Regulatory Roundup: Top News Stories – Week Ending June 9, 2017

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

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