Title: Drugs.com - New Drug Approvals, Description: New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals., By: Feedage Forager, ID: 893552, Grade: 97, Type: RSS091

The LiMAx® test is now commercially available in the UK. Humedics GmbH, a specialist in real-time measurement of individual liver function at bedside, today announced that the company has received the first Marketing Authorization for its diagnostic agent LiMAxetin®, which is needed to perform the LiMAx® test.. CE Mark for the LiMAx system was obtained in 2015, and application for Marketing Authorization for the diagnostic agent via the Decentralized Procedure in the UK, Austria and Germany, with Germany being the Reference Member State, was submitted in April 2016. Marketing Authorization for the diagnostic agent LiMAxetin® 4mg/ml solution for injection has now been granted by the UK healthcare authority, MHRA (Medicines and Healthcare Products Regulatory Agency), and additional marketing authorizations in Germany and Austria are expected to follow in short order.. Karsten Damgaard-Iversen, CEO of Humedics GmbH, stated: This approval is a major milestone not only for Humedics, but also for ...

Contestants in TheStreet's FDA Drug Approval Contest think well of Sarepta, Navidea and Biogen, less so about Arena, Aveo and Delcath....ARNA

You can find in Clocate.com Conferences Relevant to fda drug approval process , including, name of conference, dates, venue, price range, exhibition, description, categories and a link to a detailed page of the conference

We included all new drugs approved for use in the USA, Europe and/or Canada from 2001 to 2010, identified in a prior study.5 To be clear, this sample was limited to approvals of new molecular entities or novel biological drugs and excluded reformulations of previously approved active pharmaceutical ingredients, combination therapies of active pharmaceutical ingredients that had been approved previously, and generic drug approvals. We then used the public websites of the governing regulators for each market, the FDA, the European Medicines Agency (EMA) and Health Canada, respectively, to ensure that all drugs conformed to the original papers inclusion criteria and reconfirm FDA approval dates for all drugs unapproved by the FDA in the original data set (using a cut-off date of 1 May 2016). In addition, we updated Health Canada approval dates using the Notice of Compliance (NOC) database, which provides the most accurate timing for Canadian market access.6. Drugs first approved outside the USA ...

It has been quite a while since our last update, so this is a big one! As a reminder, this is a continuation of our new blog series to update you on recent FDA drug approvals, new indications, and other changes. You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for January - June 2020 below. If we are missing information or youd like more information about one of the noted changes, feel free to contact us ...

Pharmacia & Upjohn Has Exclusive Rights in Europe. Foster City, CA -- May 1, 1997. Gilead Sciences, Inc. (NASDAQ:GILD) announced today that it has received marketing authorization for VISTIDE (cidofovir injection) from the European Commission (EC). This authorization allows the product to be marketed in all 15 countries of the European Union as an intravenous treatment for cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a rapidly progressing viral infection that may affect a patients vision over time and may ultimately lead to blindness in patients with late-stage AIDS. The ECs action follows a December 1996 recommendation for approval from the Committee for Proprietary Medicinal Products (CPMP). Pharmacia & Upjohn (P&U) has exclusive marketing rights for VISTIDE outside the United States. In Europe, an amendment will be filed to transfer the marketing authorization from Gilead to P&U. P&U will then begin making the product available throughout the European Union on a ...

TY - JOUR. T1 - Glioblastoma survival in the United States improved after Food and Drug Administration approval of bevacizumab. T2 - A population-based analysis. AU - Johnson, Derek R.. AU - Leeper, Heather E.. AU - Uhm, Joon H.. PY - 2013/10/1. Y1 - 2013/10/1. N2 - BACKGROUND Bevacizumab received US Food and Drug Administration approval for use in recurrent glioblastoma based on promising radiographic response data, but without clear evidence that it prolongs survival. A population-based analysis was conducted to determine whether bevacizumab approval was associated with improved glioblastoma survival in the United States. METHODS Surveillance, Epidemiology, and End Results (SEER) Program data were used to compare survival of glioblastoma patients who died in 2006, 2008 (both prior to approval of bevacizumab), and 2010 (after approval of bevacizumab). RESULTS The SEER database contained 1715 patients with glioblastoma who died in 2006, 1924 who died in 2008, and 1968 who died in 2010 who met ...

