Amgen asked a federal court to declare that its newly approved biosimilar Mvasi does not violate 27 patents Genentech holds on Avastin, the reference cancer drug Genentech is trying to…
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Source: Drug Industry Daily
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Source: Drug Industry Daily
California Gov. Jerry Brown (D) signed price transparency measures into law that require drugmakers to notify purchasers ahead of large increases and to justify those increases to the state. Source:…
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Source: The GMP Letter
Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Source: The GMP Letter
The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems. Source: The GMP Letter
The FDA issued flagged six device manufacturers for issues ranging from responses to customer complaints to record-keeping. Source: The GMP Letter
The FDA issued warning letters to five device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations.…
With the recall of 465,000 Abbott pacemakers deemed at risk of getting hacked — marking the first ever device recall for a cybersecurity issue — it’s time for a deeper…