positive (SORT1+) targeting investigational PDCs, are more effective and better tolerated in animal models than two commonly-used ovarian cancer treatments. (biospace.com)
  • The FDA has approved King Pharmaceutical's [KG] investigational new drug application for T-62, a treatment for neuropathic pain. (rutgers.edu)
  • A phase I trial to determine the safety of T-62, a new chemical entity, is now planned to begin during the fourth quarter of 2003.The trial represents an important step forward in providing patients who suffer from neuropathic pain with the first orally administered product in a new class of investigational agents indicated for the treatment of this prevalent condition. (rutgers.edu)
  • With potent and durable TTR knockdown, we believe ALN-TTRsc02 holds great promise as an investigational, once-quarterly, low volume, subcutaneously administered RNAi therapeutic for the treatment of a broad spectrum of patients with ATTR amyloidosis. (businesswire.com)
  • ALN-TTRsc02 is an investigational, subcutaneously administered RNAi therapeutic targeting transthyretin (TTR) in development for the treatment of ATTR amyloidosis. (businesswire.com)
  • This Team Master's Project was primarily focused on Samumed's investigational drug, SM04690, which is currently being developed for the treatment of pain associated with knee osteoarthritis (OA). (kgi.edu)
  • The clinical experience of human immunodeficiency virus (HIV) + patients treated with oral atovaquone for acute Pneumocytstis carinii pneumonia (PCP) under a Treatment Investigational New Drug (IND) protocol (mild or moderate PCP) and an Open-Label Study protocol (severe PCP) was evaluated. (rti.org)
  • RARE ), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, today announced that GeneTx's Investigational New Drug (IND) Application for GTX-102, an experimental antisense oligonucleotide being evaluated for the treatment of Angelman syndrome (AS), filed with the U.S. Food and Drug Administration (FDA) is now active. (benzinga.com)
  • Eli Lilly announced positive results from a Phase 3 trial (SPARTAN) of their first-in-class drug lasmiditan for the acute treatment of migraine. (empr.com)
  • The investigational drug PF-06463922 has the potential to become a new treatment option for patients who have lung cancer that harbors abnormalities in the ALK gene. (oncologynurseadvisor.com)
  • Knowing how the drug exerts its effects is a critical step toward establishing oxytocin as a drug treatment for overeating and obesity," said the study's lead investigator, Liya Kerem, M.D., M.Sc. (medicalxpress.com)
  • An investigational treatment associated with this study has been approved for sale to the public. (clinicaltrials.gov)
  • using and willing to continue using a highly effective form of birth control for at least 28 days prior to administration of the first dose of study drug, during the treatment period, and 2 months after completion or premature discontinuation from the study drug. (centerwatch.com)
  • The company has advanced a unique repurposing drug development strategy to provide patients with a safe and effective oral treatment option. (europeanpharmaceuticalreview.com)
  • Expanded Access for Individual Patients is used to make experimental new drugs, under review for approval at the U.S. Food and Drug Administration ("FDA"), available to individual patients with serious or life-threatening diseases for which there is no comparable alternative treatment. (parentprojectmd.org)
  • The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. (nih.gov)
  • The Centers for Disease Control and Prevention (CDC) now has an expanded access investigational new drug (IND) protocol in effect with the Food and Drug Administration (FDA) to make miltefosine available directly from the CDC to clinicians for treatment of free-living ameba (FLA) infections in the United States. (infectioncontroltoday.com)
  • Although several drugs have in vitro activity against FLA, mortality from these infections remains greater than 90 percent despite treatment with combinations of drugs. (infectioncontroltoday.com)
  • The CDC now has an expanded access IND protocol in effect with the Food and Drug Administration to make miltefosine available directly from CDC for treatment of FLA in the United States. (infectioncontroltoday.com)
  • Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), the most common form of head and neck cancer, may benefit from treatment with the investigational drug dacomitinib if their cancer has no defects in the PI3K cell signaling pathway and no signs of excessive inflammation. (oncologynurseadvisor.com)