In view of the controversy regarding the diabetes drug Avandia, generic name rosiglitazone, an insight to the drug approval process might be in order. The question is how can this potentially serious adverse effects, (heart attack, stroke and the potential identified increased fracture rate), just now, (after more than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat type 2, the most common form of diabetes), come to light. About 1 million Americans are

Teva seeking EU regulatory approval for anti-CGRP therapy for the prevention of migraine JERUSALEM--(BUSINESS WIRE)--Feb. 2, 2018--, European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application

DR ANTHONY MELVIN CRASTO, Worlddrugtracker, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India, in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now sSanofi, Searle India ltd, now Rpg lifesciences, etc. he is now helping millions, has million hits on google on all organic chemistry websites. His New Drug Approvals, Green Chemistry International, Eurekamoments in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published ...

DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,. Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.. Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.. His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs. He has hands on ...

A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index , the SPDR S&P Biotech ETF ...

Newron Pharmaceuticals Release: Safinamide Marketing Authorization Application (MAA) Submitted To The European Medicines Agency - read this article along with other careers information, tips and advice on BioSpace

CTI BioPharma Announces European Medicines Agency Validation of Pacritinib Marketing Authorization Application for Patients with Myelofibrosis who have Thrombocytopenia

CTI BioPharma Announces European Medicines Agency Validation of Pacritinib Marketing Authorization Application for Patients with Myelofibrosis who have Thrombocytopenia

BASEL, Switzerland, Aug. 21, 2014-- Basilea Pharmaceutica Ltd. announces today that the European Medicines Agency has accepted its isavuconazole Marketing Authorization Application for review. Ronald Scott, Basileas CEO, stated: We are very pleased with the EMAs acceptance of our MAA for review.

WASHINGTON, June 3, 2014 /PRNewswire/ -- European Medicines Agency Accepts HETLIOZ™ (tasimelteon) Marketing Authorization Application for Non-24-Hour...

Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy - News & Meetings- DuchenneXchange

Dear Diana, Thank you so very much for that information. Doesnt it seem strange and sometimes disheartening, a smaller, much smaller country than ours is so far ahead in research for certain diseases. I just cant understand it. But, I am glad that there are many countries involved in seeing and researching to goals of wellness. God Bless and thank you for that. marty LINHILLIS wrote: , , Dear All , , FYI and file , Diana , , --------------------------------------------------------------- , , Subject: SciClone Obtains First European Marketing Approval and... , Date: Tue, 21 Apr 1998 13:30:26 EDT , From: AOL News ,[email protected], , Organization: AOL (http://www.aol.com) , , SciClone Obtains First European Marketing Approval and New Drug Application , For ZADAXIN(R) Thymosin Alpha 1 , , - Deal Positions the Company for a U.S. and , , Pan European Partnering Arrangement - , , SAN MATEO, Calif., April 21 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: , SCLN) today announced the signing of an ...

Ever wonder why medications are so expensive? The FDA approval process is long and arduous for many pharmaceutical companies. The investments are massive and the time needed to conduct the appropriate rounds of testing can take years, even decades. Granted, the FDA is invested in the safety and efficacy of medication-and rightly so. Join us on a peek behind the curtain on how a drug gets approved.

The United States has the worlds most stringent standards for drug approval, and the standards are considered the benchmark worldwide

The ASCO Post article, Ibrutinib CLL Trial: Where is the Equipoise? published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the RESONATE trial. To the contrary, the FDA recognizes the needs of patients with cancer and encourages drug companies to provide earlier patient access to promising therapies.. The FDA understands the challenges of showing an overall survival improvement in CLL, given the long natural history of the disease and availability of multiple therapies. Therefore, while we may request drug companies to collect overall survival data to ensure there is no detrimental effect on overall survival and to observe any potential improvement, an improvement in overall survival is not necessary for approval in CLL.. Recent FDA approvals for a CLL indication (bendamustine [Treanda] and rituximab [Rituxan]) were based on ...

Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions: 2-day In-person Seminar event registration page. Attend Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions: 2-day In-person Seminar seminar events by ComplianceOnline near you.

Our research indicates that the FDA has exercised considerable flexibility in the approval of oncology drugs over the past decade. We found that the accelerated approval program has been used consistently in this time period, showing that sponsors interest in the program and the FDAs willingness to grant accelerated approvals have not waned. Indeed, in 2012, the FDA granted accelerated approval to five oncology drugs, matching its second-highest single-year total in the past 10 years. We also found that extension of OS, while still considered the gold standard by the FDA, is by no means required for approval in oncology. Even the conversion of accelerated approval to regular approval has frequently taken place without demonstration of an improvement in OS. Our research is consistent with a 2003 study conducted by the FDA, which found that 68% of drugs were approved on the basis of endpoints other than survival (29), as well as with a 2011 study that showed the FDAs flexibility in approving ...

