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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
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
The Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI) have partnered to assess digital health technologies (DHTs) against the standards that devicemakers should meet when generating early studies for their products. Read More
The FDA issued a complete response letter (CRL) to Coherus Biosciences on its BLA for a biosimilar of Neulasta (pegfilgrastim) solely due to an ongoing review of inspection findings at a third-party filler, the company said. Read More
The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER. Read More
The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting. Read More