  • Preclinical data indicated that treatment with an investigational gene therapy product slowed the loss of visual function in canines with XLRP caused by mutations in the RPGR gene. (blindness.org)
  • Together with Peregrine, we helped depict the mechanism of action behind Bavituximab, an investigational treatment that helps the body recognize cancer cells. (xvivo.net)
  • We have examined the response of 64 sarcoma cell lines to treatment with 103 approved oncology drugs (available from The NCI/DTP Open Chemical Repository) and 420 agents in the investigational agents library, using inhibition of proliferation as an endpoint. (aacrjournals.org)
  • Thus the combination of drug sensitivity data, together with the gene and miRNA profiles may allow correlations in treatment efficacy that may point to new avenues for clinical development in sarcoma. (aacrjournals.org)
  • OXFORD, UK / ACCESSWIRE / March 13, 2019 / IntraBio Inc., a late-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for Clinical Trial IB1001-203 with its lead compound (IB1001) for the treatment of Ataxia-Telangiectasia (A-T). (itbusinessnet.com)
  • The FDA's approval of our IND is a significant milestone for both patients and IntraBio," said Mallory Factor, Chairman of IntraBio Inc. "Given the extremely debilitating nature of this disease and the lack of any approved US drug, we are excited to continue moving forward to bring our novel treatment to patients in need. (itbusinessnet.com)
  • WASHINGTON -- The FDA has issued two final rules expanding access to investigational drugs for seriously ill patients who have no alternatives and regulating drug developers' charges for those medicines. (medpagetoday.com)
  • FDA officials said the rules essentially clarify three decades of piecemeal changes in FDA policy regarding investigational drugs for patients who are out of options but don't qualify for a clinical trial. (medpagetoday.com)
  • The changes permit drug manufacturers to charge patients under a broader range of circumstances than are explicitly stated in the current regulations, the FDA said. (medpagetoday.com)
  • The investigational compound savolitinib appears to have antitumor activity in patients with c-MET-driven papillary renal cell carcinoma, according to the results of a phase II study released at the 2017 Genitourinary Cancers Symposium in Orlando, FL. (medicalnewstoday.com)
  • In patients on the combination therapy, researchers found no progression of the cancer for an average of 7.3 months, as compared to 5.8 months for those treated with the single drug. (thaindian.com)
  • In similar patients enrolled in a previous national trial, tumor size decreased in only 40 percent of patients treated with the same drugs but without hu14.18K322A. (eurekalert.org)
  • Doctors at the North Shore-LIJ Health System, on Saturday, will present late-breaking data showing that an investigational drug Triferic is well tolerated and effective in treating iron deficiency in patients with chronic kidney disease undergoing dialysis. (prweb.com)
  • The investigational drug glofitamab showed promising outcomes in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), according to results from a phase 1 study published in the Journal of Clinical Oncology . (curetoday.com)
  • ME-522) has been tested in more than 70 patients in multiple solid tumor Phase 1 studies and has been associated with side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea. (yahoo.com)
  • The team has developed novel CLIA-certified assays to identify patients likely to benefit and monitor how effectively the drug is acting. (news-medical.net)
  • Interim results from a phase II trial of an investigational drug known as BAY 43-9006 or sorafenib demonstrate a significant and lasting benefit for a subset of patients with advanced renal cell cancer, researchers from the University of Chicago and four other centers report at the American Society of Clinical Oncology annual meeting in New Orleans, June 5. (uchospitals.edu)
  • This drug appears to cause tumor regression in a subset of patients, to maintain those regressions and to do it with limited toxicity,' said the study's lead investigator, Mark Ratain, MD, professor of medicine and chief of clinical pharmacology at the University of Chicago. (uchospitals.edu)
  • These patients had a very encouraging response to this drug even though most of them had advanced disease that had not responded to at least one and sometimes several previous systemic treatments. (uchospitals.edu)
  • This drug appears to be active in a large proportion of treated patients. (uchospitals.edu)