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its a

PharmaWatchs blog seeks to shed light on some of the most significant policy, research, legislative and program issues related to the safety and efficacy of prescription drugs, vaccines and medical devices in Canada. They believe that the Canadian public, patients, physicians, policy analysts, researchers, academics, authors, politicians and the media have a right to know how our drug approval and monitoring system works, how it compares to other international jurisdictions, the factors influencing decision making and whether Health Canada is protecting our health and safety.. ...

Regulatory News: ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA®) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). The MAA resubmission includes the data from ERYTECHs GRASPALL 2009-06 Phase 2/3 clinical trial in children and adults with R/R ALL as well as additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was al

May 7, 2014 Santhera Pharmaceuticals announced todaythat it has re-filed with the European Medicines Agency (EMA) a Marketing Authorization Application (MAA) for Raxone® (idebenone) in the treatment of Lebers Hereditary Optic …. ...

Shares of Cempra (NASDAQ: CEMP) are down 5% mid-morning after the company said that it has withdrawn its marketing authorization application (MAA) seeking European Medicines Agency (EMA) approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults. The decision to withdraw was made based off of the Day…

CRANBURY, N.J., June 3, 2015-- Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorization application to request full approval of the oral small molecule pharmacological chaperone Galafold for Fabry patients who have amenable genetic mutations.

First-of-its-Kind Product Further Adds to Allergans Robust Eye Care Portfolio. DUBLIN, April 25, 2017 /PRNewswire/ - Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.. TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear production completed with 145 aqueous deficient dry eye adult patients.. TrueTear™ represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production, said David Nicholson, Chief R&D Officer, at Allergan. As an ...

Brain tumor news: Guilford Pharmaceuticals Receives European Marketing Authorization for Expanded Use of GLIADEL(R) Wafer - GLIADEL(R) Approved to Treat Newly-Diagnosed Patients with Malignant Glioma

Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the European Commission has granted marketing authorization for DuoResp Spiromax

HOLZKIRCHEN, Germany, April 18, 2006 - Sandoz announced today that the European Commission has granted marketing authorization for the company s recombinant human growth hormone Omnitrope ., , , , We ar...

The European Commission has granted marketing authorization for Zydelig® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable...

Alnylam Announces Filing for Marketing Authorization of ONPATTRO® (patisiran) in Brazil for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy - read this article along with other careers information, tips and advice on BioSpace

/PRNewswire/ -- Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing...

- EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumors - - Expands potential global reach of surufatinib, in addition to China where it is already launched, and in the U.S. where it is under review for marketing approval - HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., July 15, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (

droxidropa CHARLOTTE, N.C., Oct. 9, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to market Northera (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH)…

Gleevec (imatinib mesylate): Oral therapy for the treatment of chronic myeloid leukemia. New approved drug details including side effects, uses and general information.

Stivarga (regorafenib): For the treatment of gastrointestinal stromal tumor. New approved drug details including side effects, uses and general information.

This training on veterinary medicine regulations will provide attendees with a understanding of FDAs veterinary drug approval process.

This training on veterinary medicine regulations will provide attendees with a understanding of FDAs veterinary drug approval process.

TARRYTOWN, N.Y. and BERLIN, June 7, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).. The submission of VEGF Trap-Eye for EU marketing authorization represents a significant milestone in our goal to bring this potentially important new therapy to patients with wet AMD across the globe, said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.. The VEGF Trap-Eye submission is based on the positive results from two Phase 3 trials, the VIEW 1 study and the VIEW 2 study. In these ...

Get a Sample of United States Food Processing Equipment market research report from- http://www.absolutereports.com/enquiry/request-sample/10451674 No. of Report Pages: 110. Price (Single User Licence): $ 3800. Have any Query Regarding this Report? Contact us at: http://www.absolutereports.com/enquiry/pre-order-enquiry/10451674 This United States Food Processing Equipment Industry report also takes into account the past price of 2011-2015 and future price of 2016-2021 as per the supply-demand relation along with perspectives and United States Food Processing Equipment market forecasts. Additionally, the United States Food Processing Equipment Market report also discusses the data on deals (distributors) and buyers, providing a holistic insight into the supply chain and sales details of United States Food Processing Equipment Market.. Several important topics included in the United States Food Processing Equipment market research report are as follows:. ...

