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The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
A drug pricing watchdog was rebuffed on Aug. 25 in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
The FDA released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released Sunday. Read More
Amarin is asking a New York federal court judge to halt further litigation with the FDA over off-label promotion of its cholesterol-lowering drug Vascepa until Oct. 30, while the parties discuss possible settlement options. Read More
Bristol-Myers Squibb has agreed to pay up to $1.25 billion to acquire Promedior and its lead asset, PRM-151 — currently in Phase 2 development for the treatment of idiopathic pulmonary fibrosis and myelofibrosis. Read More