  • Most phase II trials test the effects of a new drug on patients with a specific disease, such as colon cancer, and limit the goal to determining the percentage of patients who have at least a 50 percent reduction in tumor size. (uchospitals.edu)
  • This approach allows us to test a new drug for effects in many tumor types and then concentrate on patients most likely to benefit,' said Ratain, who designed the study, only the second of its kind. (uchospitals.edu)
  • Istradefylline(KW-6002) is a novel investigational anti-Parkinson's drug that has a specific antagonistic action on the Adenosine A2A receptor in the brain and is expected to provide benefit to patients with Parkinson's disease. (news-medical.net)
  • MC001 is a regenerative cell therapy drug, which is designed to regenerate neurons in patients who suffered chronic, severe, stable spinal cord injury. (prnewswire.com)
  • The FDA closed its medical marijuana IND program (the Compassionate Use Program ) in 1992 , facing an influx of AIDS patients seeking access to the drug. (statemaster.com)
  • The Compassionate Use Program is the Investigational New Drug program allowing a limited number of patients to use National Institute on Drug Abuse-provided medical marijuana grown at the University of Mississippi. (statemaster.com)
  • This study will compare the investigational drug ifetroban to a placebo for improving symptoms and quality of life in patients with AERD. (scripps.org)
  • Despite pre-clinical data suggesting marked efficacy of pimecrolimus in suppressing neointimal hyperplasia, the extent of tissue growth and resulting rates of target vessel revascularization at six months were high in patients treated with this drug, said Stefan Verheye, MD, PhD, co-director of the catheterization laboratories at Antwerp Cardiovascular Center, ZNA Middelheim Hospital, Antwerp, Belgium. (bio-medicine.org)
  • A proposed piece of legislation would allow terminally ill patients to access drugs and medical devices that have not yet received approval from the US Food and Drug Administration (FDA). (raps.org)
  • So why should the FDA deny terminally ill patients access to drugs, devices, and treatments that the patient's physicians have determined represents the patent's only possible chance for survival? (raps.org)
  • Patients wishing to access drugs may also face a non-governmental hurdle in their face to obtain investigational new drugs and devices: the companies themselves. (raps.org)
  • Vonapanitase, a locally acting recombinant human elastase, is an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD. (bioportfolio.com)
  • Assessing an investigational therapy that aims to address the underlying cause of this devastating disorder has the potential to meaningfully alter the clinical course of patients' lives. (benzinga.com)
  • Patients are continuing to be enrolled for the next stage of the clinical trial which will ensure ongoing access to the drug. (mdanderson.org)
  • The drug is also being investigated in other clinical trials, including for patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis. (mdanderson.org)
  • The U.S. Food and Drug Administration has agreed that La Jolla Pharmaceutical Co. has enough data to support an investigational new drug application for a drug that treats patients with hepatorenal syndrome, a life-threatening form of kidney failure in patients with serious liver disease. (sdbj.com)
  • The drug, called LJPC-501, helps kidneys balance body fluids and electrolytes, and pre-clinical studies have shown that the drug can improve kidney function in patients with the disease. (sdbj.com)
  • An online tool to guide patients, caregivers and their physicians through the process for requesting single-patient expanded access for unapproved investigational drugs. (feinsteininstitute.org)
  • This drug is commonly used in patients with hodgkin lymphoma and anaplastic large cell lymphoma. (mesotheliomaguide.com)
  • Since adcetris works by interfering with the growth and spread of cancer cells that are inside the body, researchers believe that this investigational approach may help patients that are combating mesothelioma. (mesotheliomaguide.com)
  • The Lesinurad study involved 208 gout patients who had high blood urate levels for at least A few months, even while taking the gout drug allopurinol. (omex3.com)
  • Like Lesinurad, BCX4208 was studied in gouty arthritis patients who had experienced high blood urate levels for at least 6 months, despite taking the gout drug allopurinol. (omex3.com)
  • But individual responses in order to drugs vary, and gout patients will benefit from having two new approaches to relieving the symptoms of this painful condition. (omex3.com)