ZELBORAF (vemurafenib) Tablet Hoffmann-La Roche, Inc./Genentech, Inc. INDICATION: Treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation ADDRESSING UNMET NEED: ECD is slow-growing blood cancer that originates in the bone marrow; very limited life expectancies Rare cancer with no approved therapies Application of knowledge of underlying genetic characteristics of certain malignancies to other cancers…

TOKYO, June 29, 2020 -Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that Fujifilm Kyowa Kirin Biologics received manufacturing and marketing approval (MMA) in Japan on June 29 for Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1] (Product Code: FKB327).. The product is the first approved adalimumab biosimilar in Japan to AbbVie Incs Humira® (adalimumab) marketed most widely around the world. In Japan, Fujifilm Kyowa Kirin Biologics is the marketing authorization holder and Mylan EPD G.K. will be in charge of the commercialization of the product.. Fujifilm Kyowa Kirin Biologics entered into a partnership with Mylan in 2018 for the commercialization of the biosimilar adalimumab in Europe and expand it globally in 2019. To date, Mylan has commercialized the product as Hulio® in over 20 countries across Europe. Fujifilm Kyowa Kirin Biologics will continue to work obtaining marketing approvals in other countries around the world.. We are proud to be a leader by providing ...

Odevixibat A-4250, AR-H 064974 CAS 501692-44-0 BUTANOIC ACID, 2-(((2R)-2-((2-((3,3-DIBUTYL-2,3,4,5-TETRAHYDRO-7-(METHYLTHIO)-1,1-DIOXIDO-5-PHENYL-1,2,5-BENZOTHIADIAZEPIN-8-YL)OXY)ACETYL)AMINO)-2-(4-HYDROXYPHENYL)ACETYL)AMINO)-, (2S)- (2S)-2-[[(2R)-2-[[2-[(3,3-dibutyl-7-methylsulfanyl-1,1-dioxo-5-phenyl-2,4-dihydro-1λ6,2,5-benzothiadiazepin-8-yl)oxy]acetyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]butanoic acid Molecular Formula C37H48N4O8S2 Molecular Weight 740.929 AZD8294WHO 10706AR-H064974HY-109120CS-0078340D11716US9694018, 5Originator Albireo AB Developer Albireo AB; Albireo Pharma ClassAcetamides; Butyric acids; Hepatoprotectants; Small molecules; Sulfones; Thiazepines Mechanism of Action Sodium-bile acid cotransporter inhibitors Orphan Drug Status Yes - Primary biliary cirrhosis; Biliary atresia; Intrahepatic cholestasis; Alagille syndrome New Molecular Entity Yes Phase…

The attorney, Dean Lloyd, was one of six users of the Argus II retinal prosthesis who testified in front of a Food and Drug Administration (FDA) ophthalmic devices panel on September 28. They all urged its members to recommend marketing approval in the U.S. for the device.. I am happy to report that the panel did, in fact, vote to recommend marketing approval, and I think the heartfelt testimonies of those who used the Argus II in clinical trials helped move the panel toward that decision. The panels recommendation bodes well for final FDA approval, which will hopefully arrive in the not-too-distant future.. While Dean testified pragmatically - no surprise, he is a lawyer, after all - others who spoke about their experiences with the Argus II were quite emotional. For example, Cathy Blake, also blind from RP, became tearful as she explained how one of the most important benefits of using the Argus II is the ability to see movement.. What I really love most about the device is I can tell if ...

By James DeGiulio -- Choosing the appropriate regulatory pathway for biologics drug approval by the U.S. Food and Drug Administration has historically not been a strategic decision to be made by drugmakers. In most cases, only one pathway is applicable to the particular drug product. The traditional NDA 505(b)(1) path is for new drugs, the abbreviated new drug application (ANDA) path is for generics, and the 505(b)(2) path covers the middle ground, including reformulations and combinations of existing drugs. Most new biologic drugs today are approved via a Biological License Application (BLA) rather than an NDA, and are subject to...

In addition to the application of Iluvien for the treatment of DME licensed to Alimera, pSivida is independently developing the product for the treatment of posterior uveitis. The FDA recently cleared the companys Investigational New Drug (IND) application to treat posterior uveitis with its injectable, sustained-release micro-insert, permitting pSivida to move directly to two Phase III trials under which it would enroll a total of 300 patients. However, the FDA approval of Iluvien for DME opens up the potential for pSivida to seek FDA approval on Medidur for uveitis with only one Phase III clinical trial, similar to what occurred with Allergans Ozurdex and its FDA approvals. The FDA is allowing pSivida to reference much of the data, including the clinical safety data, from the clinical trials of Iluvien for DME previously conducted by Alimera. Under the terms of its collaboration agreement with Alimera, pSivida has joint ownership of, and reference rights to, all clinical data and regulatory ...

