Around the same time AstraZeneca was signing its price negotiation agreement with CMS for its diabetes drug Farxiga, which is included in the Inflation Reduction Act’s (IRA) first list of…
Royal Philips has denied reports that it withheld evidence of sleep and respiratory ventilator product malfunctions for more than a decade, arguing that recent media articles mischaracterize the Amsterdam-based devicemaker’s…
The FDA has provided further direction on developing therapies for graft-versus-host diseases (GvHD), technical considerations for devices with physiologic closed-loop controls, electronic De Novo requests, and breakpoints in labeling for…
Our coverage includes EMA’s revocation of conditional marketing authorization for Blenrep, FDA approvals for Pfizer’s Bosulif and Viatris/Ocuphire Pharma Ryzumvi, and the FY 2024 priority review voucher fee rate. Source:…
Despite strong testimony and comments from patients and clinicians, the FDA advisory committee reviewing NurOwn, an investigational treatment for amyotrophic lateral sclerosis (ALS), voted against recommending the drug, citing a…
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual…
PhRMA, the Partnership for Safe Medicines (PSM), and the Council for Affordable Health Coverage (CAHC) have sent a 10-page letter to the FDA requesting that the agency deny Florida’s Section…
Drugmakers have netted a whopping $185 billion from just four mega-blockbusters by leveraging patent thickets — the filing of overlapping patents to artificially extend a drug’s intellectual property protections to…
Bristol Myers Squibb (BMS) has struck an agreement with CMS to negotiate the price of its blood thinner medication Eliquis (apixaban) ahead of the Oct. 1 deadline, the drugmaker confirmed…
The European Parliament and the European Medicines Agency (EMA) have agreed upon a regulation — updating a newly 20-year-old model — to modernize and simplify application fees the EMA collects.…