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...
GTX-102 for Angelman syndrome is cleared for clinical trials following the FDAs activation of its investigational new drug application.
The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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 ...
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OXFORD, UK / ACCESSWIRE / March 13, 2019 / IntraBio Inc., a late-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA)
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 ...
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...
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 24, 2004--Amgen Inc. (Nasdaq:AMGN), the worlds largest biotechnology company, today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for palifermin, a first-in-class investigational compound in development by Amgen for oral mucositis (mouth sores). The potential therapeutic indication is to reduce the incidence, duration and severity of oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy, with or without irradiation, followed by a bone marrow transplant.. Approximately 11,000 Americans with hematologic malignancies, including non-Hodgkins lymphoma, Hodgkins disease, leukemia and multiple myeloma, undergo bone marrow transplants each year.. The BLA was submitted under the FDAs Fast Track designation program, which is designed to expedite FDA review of an investigational therapy for an unmet medical need. If approved, palifermin will be the first ...
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.. The US FDA sBLA submission acceptance is an important milestone for Imfinzi in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for patients with this earlier stage of lung disease is active monitoring following concurrent chemoradiation.. The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint. Detailed results of the PACIFIC trial, ...
MALVERN, Pa., Nov. 7, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. Submits Supplemental Biologics License Application to the FDA for XIAFLEX® for...
Basel, 17. Januar 2019. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the companys supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. The FDA is expected to make a decision on approval by 2 September 2019.. "We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible," said Sandra Horning, MD, Roches Chief Medical Officer and Head of Global Product Development. "Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival ...
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced completing the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment o...
CAMBRIDGE, Mass., Jan. 04, 2016-- Vericel Corporation, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for MACI™, the company s investigational autologous cellular product...
INCHEON, Republic of Korea & JERUSALEM--(BUSINESS WIRE)--Jul. 31, 2017-- Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: T, Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Herceptin® (trastuzumab)
Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration (
Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks PR Newswire LEIDEN, The Netherlands, November 27, 2017
Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Dr
By Phyllis Griffin Epps The Food and Drug Administration (FDA) is finalizing guidelines that would recommend the use of racial and ethnic categories in clinical drug trials and the submission of data regarding the safety and efficacy of pharmaceutical products subject to FDA approval. The draft guidance, titled Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials (http://www.fda.gov/OHRMS/DOCKETS/98fr/03-2162.pdf ) and issued in January 2003, has as its premise the 1998 final rule of Investigational New Drug Applications and New Drug Applications (the Demographic Rule ). 63 Federal Register 6854 (Feb. 11, 1998) (codified at 21 CFR 312.33(a) (2) and 21 CFR 314.50(d) (5)). A commentary on the Demographic Rule, which requires sponsors of New Drug Applications to include an analysis of data according to demographic subgroups, the draft guidance recommends use of the categories developed by the Office of Management and Budget ( OMB ) to standardize the collection and use of ...
Investigational VariZIG is produced by Cangene Corporation (Winnipeg, Canada) and is distributed by FFF Enterprises (Temecula, California). An expanded access protocol under the IND application enables use of investigational VariZIG for patients who meet the protocols enrollment criteria and who choose to participate. The expanded access protocol has received central institutional review board (IRB) approval. With this central IRB review and approval, FDA does not require an additional approval by the IRB at the treatment site. However, some institutions might require that the institutions IRB be notified before the institution or its physicians participate in a study reviewed by a central IRB. In such cases, notification and any local IRB review may take place before a patient who needs the investigational product is identified. However, if a patient who needs the investigational product is identified before any required local IRB review has taken place, the investigational product may be ...
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.
SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melintas NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48-to-72 hours. In addition, Baxdela met the primary endpoint, the investigator ...
EWING, N.J., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced that the New Drug Application (NDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, has been accepted for standard review by the U.S Food and Drug Administration (FDA). QST was developed to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017, ten months from the official NDA submission. The PDUFA date is the target date for the FDA to complete its review of the NDA.. "The FDAs acceptance of the QuickShot testosterone NDA is an important start to the review process and marks another significant milestone for our Company," said Robert F. Apple, President and Chief Executive Officer. "We continue to believe QST could be an excellent treatment option for men with ...
CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) and Ionis (NASDAQ:IONS) today announced that Biogen has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of nusinersen, an investigational treatment for spinal muscular atrophy (SMA). Biogen has also applied for Priority Review which, if granted, would shorten the review period of nusinersen following the Agencys acceptance of the NDA.
Anacor Pharmaceuticals Announces That It Has Submitted a New Drug Application to the FDA for Tavaborole PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals (NAS: ANAC) announced today
NEW YORK & SAN DIEGO-- Pfizer Inc. (NYSE: PFE) and Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013. BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. BZA/CE has been studied in a Phase III clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 postmenopausal women and assessed the safety and efficacy of BZA/CE for the treatment of moderate-to-severe VMS and VVA associated with ...
Dec 17, 2012 - Antares Pharma, Inc. (NASDAQ ATRS) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
Ultragenyx Announces Submission of New Drug Application to FDA for UX007 (triheptanoin) for Treatment of Long-Chain Fatty Acid Oxidation Disorders - - Novato (California)
PRINCETON, N.J. & FOSTER CITY, Calif.--(BUSINESS WIRE)--April 27, 2006--Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of a product that combines the anti-HIV medications Sustiva(R) (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, in a once-daily single tablet regimen. Truvada itself is a fixed-dose product that contains two of Gileads anti-HIV medications, Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R) (emtricitabine), in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete Highly Active Antiretroviral Therapy (HAART) regimen in a single once-daily tablet, intended for the treatment of HIV-1 infection in adults as a complete regimen or in ...
AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) announced that it has submitted a New Drug Application (NDA) under section 505(b)(2) with the U.S. Food and Drug
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
Drug developer Isis Pharmaceuticals Inc. and partner Genzyme announced Tuesday that the U.S. Food and Drug Administration has approved their new drug application for Kynamro, clearing the way for Isis ...
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration has advised the Company that its New Drug Application (NDA) for crofelemer 125 mg tablets, for the proposed indication of......SLXP
SAN FRANCISCO, Nov. 19, 2013 /PRNewswire/ -- New Drug Application For Naloxegol Accepted By United States Food And Drug Administration.
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) for apomorphine sublingual film (APL-130277; Sunovion, Marlborough, M
KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company's investigational insomnia medicine, has been accepted for standard......MRK
Cephalon, Inc. (Nasdaq: CEPH) today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market
Otsuka Pharma Release: FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena (Aripiprazole) For The Treatment Of Bipolar I Disorder - read this article along with other careers information, tips and advice on BioSpace
Array BioPharma Announces FDA Acceptance For Review Of Binimetinib And Encorafenib New Drug Applications For Patients With Advanced BRAF-mutant Melanoma - read this article along with other careers information, tips and advice on BioSpace
Pfizer Announces FDA Accepts Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
* CHEMOCENTRYX SUBMITS NEW DRUG APPLICATION TO THE U.S. FDA FOR AVACOPAN IN ANCA-ASSOCIATED VASCULITIS Source text for Eikon: Further company coverage:
Certara congratulates MDGH on submission of the moxidectin new drug application for the treatment of river blindness (onchocerciasis), a debilitating tropical disease.
Shire plc announces that its partner in Japan, Shionogi has submitted a New Drug Application (NDA) for INTUNIV® for ADHD in adults.
Healthcare Sales & Marketing Network: AMAG Submits Supplemental New Drug Application to FDA for Makena(R) (Hydroxyprogesterone Caproate Injection) Auto-Injector for Subcutaneous Use
Healthcare Sales & Marketing Network: AMAG Submits Supplemental New Drug Application to FDA for Makena(R) (Hydroxyprogesterone Caproate Injection) Auto-Injector for Subcutaneous Use
MONEY FM 89.3 Innovent and Eli Lilly Announce Acceptance of a Supplemental New Drug Application of TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum as First-Line Therapy in Squamous Non-Small Cell Lung Cancer in China - We are bringing Money FM 89.3 near you in Singapore.
A Phase II clinical trial, testing the safety and effectiveness of an investigational new drug (IND) to aid in the surgical removal of malignant brain tumors, will soon get underway at Emory University Hospital Midtown and Winship Cancer Institute of Emory Univ
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. A total of 940 patients intolerant of or unresponsive to trimethoprimsulfamethoxazole were enrolled from private practices, clinics, and institutional HIV treatment centers in the United States. Demographics data and the history and severity of PCP were collected at enrollment.
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 ...