Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2016
Seqirus receives FDA approval for Afluria Quadrivalent (influenza vaccine) for people 18 years of age and older
29 August 2016 - Seqirus is shipping trivalent and quadrivalent formulations of Afluria in the 2016-2017 influenza season. ...
Posted by Michael Wonder on 29 Aug 2016
Cynapsus Therapeutics receives FDA fast track designation for APL-130277 for the treatment of off episodes in patients with Parkinson’s disease
29 August 2016 - Cynapsus Therapeutics today announced that the U.S. FDA has granted fast track designation for APL-130277, a product ...
Posted by Michael Wonder on 28 Aug 2016
Amgen's shameful silence covers up reasons for FDA drug rejection
25 August 2016 - An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. FDA but the company has offered ...
Posted by Michael Wonder on 25 Aug 2016
Mallinckrodt receives FDA fast track designation for Synacthen Depot IND application
25 August 2016 - Expedites potential treatment for Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 25 Aug 2016
PhRMA and BIO give support for PDUFA VI performance goals
24 August 2016 - Both PhRMA and BIO have said they are pleased with the performance goals outlined by and ...
Posted by Michael Wonder on 24 Aug 2016
Amgen provides update on status of Parsabiv (etelcalcetide) new drug application submitted to the U.S. FDA
24 August 2016 - Amgen today announced that the U.S. FDA has issued a complete response letter for the new drug ...
Posted by Michael Wonder on 23 Aug 2016
Stemline Therapeutics receives breakthrough therapy designation from U.S. FDA for SL-401
23 August 2016 - Stemline Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to SL-401. ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 22 Aug 2016
Lilly and AstraZeneca receive FDA fast track designation for AZD3293, an investigational treatment for early Alzheimer's disease
22 August 2016 - AZD3293 is an oral potent small molecule BACE inhibitor in phase 3 development. ...
Posted by Michael Wonder on 22 Aug 2016
How Obama’s FDA keeps generic drugs off the market
19 August 2016 - A flurry of new regulations is raising production costs and reducing competition for branded drugs. ...
Posted by Michael Wonder on 22 Aug 2016
Supernus receives FDA tentative approval for expanded label of Trokendi XR to include migraine prophylaxis in adults
19 August 2016 - Supernus Pharmaceuticals today announced that the FDA has granted tentative approval to the Company's supplemental new drug ...
Posted by Michael Wonder on 22 Aug 2016
Sanofi provides update on new drug application for investigational once-daily fixed-ratio combination of insulin glargine and lixisenatide
19 August 2016 - Sanofi announced today that it has submitted updated information on the pen delivery device as part ...
Posted by Michael Wonder on 22 Aug 2016
FDA approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules CII with abuse-deterrent properties for the management of pain
19 August 2016 - Pfizer announced today that the U.S. FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release ...
Posted by Michael Wonder on 18 Aug 2016
Patents versus market exclusivity: why does it take so long to bring generics to market in the US?
17 August 2016 - It’s easy to point a finger at the US and blame the pharmaceutical companies’ lawyers for ...
Posted by Michael Wonder on 18 Aug 2016
FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
18 August 2016 - The U.S. FDA today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart ...