Top Regulatory News Stories – Week Ending October 13, 2017

Hi folks.  This week a landmark gene therapy to treat blindness got one step closer to FDA approval with a resounding panel endorsement.  And the FDA issued a disappointing CRL for an acute pain medication.  Here are the top regulatory news stories for pharma and biotech this week: Flexion Therapeutics secured approval from the US[…]

Top Regulatory News Stories – Week Ending October 6, 2017

After a very busy month of approvals and rejections in September, this week has been relatively quiet. Here are the top regulatory news stories for pharma and biotech this week: According to the latest FY 2017 activities report, the US FDA has approved more abbreviated new drug application (ANDA) in 2017 than any other year: […]

Regulatory Roundup: Top News Stories – Week Ending September 29, 2017

The FDA approved Eli Lilly’s Verzenio (abemaciclib) to treat adult patients who breast cancer that has progressed following prior treatment: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm Allergan received a refuse-to-file letter from the FDA for its sNDA to add an additional indication to its already-approved drug Vraylar (cariprazine). http://www.biopharmadive.com/news/allergan-hit-with-fda-refusal-to-file-letter/505726/ Janssen received a complete response letter from the FDA for its[…]

Top Regulatory News Stories – Week Ending September 22, 2017

This week the FDA approved two new molecular entities and the EC approved four new programs. Several new orphan drug designations were granted along with a fast track designation.  Here are the top regulatory news stories this week: Bayer received FDA Approval for Aliqopa™ (copanlisib) 60 mg vial for Injection in adults with Relapsed Follicular[…]

Top Regulatory News Stories – Week Ending September 15, 2017

Here are the top regulatory news stories this week: The FDA approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb):  http://www.raps.org/Regulatory-Focus/News/2017/09/14/28467/FDA-Approves-First-Biosimilar-Cancer-Treatment/ FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to[…]

Top Regulatory Affairs News Stories – Week Ending September 8, 2017

Summer is over and there has been a flurry of new regulatory news this week including new approvals and clinical holds.  Also, there were a few new partnership announcements and a major layoff at Eli Lilly.  Here is my summary of the top news stories this week: Pfizer has secured approval from the FDA for[…]