  • Manufacturers enroll patients into clinical trials to obtain data about the drug, which the manufacturer may ultimately submit to FDA in support of an application to market the drug in the U.S. This research is heavily regulated and generally will be done under and IND from the FDA. (parentprojectmd.org)
  • RTT allows seriously ill patients to bypass the FDA and obtain an investigational drug with the approval of the patient's doctor, if the drug manufacturer agrees to supply it. (parentprojectmd.org)
  • Of those patients, 6,461 received a bare metal stent (BMS), 5,743 patients received a drug-eluting stent (DES), and 640 patients received both BMS and DES at the time of enrollment. (fiercebiotech.com)
  • A 20 percent relative reduction favoring prasugrel was observed in the primary endpoint in patients who received only a bare metal stent (10.0 percent vs. 12.2 percent, p=0.003), and in patients who received only a drug-eluting stent, results showed an 18 percent relative reduction in the primary endpoint favoring prasugrel (9.0 percent vs. 11.1 percent, p=0.019). (fiercebiotech.com)
  • By using our biomarker data to select those patients who are most likely to benefit from the drug-those without PI3K pathway alteration or overexpression of proinflammatory cytokines-the trial will be more likely to succeed. (oncologynurseadvisor.com)
  • This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old. (nih.gov)
  • Aerie's first product, Rhopressa ® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. (yahoo.com)
  • A new study tested the investigational drug in combination with proton pump inhibitors for patients with gastroesophageal reflux disease. (drugtopics.com)
  • GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent. (gsk.com)
  • Together, IntraBio's team translates innovative scientific research in the fields of lysosomal biology, autophagy, and neurology into novel drugs for a broad spectrum of genetic and neurodegenerative diseases so to significantly improve the lives of patients and their families. (itbusinessnet.com)
  • The safety and efficacy of ALN-TTRsc02 have not been evaluated by the U.S. Food and Drug Administration, European Medicines Agency or any other health authority. (businesswire.com)
  • This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use. (hovione.com)
  • Elagolix for the management of HMB associated with uterine fibroids is investigational and its safety and efficacy have not been evaluated by any regulatory authorities. (rttnews.com)
  • The safety and efficacy of IW-3718, an investigational drug that binds bile acid in the stomach, was evaluated as an adjunct to PPI therapy in a clinical study. (drugtopics.com)
  • The primary purpose is to provide access rather than obtain information about the safety or efficacy of an investigational drug. (hematology.org)
  • In the study, we evaluated the 28-day efficacy of a single topical application of the RT001 drug products tested. (globenewswire.com)
  • Monitors clinical trials of anti-cancer drugs for safety, efficacy, and clinical pharmacology. (unt.edu)
  • OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway. (drugdiscoveryonline.com)
  • Phase III studies are multicenter trials on large patient groups designed to be the definitive assessment of a drug''s effectiveness. (thaindian.com)
  • In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to centralized marketing authorization. (businesswire.com)
  • Rexahn currently has three drug candidates in Phase II clinical trials, Archexin®, Serdaxin®, and Zoraxel™ and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. (thestreet.com)
  • During this phase 2 study, researchers will also be analyzing the safety of this drug. (mesotheliomaguide.com)
  • More not too long ago, shares of BioCryst Pharmaceuticals rose 12% upon the release of the results of its phase 2b randomized, double-blind, study with the investigational gout drug BCX4208. (omex3.com)
  • The drug must have completed Phase 1 clinical trials and be the subject of an active IND. (parentprojectmd.org)
  • Sativex and a related tetrahydrocannabinol (THC) medicine have been investigated in Phase II / III trials for the relief of cancer pain, an indication for which Bayer also has the option to market the drugs. (drugdevelopment-technology.com)
  • Develops drug development plans, including Phase I, Phase II and Phase III trials, for anti-cancer agents and coordinates with both intramural and extramural investigators and the pharmaceutical industry in the design and the conduct of these trials. (unt.edu)
