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One-third of the healthcare-related suits brought by the Department of Justice (DOJ) in 2022 concerned medical device manufacturers, pharmaceutical wholesalers and retailers, focusing particularly on violations of anti-kickback and Stark Law violations and including individuals as well as companies. Read More
An FDA advisory committee turned down Intercept Pharmaceuticals’ push for an Accelerated Approval for its fatty liver drug Ocaliva (obeticholic acid) by a 15-1 vote, but did leave the door open for full approval if data from an ongoing phase 3 trial show Ocaliva’s benefits outweigh its risks. Read More
Center for Biologics Evaluation and Research (CBER) Director Peter Marks and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni laid out their centers’ current priorities and how they’re tackling ongoing challenges in separate sessions at the FDLI Annual Conference, May 17-18. Read More
The FDA has cleared several impactful devices this week — one that can predict a dangerous pregnancy complication, one that measures heart arrhythmias for up to six years after insertion just under the skin, and one that can detect the brain plaque associated with Alzheimer’s in under five minutes. Read More
A five-year study of patients with acute coronary syndrome (ACS) revealed no notable difference in long-term clinical outcomes between those treated with titanium-nitride-oxide (TiNO)-coated stents or everolimus drug eluting stents (EES), both of which are used to widen narrow or blocked coronary arteries. Read More
Despite lingering concerns of a potential relationship to preterm birth (PTB), an FDA advisory committee supported Pfizer’s maternal respiratory syncytial virus vaccine Abrysvo (RSVpreF) to prevent severe RSV in infants by a vote of 10-4. Read More
Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products. Read More
Marketing authorization holders, wholesalers, distributors and manufacturers should have a shortage prevention plan specific to their role and strengthen the reliability and resilience of their supply chains to help prevent a drug shortage, according to a new guidance from the European Medicines Agency. Read More
The U.S. Supreme Court (SCOTUS) on Thursday struck down Amgen’s attempt to revive patents on its cholesterol medicine Repatha (evolocumab), effectively preventing the company from monopolizing an entire class of drug antibodies. Read More
The FTC and Congress were on the same drug pricing track this week as the trade commission extended an inquiry into pharmacy benefit managers’ (PBM) impact on the cost of prescription drugs and a House subcommittee unanimously voted in favor of a bill requiring hospitals to identify standard charges, including drugs. Read More
CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG.Read More