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The UK government aims to stay up-to-date with EU changes for clinical trial procedures amid uncertainties over next March’s implementation of Brexit. Read More
The FDA’s Arthritis and Drug Safety Committee and the Risk Management Advisory Committee voted 15 to 5, with a single abstention, that Pfizer’s PRECISION trial, which compared Celebrex (celecoxib) to ibuprofen and naproxen, demonstrated comparable cardiovascular safety. Read More
The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Read More
In a landmark decision for patent law, and to the disappointment of some drug makers, the U.S. Supreme Court upheld the legality of inter partes reviews, preserving a method that makes it easier to challenge and invalidate dubious patents. Read More
The committee approved several amendments to the bill, including one from Sen. Bill Cassidy (R-La.) clarifying reporting requirements to ensure that treatment for addiction and mental health care is reimbursed similarly to traditional medical care. Read More
Adding to the already numerous lawsuits, the Teamsters union sued opioid manufacturers, distributors and pharmacy benefit managers in the U.S. District Court for the Northern District of Ohio over their alleged role in the addiction crisis. Read More
The Senate Committee on Health, Education, Labor and Pensions unanimously advanced the Opioid Crisis Response Act (S. 2680) Tuesday but voted down an amendment to impose tough penalties on drugmakers. Read More
Generic drug approvals were in the spotlight during remarks by FDA Commissioner Scott Gottlieb before a Senate appropriations subcommittee on the FDA’s fiscal year 2019 budget request. Read More