Blog
RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 18 Aug 2016
Portola Pharmaceuticals receives complete response letter from FDA for biologics license application for AndexXa (andexanet alfa)
17 August 2016 - Portola Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 17 Aug 2016
Esketamine receives breakthrough therapy designation from U.S. Food and Drug Administration for major depressive disorder with imminent risk for suicide
16 August 2016 - FDA action marks second breakthrough therapy designation for intranasal esketamine, highlighting its potential as treatment for patients ...
Posted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...