  • Works closely with the Investigational Drug Steering Committee and its Task Forces to increase the transparency and openness of the trial design and prioritization process, achieve optimal phase I and phase II trial designs for the most promising agents and, ultimately, increase the predictive value of early phase trials, resulting in the design of more successful phase III trials. (unt.edu)
  • MONTREAL, April 27, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. . (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that new positive results about its two investigational peptide-drug conjugates (PDC) TH1902 and TH1904 will be presented tomorrow during an oral presentation at a virtual session of the Annual Meeting of the American Association for Cancer Research (AACR). (biospace.com)
  • CAMBRIDGE, Mass.--( BUSINESS WIRE )--AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy (VST) designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). (businesswire.com)
  • COPENHAGEN, Denmark, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon(TM) technologies to create product candidates that address unmet medical needs, today announced the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration to initiate the clinical program of TransCon TLR7/8 Agonist. (barrons.com)
  • The Prescription Drug User Fee Act goal date for EZR-201 has been set for September 10, 2017. (pharmacytimes.com)
  • SAN DIEGO The investigational drug ganetespib, a synthetic second-generation Hsp90 inhibitor, slowed the growth of cancer cells taken from non-small cell lung cancer tumors with a mutation in the KRAS gene. (bio-medicine.org)
  • An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. (fda.gov)
  • In 1997, an equine DAT product manufactured by Pasteur Merieux (Lyons, France) was made available in the United States through a Food and Drug Administration (FDA)--approved Investigational New Drug (IND) protocol ( 2 ). (cdc.gov)
  • Kyowa Hakko Kogyo Co. has announced that Kyowa Pharmaceutical, Inc., its wholly owned U.S subsidiary, submitted on April 25, 2007 a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinson's disease. (news-medical.net)
  • The Food and Drug Administration 's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. (statemaster.com)
  • Center for Drug Evaluation and Research, Food and Drug Administration. (statemaster.com)
  • Both trials are now approved by the U.S. Food and Drug Administration (FDA) and our Institutional Review Board, and we are expecting shipment of the experimental drug remdesivir in the next couple of days. (uhhospitals.org)
  • Intercept Pharmaceuticals is awaiting a US Food and Drug Administration (FDA) review of its obeticholic acid drug Ocaliva in NASH after a number of delays, first in January and then again in May, with the latter due to the ongoing COVID-19 pandemic. (pmlive.com)
  • Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications. (bioportfolio.com)
  • GTX-102 has been granted Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA). (benzinga.com)
  • Dependent on further input from the Data Safety Monitoring Board (DSMB) and the Food and Drug Administration (FDA), the Company stated that they intend on moving forward with the study and expect to report results in the first quarter of 2018. (empr.com)
  • The company is planning to submit a New Drug Application for lasmiditan to the Food and Drug Administration in the second half of 2018. (empr.com)
  • Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA). (drugdiscoveryonline.com)
  • Tagraxofusp received a Breakthrough U.S. Food and Drug Administration therapy designation with a rolling biological license application submitted to the FDA. (mdanderson.org)
  • NeurogesX' marketing authorization application (MAA) to the European Medicines Agency (EMEA) was accepted for review in September 2007 and NeurogesX plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2008 for PHN. (fiercehealthcare.com)
  • Cork, Ireland, 27th of November 2014 - Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA). (hovione.com)
  • This gap analysis is conducted prior to an initial meeting with the U.S. Food and Drug Administration (FDA) to identify potential deficiencies in the preclinical development program of a new chemical entity being considered for human clinical trials. (b3cnewswire.com)
  • IACS drug-discovery scientists identified IPN60090 as a potent and selective inhibitor of GLS1 suitable for clinical trials, and translational researchers in TRACTION demonstrated its activity against subsets of lung and ovarian cancer preclinical models. (news-medical.net)
