Regulatory Roundup: Top News Stories – Week Ending May 26, 2017

I am posting this week’s regulatory update a day early since our office will be closed tomorrow for the holiday weekend.  Only one new molecular entity was approved this week, along with a couple of new indication approvals.

The FDA approved Kevzara (sarilumab), a treatment of rheumatoid arthritis which was co-developed by Sanofi and Regeneron.  Full Story Here

Merck’s Keytruda was granted two bladder cancer approvals by the FDA.  Keytruda, which is also approved for lung cancer, is being developed for more than 30 tumor types in nearly 500 clinical trials, according to Merck. Full Story Here

Amgen faced a setback this week regarding their osteoporosis program which is pending FDA approval. New safety data from late-stage clinical trials indicates a higher rate of serious heart-related side effects.

Spark Therapeutics completed its BLA submission with the FDA for its experimental gene therapy for patients with rare inherited blindness.  If approved, voretigene neparvovec, could be the first U.S. treatment that uses genes as medicine. Full Story Here

Genentech’s Actemra (tocilizumab) has been approved by the FDA for the treatment of giant cell arteritis (GCA). GCA (also known as temporal arteritis) affects an estimated 228,000 people over the age of 50 in the U.S. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke. Full Story Here

Sage Therapeutics received fast track designation for their experimental depression drug.  Full Story Here

This week Celgene announced positive results from the second Phase III trial of ozanimod in Patients with Relapsing Multiple Sclerosis.  They are expected to file an NDA to the FDA by the end of 2017. Full Story Here

Aerie Pharmaceuticals reported positive Phase 3 results for its combination product candidate for glaucoma. They expect to file their NDA in the first half of 2018:  Full Story Here

Puma Biotech received FDA advisory committee support for Neratinib, for the treatment of some breast cancers: Full Story Here

GW Pharmaceuticals published positive Phase 3 data for its cannabis-based epilepsy drug and they plan to file for FDA approval shortly: Full Story Here

So far in 2017 FDA has approved 21 new molecular entities. You can see the full list of companies that received approvals and the specific indications at FDA NME Approvals 2017

In other news… Bioverativ (which was recently spun off from Biogen) is acquiring rare disease drugmaker True North Therapeutics Full Story Here

I hope you all have a wonderful Memorial Day weekend!


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