Last year, more new drugs reached the market than in any year since 1996. But many have six-figure price tags for a years worth of treatment and deliver only incremental health benefits. What does this mean for patients and the pharmaceutical industry? The cover story in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society, parses the 2015 crop of therapies and who might benefit.

Remedy Health Media: About Remedy Health Media , Contact Remedy Health Media , Terms of Use , Privacy Policy. TheBodyPRO.com is a service of Remedy Health Media, LLC, 750 3rd Avenue, 6th Floor, New York, NY 10017. TheBodyPRO.com and its logos are trademarks of Remedy Health Media, LLC, and its subsidiaries, which owns the copyright of TheBodyPRO.coms homepage, topic pages, page designs and HTML code. General Disclaimer: TheBodyPRO.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBodyPRO.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.. ...

This safety information is specific to the current U.S. approved indication, which is based on Phase 2 studies. Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events (5 patients), end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.. Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months and conduction abnormalities uncontrolled by medications were not ...

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.. FDAs approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease, said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research. Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.. Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as eczema, which is a general term for several types of inflammation of ...

EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older. The European Commission (EC) is expected to make a final decision on the companys Marketing Authorization Application (MAA) by the end of the year.. Read this article ...

According to a press release issued on Wednesday, Turing Pharmaceuticals will be pushing several new drug candidates for toxoplasmosis into preclinical development. The company says the small molecular compounds are a result of Turings toxoplasmosis research efforts, with the drug candidates reportedly offering improved potency and specificity over currently-available treatments, in animal models.. Turing reports that it has started safety studies for the compounds in support of an eventual filing of an Investigational New Drug Application (IND), as part of the US Food and Drug Administrations (FDA) drug approval process. According to a statement, the company anticipates that clinical trials for the experimental drugs will begin in the second half of 2017.. Theres a definitive need for new and improved therapies against toxoplasmosis, said Dr. Eliseo Salinas, Turings President of R&D. Current therapies target a protein family that is required by both the parasite and its human host. ...

The FDA on October 19, 2016, granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons, or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment. - Year:2016

The European Medicines Agency (EMEA) published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation. They give guidance on quality, non-clinical and clinical issues. The product class specific annexes to the guideline on non-clinical and clinical issues give guidance for certain classes of medicines: those containing insulin, containing somatropin and those containing recombinant granulocyte-colony stimulating factor (an annex for medicines containing epoetin will also be available soon). The guidelines come into effect from June 1, 2006. EMEA has also published two new concept papers. The first is a concept paper on comparability of biotechnology-derived medicinal products after a change in the manufacturing process (non-clinical and clinical issues). The second is a concept paper on immunogenicity assessment of therapeutic proteins. The guideline on ...

May 31, 2016 (BBC) – Regulators have given one of the world’s largest drug companies approval to sell a new gene therapy. The treatm...

FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

New Republic, December 14, 2016. Last week, the Senate followed the House in passing the 21st Century Cures Act. Though this bill has been lauded by liberals for providing much-needed funds for medical research, its real impact will be elsewhere. Whereas drug approval traditionally required the demonstration of real clinical benefit in a randomized clinical trial, under the Act drug firms will increasingly be able to rely on flimsier forms of evidence for approval of their therapies (incremental steps in this direction, it is worth noting, have already occurred). The Act, by reconfiguring the drug regulatory process, lowers the standards for drug approval - a blessing for drug makers, but an ill omen for public health.. In the Senate, a grand total of five senators - including Bernie Sanders and Elizabeth Warren - voted against it. The media, meanwhile, has for the most part done a poor job dissecting its actual contents. As a result, few now realize how detrimental the act is likely to be for ...

On May 23, 2012, an FDA advisory panel narrowly recommended against expanding the use of the Johnson & Johnson drug Xarelto on Wednesday, citing concerns that bleeding outweighed evidence that the drug helped reduce the risk of blood clots in patients with serious heart problems. Xarelto is an anticoagulant drug that was approved in 2011 to prevent blood clots in patients undergoing knee or hip replacement surgery and for people with atrial fibrillation. Johnson & Johnson is seeking to expand the use of the drug to patients with acute coronary syndrome (ACS). Current treatments for the condition include use of aspirin plus clopidogrel (Plavix).. Several members of the advisory panel were concerned about the idea of adding a third drug to the standard treatments, and said the benefits of doing so did not outweigh the risks. More than 15 percent of the studys participants had dropped out, calling into the question the breadth of the data acquired. As reported in the media, in a clinical trial of ...

