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RSS FeedPosted by Michael Wonder on 22 Jul 2016
Merck provides regulatory update on biologics licensing application for investigational agent bezlotoxumab
22 July 2016 - Merck today said that the U.S. FDA has requested the submission of new data and analyses from ...
Posted by Michael Wonder on 20 Jul 2016
Cerulean receives FDA fast track designation for CRLX101 for the treatment of platinum-resistant ovarian cancer
19 July 2016 - Cerulean Pharma today announced that the U.S. FDA granted fast track designation for Cerulean's lead nanoparticle-drug conjugate, ...
Posted by Michael Wonder on 20 Jul 2016
U.S. FDA approves Belviq XR, a once-daily formulation of lorcaserin for chronic weight management
19 July 2016 - Eisai Co., Ltd. announced today that the U.S. FDA has approved a new drug application for Belviq ...
Posted by Michael Wonder on 20 Jul 2016
Valeant and Progenics announce FDA approves Relistor tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
19 July 2016 - Valeant Pharmaceuticals and Progenics Pharmaceuticals, Inc. today announced that the U.S. FDA has approved Relistor (methylnaltrexone bromide) ...
Posted by Michael Wonder on 20 Jul 2016
Bristol-Myers Squibb announces availability of FDA approved Orencia (abatacept) ClickJect, a self-administered subcutaneous autoinjector, for adults with moderate to severe rheumatoid arthritis
20 July 2016 - Bristol-Myers Squibb announced today the commercial launch of the Orencia ClickJect Autoinjector, a new self-administered autoinjector for ...
Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV
18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of ...
Posted by Michael Wonder on 18 Jul 2016
Bristol-Myers Squibb announces regulatory updates for Opdivo (nivolumab) in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
18 July 2016 - Bristol-Myers Squibb Company announced today U.S. and European marketing applications to expand the use of Opdivo for ...
Posted by Michael Wonder on 18 Jul 2016
FDA accepts Scenesse clinical data package for NDA submission
18 July 2016 - Clinuvel prepares new drug application for the treatment of erythropoietic protoporphyria. ...
Posted by Michael Wonder on 18 Jul 2016
Loxo Oncology receives breakthrough therapy designation from U.S. Food and Drug Administration for LOXO-101
13 July 2016 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-101, a selective ...
Posted by Michael Wonder on 18 Jul 2016
FDA issues complete response letter for SequestOx new drug application
15 July 2016 - Elite Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter (the regarding the ...
Posted by Michael Wonder on 16 Jul 2016
Makers of Humira and Enbrel using new drug patents to delay generic versions
15 July 2016 - The best-selling drugs Humira and Enbrel have a lot in common. ...
Posted by Michael Wonder on 14 Jul 2016
Gormley’s take: road to launching ‘biosimilar’ drugs just got longer
13 July 2016 - Small companies developing lower-cost copies of expensive biotechnology drugs already faced a tough road launching their products. ...
Posted by Michael Wonder on 13 Jul 2016
Amgen biosimilar gets thumbs up from FDA panel
13 July 2016 - ABP 501 designed to be a lower-cost alternative to AbbVie’s blockbuster Humira. ...
Posted by Michael Wonder on 13 Jul 2016
Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
13 July 2016 - Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the ...