Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2016
Generic Crestor wins approval, dealing a blow to AstraZeneca
20 July 2016 - The FDA said Wednesday that it had approved generic versions of the blockbuster cholesterol-lowering pill Crestor, rejecting ...
Posted by Michael Wonder on 22 Jul 2016
Valeant Pharmaceuticals receives complete response letter from the FDA
22 July 2016 - FDA letter related to current good manufacturing practice at Bausch & Lomb facility. ...
Posted 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 22 Jul 2016
Highlights from the CHMP 18-21 July 2016 meeting
22 July 2016 - Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection. ...
Posted by Michael Wonder on 22 Jul 2016
Two new medicines for advanced kidney cancer
21 July 2016 - Cabometyx and Kisplyx provide additional treatment options for patients with unmet medical need. ...
Posted by Michael Wonder on 22 Jul 2016
Pediapharm receives Health Canada approval for rupatadine
21 July 2016 - Pediapharm is very pleased to announce Health Canada's approval of rupatadine fumarate (10 mg tablets and 1 ...
Posted by Michael Wonder on 22 Jul 2016
Mylan and Biocon announce regulatory submission for proposed biosimilar pegfilgrastim accepted for review by European Medicines Agency
21 July 2016 - Mylan and Biocon Ltd. announced today that the EMA has accepted for review, Mylan's marketing authorization application ...
Posted by Michael Wonder on 21 Jul 2016
Proposals to revise guidance on first-in-human clinical trials
21 July 2016 - Comments invited on a concept paper on changes intended to support best practices. ...
Posted by Michael Wonder on 21 Jul 2016
Health Canada approves Invokamet for the treatment of adults with type 2 diabetes mellitus
20 July 2016 - Janssen announced today that Invokamet, a twice daily fixed-dose therapy combining Invokana (canagliflozin) and metformin hydrochloride into ...
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
AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of type 2 diabetes mellitus
19 July 2016 - AstraZeneca today announced that the European Commission has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type ...
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
EMA publishes EPAR for Zinbryta (daclizumab)
19 July 2016 - The EMA has published an EPAR for Biogen's Zinbryta. ...