Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2018
CDER conversation: complex innovative trial designs
25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...
Posted by Michael Wonder on 28 Sep 2018
U.S. FDA approves Vizimpro (dacomitinib) for the first-line treatment of patients with EGFR mutated metastatic non-small cell lung cancer
27 September 2018 - Approval supported by data from Phase 3 head-to-head study versus gefitinib. ...
Posted by Michael Wonder on 28 Sep 2018
Lilly's Emgality (galcanezumab-gnlm) receives U.S. FDA approval for the preventive treatment of migraine in adults
27 September 2018 - Eli Lilly announced today that the U.S. FDA has approved Emgality (galcanezumab-gnlm) 120 mg injection for the ...
Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 ...
Posted by Michael Wonder on 27 Sep 2018
Statement by FDA Commissioner on preparations for the upcoming flu season and vaccinations
27 September 2018 - This week marks the official start of “flu season” for 2018-2019. ...
Posted by Michael Wonder on 27 Sep 2018
FDA budget matters: advancing innovation in digital health
26 September 2018 - When the FDA recently granted marketing authorisation for two medical apps for Apple’s new Watch, it ...
Posted by Michael Wonder on 27 Sep 2018
Blockchain hype may finally turn into reality in pharmaceuticals
26 September 2018 - U.S. law requires closer tracking of drug supply chain. ...
Posted by Michael Wonder on 27 Sep 2018
Protagonist Therapeutics announces fast track designation granted by U.S. FDA to hepcidin mimetic PTG-300
27 September 2018 - Designation applies to development for the treatment of chronic anemia in patients with beta-thalassemia. ...
Posted by Michael Wonder on 27 Sep 2018
Allergan announces FDA acceptance of supplemental new drug application for Vraylar (cariprazine)
26 September 2018 - Application seeks to expand Vraylar indication to include the treatment of bipolar depression. ...
Posted by Michael Wonder on 27 Sep 2018
Aronora's new blood clot treatment receives FDA fast track designation
26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...
Posted by Michael Wonder on 27 Sep 2018
Trade deals aren't just for manufacturing, they can lower drug prices too
26 September 2018 - Moving forward, Trump should negotiate trade agreements that ensure other countries pay their fair share for the ...
Posted by Michael Wonder on 27 Sep 2018
A perspective from our CEO: Gilead subsidiary to launch authorised generics to treat HCV
24 September 2018 - Today, Gilead announced a plan to introduce a generic version of our leading cures for hepatitis ...
Posted by Michael Wonder on 26 Sep 2018
Mylan and Novartis to FDA: where are the suffixes?
26 September 2018 - Mylan and Novartis are taking issue with the fact that the US FDA has yet to ...
Posted by Michael Wonder on 26 Sep 2018
Chinese drug maker clarifies development strategy for bringing cancer drug to the U.S. market
26 September 2018 - It’s no secret that major biopharmaceutical companies have had designs on the China drug market as a ...
Posted by Michael Wonder on 26 Sep 2018
Insulin prices could be much lower and drug makers would still make healthy profits
25 September 2018 - As prices for diabetes treatments continue to roil consumers, a new study suggests that manufacturers could ...