1. President Obama signed the 21st Century Cures Act into law. The bill will force FDA to draft guidance within two years on the use of real-world evidence in supplementary indications of already approved drugs and clarify the scope of information drugmakers can share with payers.
2. The FDA has only approved 19 new drugs so far in 2016, the lowest amount since 2007. At the same time, an analysis by Deloitte Life Sciences Solutions found that peak sales per drug for the top 12 global pharmaceutical companies have declined by 11.4% year-over-year since 2010. (Endpoints)
3. Sanofi is reportedly close to a deal with Actelion to acquire the company. Actelion holds a portfolio of drugs that treat pulmonary arterial hypertension. (Reuters)
4. The FDA cleared the wireless integration of Johnson’s and Johnson’s OneTouch Verio Flex blood-glucose monitoring system with WellDoc’s diabetes platform. The partnership will allow patients with diabetes to get real-time feedback and virtual coaching based on a specific treatment plan.
5. Bristol-Myers Squibb is restructuring its U.S. R&D operations. The drugmaker will focus its operations in Lawrenceville, New Jersey, San Francisco, and Cambridge, Massachusetts. It plans to shutter a facility in Hopewell, New Jersey, and will not renew a lease in Seattle. (PMLiVE)