This past week has been busy with lots of big announcements in the industry. Here are some of the top stories which are creating buzz in the regulatory world:
The FDA approved Takeda/Ariad’s ALUNBRIG for the treatment of non-small cell lung cancer. This is great news for Takeda who recently completed their purchase of Ariad. ALUNBRIG is an orphan drug approved under the FDA’s accelerated pathway. Full article here.
BioMarin‘s Batten disease drug BRINEURA was also approved by the FDA this week. They will be pricing the ultra-rare disease drug at a cost of approximately $700,000 per year. Full article here.
Sarepta Therapeutics CEO Ed Kaye will step down but remain with the company as an advisor. And now rumors are swirling that Sarepta could be acquired by Sanofi. This comes just six months after Sarepta’s Duchenne Muscular Dystrophy program was approved by the FDA. Full article here.
Marathon Pharmaceuticals is winding down operations after selling its recently approved Duchenne Muscular dystrophy drug to PTC. Full article here.
OncoMed will reduce its workforce by approximately 50 percent, resulting in 64 remaining full-time employees. In addition to the bad news we saw earlier in April, OncoMed got another dose of bad news last week from negative top line results for a Phase 2 trials. Full article here.
The FDA approved Novartis’s Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). Full article here.
So far in 2017 the FDA has approved 16 new molecular entities. You can see the full list of companies that recieved approvals and the specific indications here.
This is a weekly recap of selected regulatory news stories. You can read our other blogs, see our recent job postings, and learn more about us at www.dennispartners.com