  • Our goal is to take advantage of everything we have learned about designing drugs that target kinases like ALK and the ways in which lung cancers become resistant to crizotinib to develop the best next-generation ALK inhibitor we can. (oncologynurseadvisor.com)
  • The investigational drugs, a p38MAPK inhibitor and a MK2 inhibitor, block different parts of the same pathway leading to bone loss. (wustl.edu)
  • Ardea Biosciences had been the first to announce productive clinical trials of its experimental gout drug RDEA594, also called Lesinurad. (omex3.com)
  • If the patient is eligible, the patient enrolls in the study and is given either the experimental drug or a placebo drug. (parentprojectmd.org)
  • CLEVELAND - University Hospitals has secured two clinical trials that will provide the investigational antiviral drug remdesivir to hospitalized adults with a pneumonia due to the novel coronavirus. (uhhospitals.org)
  • Participants will receive study drug or placebo once daily for up to 8 weeks, and will have a telephone visit at week 1 with additional clinic follow-up visits at 4, 8, and 10 weeks. (scripps.org)
  • Janssen Pharmaceuticals reported high levels of sustained virologic response (SVR) in study participants using its investigational hepatitis C medication simeprevir (TMC435). (thebodypro.com)
  • The number of participants who prematurely discontinued study drug due to adverse events was tabulated. (nih.gov)
  • The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening). (nih.gov)
  • London, Ontario, May 11, 2010 / b3c newswire / - Critical Outcome Technologies Inc. (COTI) (TSX Venture: COT) announced today that it received a favourable Pre-Investigational New Drug (pre-IND) gap analysis report from an independent team that reviewed its novel oncology drug candidate COTI-2. (b3cnewswire.com)
  • Abstract C103: Sarcoma cell line sensitivity towards approved oncology drugs and investigational agents identifies distinct patterns of response which can be interrogated with associated gene expression. (aacrjournals.org)
  • Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations. (statemaster.com)
  • The GENESIS study was also designed to a novel stent design featuring reservoirs that are filled individually with an active drug and resorbable polymer matrix. (bio-medicine.org)
  • A patient learns that a clinical trial exists to study a drug for a condition, either from advertisements, their treating physician, or from clinicaltrials.gov , where most studies are required to be listed. (parentprojectmd.org)
  • The drug, given in this trial at one of four doses based on disease severity, returned blood potassium levels to normal when measured at four weeks and kept them under control for one year, the length of the trial. (eurekalert.org)
  • Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor. (statemaster.com)
  • TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. (barrons.com)
  • Voxelotor is an investigational disease-modifying drug that binds to hemoglobin and increases its affinity to oxygen, keeping it in its oxygenated state. (xvivo.net)
  • A new drug that specifically targets cancer cell metabolism has been discovered. (medicalnewstoday.com)
  • Aspirin in conjunction with Sorafenib - an anti-cancer drug -increases its ability to destroy malignant cells in some difficult-to-treat cancers. (medicalnewstoday.com)
  • Additional studies suggest that RX-5902 is effective in drug-resistant cancer cells and is synergistic when combined with current cancer drugs. (thestreet.com)
  • Researchers at the MD Anderson Cancer Center are investigating the use of the drug adcetris (brentuximab vedotin) to combat mesothelioma. (mesotheliomaguide.com)
  • About Orphan Drug Designation in the U.S. (prnewswire.com)
  • The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. (prnewswire.com)
  • Bayer is seeking Accelerated Approval of copanlisib for FL under FDA regulations 21 CFR Part 314 Subpart H. The compound was also granted Fast Track and Orphan Drug Designation by the FDA in this indication. (drugs.com)
  • We are very pleased to have received a positive opinion from the EMA COMP on our application for Orphan Drug Designation for ALN-TTRsc02," said Rena Denoncourt, Program Leader, ALN-TTRsc02 Program at Alnylam. (businesswire.com)
  • Special situations for IND submissions: Fast track, orphan drug designation, special protocol assessment. (complianceonline.com)
  • GSK2857916 has also received orphan drug designation from the EMA and FDA for multiple myeloma. (gsk.com)
