A New York drugmaker failed to follow proper procedures for sterile handling of products, the FDA said. Source: Drug Industry Daily

An appeals court dismissed Amgen’s appeal of a Delaware district court decision over Hospira’s Epogen biosimilar. Source: Drug Industry Daily

A new lawsuit alleges CVS charges insured customers more for generic drugs. Source: Drug Industry Daily

Variations in right-to-try laws passed in multiple states and at the federal level could mean compliance headaches for companies taking part in expanded access. Source: Drug Industry Daily

Former FDA commissioner Mark McClellan has put forward a proposal for value-based pricing of antimicrobials, and pricing experts tell FDAnews it has potential. Source: Drug Industry Daily

The FDA failed to follow federal law when it refused to provide exclusive marketing rights to United Therapeutics for its treprostinil formulation, branded as Orenitram, as an orphan drug, the…

President Trump said the White House is drawing up documents to officially declare the opioid addiction crisis a national emergency — two days after HHS Secretary Tom Price said the…

The FDA found numerous faults during inspections this year of the PharmaTech facility in Davie, Fla. — resulting in the agency issuing a Form 483 that described shortcomings in product-testing,…

New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Source:…

The European Medicines Agency published an internal guide on the use of multinational assessment teams for pre-authorization reviews and post-authorization extensions for new medicines. Source: Drug Industry Daily