Here are the top nine regulatory news stories this week:
The European Commission (EC) approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-based therapy. Full Story Here
Gilead Sciences plans to submit a new triple combination HIV therapy for FDA approval based upon four successful Phase 3 studies: Full Story Here
The FDA granted Fast Track Designation to ProQR’s QR-110 for treatment of patients with Leber’s Congenital Amaurosis Type 10, one of the most prevalent forms of gene-related blindness in children worldwide. Full Story Here
Alkermes has secured approval from the FDA for a two-month dosing option of Aristada to treat schizophrenia. The FDA originally approved Aristada in October 2015. Full Story Here
After several failed attempts at getting approval for its DMD drug, PTC Therapeutics landed an advisory committee meeting for September. Full Story Here
Pfizer received FDA fast track designation for Tafamidis for transthyretin cardiomyopathy Full Story Here
AbbVie’s rheumatoid arthritis drug upadacitinib succeeded in phase 3 study. Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing, and it is also being investigated to treat Crohn’s disease, ulcerative colitis and atopic dermatitis. Full Story Here
In a dramatic first, the Food and Drug Administration is requesting that Endo Pharmaceuticals remove their opioid drug, Opana ER, from the market because of its potential for causing abuse. Full Story Here
The FDA accepted Synergy Pharmaceuticals’ sNDA for Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation. The PDUFA date is January 24, 2018. Trulance has already been approved by the FDA for the treatment of adults with chronic idiopathic constipation Full Story Here
In other news…
Mersana Therapeutics has filed for an initial public stock offering that would help fund clinical trials for the company’s experimental treatment for breast cancer. Full Story Here
Cambridge-based biotech Aileron Therapeutics has also filed for a $69 million IPO Full Story Here
Eil Lilly entered a $55 million collaboration with the Swiss biotech KeyBioscience on a class of dual amylin-calcitonin receptor agonist drugs aimed at amping up insulin sensitivity and spurring weight loss for diabetics. Full Story Here
Valeant is selling its iNova Pharmaceuticals business for $930 million in an attempt to reduce their debt Full Story Here
This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com