We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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 Medicare Part D high cost drugs, the company was also filing a motion for summary judgment for the courts to declare the IRA unconstitutional. Read More
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 safety history. Read More
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. Read More
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 lack of consistent data and ill-defined biomarkers. Read More
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 Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More
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 804 importation program (SIP) proposal to import cheaper drugs from Canada. Read More
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 block generic competition — says a new report from the Initiative for Medicines, Access and Knowledge (I-MAK). Read More
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 to FDAnews Wednesday. Read More
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. Read More