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 U.K. is planning to move Roche’s Kadcyla (trastuzumab emtansine) into the NHS’s routine funding programs later this summer, following guidance from the National Institute for Health and Care Excellence and an agreement from Roche to lower the cost of the breast cancer treatment. Read More
The PTO’s Patent Trial and Appeal Board said it will review patents covering the blockbuster erectile dysfunction drug Cialis and a widely used pneumonia vaccine, Prevnar 13, granting petitions from Mylan and Merck Sharp & Dohme Corp. Read More
An appeals court reinstated a wrongful-death lawsuit against Teva Pharmaceuticals, saying the lower court improperly ignored witnesses’ expertise and sent it back to a California federal court for a new trial. Read More
The PTO invalidated two more AbbVie patents on dosing regimens for Humira after continuing challenges from Coherus, which plans to submit its biosimilar version of the blockbuster drug for FDA approval later this year. Read More
Patients are 266 percent more likely to not pick up brand-name medications after requesting them at a pharmacy, compared to generic prescriptions, according to the Association for Accessible Medicine’s annual report. Read More