Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by Hospira. Read More
A White House commission on opioid abuse, established in March by executive order, delivered its initial set of recommendations to President Trump, urging him to declare an immediate, national state of emergency. Read More
Pharmaceutical and medical device companies will not get tax breaks after the Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning, with nays from Sens. Lisa Murkowski (R-Alaska), Susan Collins (R-Maine) and John McCain (R-Ariz.). Read More
A Pennsylvania federal court ruled that 11 generic manufacturers, including several subsidiaries of Teva Pharmaceuticals, must answer to a class-action lawsuit claiming they violated state consumer protection and unfair trade practice laws by inflating their prices. Read More
Celgene reached a civil settlement with the Department of Justice and 28 states, as well as Washington D.C. and the city of Chicago, agreeing to pay $280 million to resolve a case over off-label marketing claims for two cancer treatments — Thalomid (thalidomide) and Revlimid (lenalidomide). Read More