Personal genetics company 23andMe announced it has applied for U.S. Food and Drug Administration approval for seven of its genetic tests. The company hopes that FDA approval will increase consumer confidence and interest in its tests, and ultimately feed into its goal of crowdsourcing human genetic information for medical research. But it could be a risky move-if regulatory approval includes a requirement for a medical providers involvement, that could interfere with the companys direct-to-consumer model, at least for some of its tests. Thats the part where we are going to have to see how it plays out, says Linda Avey, a cofounder of 23andMe who has since left the company. The direct-to-consumer model was a founding principle of 23andMe, which emphasizes individual participation in health and medicine, says Avey. ...

Copyright c 1996 Elsevier Science B.V. All rights reserved. The marketing authorization for a new medicinal product is based on the scientific assessment of its quality, safety and efficacy. The marketing authorization application MAA & rpar ; which covers all the relevant documentation can be filed in the EU via different application...

Escitalopram, like other SSRIs, has been shown to affect sexual functions causing side effects such as decreased libido, delayed ejaculation, genital anesthesia,[17] and anorgasmia.[18][19]. An analysis conducted by the FDA found a statistically insignificant 1.5 to 2.4-fold (depending on the statistical technique used) increase of suicidality among the adults treated with escitalopram for psychiatric indications.[20][21][22] The authors of a related study note the general problem with statistical approaches: due to the rarity of suicidal events in clinical trials, it is hard to draw firm conclusions with a sample smaller than two million patients.[23]. Escitalopram is not associated with significant weight gain. For example, 0.6 kg mean weight change after 6 months of treatment with escitalopram for depression was insignificant and similar to that with placebo (0.2 kg).[24] 1.4-1.8 kg mean weight gain was reported in 8-month trials of escitalopram for depression,[25] and generalized anxiety ...

Sabinsa Corporation is a manufacturer, supplier and marketer of herbal extracts, cosmeceuticals, minerals, dietary supplements and specialty fine chemicals for the nutritional, cosmetic, pharmaceutical and food industries

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Have Any Query? Ask Our Expert for EMEA Electronic Nose Market Report @ http://www.marketreportsworld.com/enquiry/pre-order-enquiry/10327296 Detailed TOC of EMEA Electronic Nose Market Research Report:. Chapter 1 Market Overview:. 1.1 Product Overview and Scope of EMEA Electronic Nose. 1.2 Market Analysis by Type. 1.3 Market Analysis by Applications. 1.4 Market Analysis by Regions. 1.4.1 North America (USA, Canada and Mexico). 1.4.2 Europe (Germany, France, UK, Russia and Italy). 1.4.3 Asia-Pacific (China, Japan, Korea, India and Southeast Asia). 1.4.4 South America, Middle East and Africa. 1.5 Market Dynamics. 1.6 Market Opportunities. 1.7 Market Risk. 1.8 Market Driving Force. 1.9 Market Strategies. Chapter 2 Manufacturers Profiles:. 2.1 Company Name. 2.1.1 Business Overview. 2.1.2 Company Name Sales, Price, Revenue, Gross Margin and Market Share. Chapter 3 Global EMEA Electronic Nose Market Competition, by Manufacturer:. 3.1 Global EMEA Electronic Nose Sales and Market Share by ...

Fast Track designation confers some or all of the following benefits: more frequent meetings with FDA to discuss the drugs development plan and ensure collection of appropriate data needed to support drug approval, more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. This Fast Track status granted by the FDA for CVac comes in addition to the Orphan Drug Designation previously granted by the FDA in September 2010. Orphan Drug Designation is intended to provide incentives to encourage companies to pursue cures and treatments for rare ...

The FDA has granted a regular approval to enfortumab vedotin-ejfv and has expanded the agents indication to include adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have received 1 or more prior lines of therapy.

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 ...

NEW YORK, April 26, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Companys New Drug Application (NDA) for AXS-05 for the treatment of major depressive disorder (MDD), and has granted the application Priority Review. AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.. Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. In general, the FDAs Priority Review designation accelerates the review time from 10 months to a goal of six months from the date of acceptance of the filing. The FDA has set a ...