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I am posting my regulatory news blog early since I will be out of the office tomorrow. Here are the top regulatory news stories this week: The U.S. FDA approved Mylan’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin. This is the eighth biosimilar to be approved by the FDA: https://www.reuters.com/article/us-mylan-nl-fda/fda-oks-mylans-biosimilar-of-roche-cancer-drug-herceptin-idUSKBN1DV5BI Sunovion received FDA[…]
Hi folks, I’m publishing my blog a day early since I will be out of the office tomorrow. Here are the top regulatory news stories for this week: Scott Gottlieb, the commissioner of the Food and Drug Administration, announced plans to speed generic versions of treatments that combine a drug and a device: https://www.forbes.com/sites/matthewherper/2017/11/28/fda-boss-aims-to-close-epipen-loophole/#4af7e7fe39f9 According[…]
This has been a big week with multiple approvals by the FDA for new molecular entities along with the approval of the first digital pill and a couple of supplemental approvals. Here is my summary of the top regulatory news stories for pharma and biotech this week: Ultragenyx announced that the FDA has approved MEPSEVII™[…]
Hi folks. I am posting a day early since I will be out of the office tomorrow. The big news this week was the approval of a new molecular entity for Merck along with new indication approvals for both Genentech and Keryx. Here is my summary of the top stories this week: Merck announced that[…]
This week saw the approval of two new molecular entities by the FDA along with a strong advisory panel recommendation. Here is my recap of the top regulatory news stories to follow: Valeant Pharmaceuticals has won U.S. FDA approval for its glaucoma drug Vyzulta ending a more than two-year effort to bring the drug to[…]
Hi folks, here are the top regulatory news stories to follow this week: GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, Shingrix: https://www.reuters.com/article/us-usa-fda-gsk/gsk-wins-u-s-shingles-vaccine-approval-uk-nod-for-gene-therapy-idUSKBN1CS0TU The FDA expanded its approval for Alexion’s blood-disorder drug Soliris to include treatment for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris was[…]
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[…]
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: […]
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[…]
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[…]