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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
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
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