  • To publicize the changes, the agency has established a new Web site on investigational drug access for consumers and healthcare professionals. (medpagetoday.com)
  • Miltefosine is a drug used to treat leishmaniasis and also has shown in vitro activity against FLA, but as an investigational drug, it has not been readily available in the United States. (infectioncontroltoday.com)
  • 2018 Advances in Quantum Computing, Drug Delivery, and In. (pharmiweb.com)
  • Adicet has won Investigational New Drug clearance from the FDA for ADI-001, a chimeric antigen receptor (CAR) gamma delta T-cell therapy for nonHodgkin's lymphoma. (fdanews.com)
  • When bound, the carrier inactivates and shields the parent drug from clearance. (barrons.com)
  • One new FDAAA provision, 42 U.S.C. 282(j)(5)(B), requires that a certification accompany human drug, biological, and device product submissions made to FDA. (fda.gov)
  • Diphtheria Antitoxin, Pasteur Merieux, Lyon, France), licensed in Europe and similar to the previously licensed U.S. product, is now available in the United States through an Investigational New Drug (IND) protocol through CDC. (cdc.gov)
  • An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. (clinicaltrials.gov)
  • Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. (statemaster.com)
  • RVNC ), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced its plans to move forward with two key clinical studies for its investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A. (globenewswire.com)
  • Revance is currently developing two botulinum toxin type A investigational drug product candidates. (globenewswire.com)
  • Revance's proprietary TransMTS technology enables delivery of botulinum toxin A through two novel drug product candidates, a needle-free topical form and an injectable form that may localize the drug to the site of injection resulting in a more targeted and potentially longer lasting delivery. (globenewswire.com)
  • Revance is pursuing clinical development for drug product candidates topical RT001 and injectable RT002 in a broad spectrum of aesthetic and therapeutic indications. (globenewswire.com)
  • Hovione is an international company with over 50 years' experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. (hovione.com)
  • The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. (hovione.com)
  • The AR-13503 implant marks our second foray into the retina space, with this product candidate leveraging both our scientific leadership in the creation of small-molecule kinase inhibitors for disease intervention along with our proprietary ophthalmic drug delivery platform. (yahoo.com)
  • The label for an IUO product must read, "For Investigational Use Only. (mondaq.com)
  • To qualify, the manufacturer must intend for the product to be used for research or investigational use only. (mondaq.com)
  • Statements suggesting that the product may be used in clinical investigations or for clinical diagnosis or that a clinical laboratory can validate the test using its own investigational procedures and then offer it as a laboratory developed test for clinical diagnosis. (mondaq.com)
  • Statements suggesting the product may be used for non-investigational clinical diagnosis or suggesting a use that is inconsistent with an exempt investigation. (mondaq.com)
  • Under these programs, the pharmaceutical developer also must agree to provide access to the investigational agent. (hematology.org)
  • Merck/MSD has reached a licensing agreement with Korea's Hanmi Pharmaceutical for an investigational GLP-1/glucagon dual receptor agonist for nonalcoholic steatohepatitis (NASH). (pmlive.com)
  • As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology, and medical device companies with a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. (wuxiapptec.com)
  • Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are linked to our investigational novel peptide to specifically target the Sortilin1 receptor. (biospace.com)
  • The drug blocks ALK protein kinase activity. (oncologynurseadvisor.com)
  • How does one determine if access to an investigational agent outside of a clinical trial is feasible, and if so, how is access obtained for the patient? (hematology.org)
  • In some cases, a protocol exception can be granted for a patient who otherwise does not meet eligibility criteria to allow them to receive the investigational drug as part of a clinical trial. (hematology.org)
  • CHICAGO, Ill. (March 31, 2008) A new medication that researchers had hoped would reduce the risk of arterial renarrowing after stenting has turned in a disappointing performance in a multicenter clinical trial, but the multi-reservoir stent that was used to deliver the drug is still considered promising. (bio-medicine.org)
