Top Regulatory News Stories – Week Ending December 8, 2017

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[…]

Top Regulatory News Stories – Week Ending December 1, 2017

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[…]

Top Regulatory News Stories – Week Ending November 17, 2017

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™[…]

Top Regulatory News Stories – Week Ending November 10, 2017

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[…]

Top Regulatory News Stories – Week Ending November 3, 2017

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[…]

Top Regulatory News Stories – Week Ending October 27, 2017

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[…]