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…
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…
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…
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…
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…
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…
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. Source: Drug Industry…
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…
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…
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…