  • Based on its mechanism of action, we believe that OMS906 will demonstrate a better safety profile and/or more convenient dosing than other drugs on the market or in development for PNH. (drugdiscoveryonline.com)
  • This program does not contain a mechanism that allows the Federal Government to force the manufacturer to provide the drug. (parentprojectmd.org)
  • The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments. (nih.gov)
  • Companies may be loath to release stock of the drug, either for fear of it being used in an uncontrolled way, competitors getting access to it, unknown safety signals coming to light or insufficient manufacturing capacity. (raps.org)
  • Overview: Access to Unapproved Investigational Drugs in the U.S. (parentprojectmd.org)
  • Routine IND Submissions: Assembling clinical, non-Clinical, CMC, etc. data for FDA drug applications. (complianceonline.com)
  • Data is collected about the impact of the drug/placebo on the patient's condition. (parentprojectmd.org)
  • IntraBio Inc. is a biopharmaceutical company with a late-stage drug pipeline including novel treatments for common and rare neurodegenerative diseases. (itbusinessnet.com)
  • Provided they add to the understanding of the investigational agents, the journal is not adverse to publishing clinical trials with negative results. (springer.com)
  • I contacted Kings Pharmaceuticals to determine the status of trials for this new drug. (rutgers.edu)
  • The Australian biotechnology company Circadian Technologies announced that its subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the FDA to initiate clinical trials of VGX-100. (ascopost.com)
  • However, clinical trials still can't begin until the company has filed the new drug application and it has been approved. (sdbj.com)
  • And perhaps most importantly, the researchers showed that such bone loss can be stopped by treating the mice with either of two investigational drugs already being evaluated in clinical trials. (wustl.edu)
  • NGM313 is an antibody targeting the beta-Klotho/FGFR1c receptor complex that could represent a new a completely new drug class for NASH and diabetes. (pmlive.com)
  • Since the discovery that a loss of CFTR function causes CF ( 1 , 2 ), there have been efforts to restore CFTR function with gene therapy or drugs to ameliorate the disease ( 8 ). (pnas.org)
  • Each issue contains original articles dealing with anticancer drug development. (springer.com)
  • Investigational New Drugs cuts across all the usual lines or subdisciplines, providing a locus for the presentation of relevant investigations and the discussion of critical questions appropriate to the entire field of new anticancer drug development. (springer.com)
  • To begin development of a drug for animal use, a company must first file an INAD with the CVM and schedule discussions with the CVM to determine the types of studies that will be used to support safety, effectiveness and manufacturing. (fiercepharma.com)
  • SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development. (biospace.com)
  • RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. (businesswire.com)
  • A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development. (nih.gov)
  • As a result, TGen Drug Development (TD2), and its investigator, Dr. Daniel Von Hoff will work with COTI to arrange an initial meeting with the FDA. (b3cnewswire.com)
  • IntraBio's management team and consultants have vast commercial experience and a successful track record of drug development in the USA and Europe. (itbusinessnet.com)
  • An hour after drug administration, the men underwent fMRI while they viewed images of high-calorie foods as well as pictures of low-calorie foods and nonfood objects. (medicalxpress.com)
  • With CDC assistance, however, miltefosine has been administered in combination with other drugs since 2009 for FLA infections as single-patient emergency use with permission from the FDA. (infectioncontroltoday.com)
  • Home PRESS RELEASES Cellectar Biosciences: Announces acceptance of investigational new drug application to evaluate I-131-CLR1404. (wisbusiness.com)
  • Chemo drugs that can often cause sores are anti-tumor and antibiotic agents like doxorubicin, or vincristine, or taxoids like docetaxel may also cause them. (cureourchildren.org)
  • Although robust responses to crizotinib are observed in lung cancers harboring ALK gene abnormalities, most of these cancers eventually become resistant to the effects of the drug. (oncologynurseadvisor.com)