Take a look at what’s happening this week with pharma and biotech regulatory intelligence!
- President Obama has signed into law the 21st Century Cures Act, a $6.3 billion bill to fund and promote the accelerated development of new drug cures. Despite the fact that a previous version of the bill stalled in the Senate for over a year, the Cures Act signed by Obama has become a symbol of bipartisan effort. (Washington Post)
- FDA grants priority review to AstraZeneca’s durvalumab for urothelial carcinoma. Durvalumab was also awarded breakthrough therapy status earlier this year. The agency is expected to make a final decision on the urothelial carcinoma indication in the second quarter of 2017. (FirstWord)
- FDA grants Biohaven orphan drug designation for BHV-0223, a sublingually administered, orally dissolving tablet for the treatment of amyotrophic lateral sclerosis (ALS). There have been no other clinical improvements or advances in ALS therapeutics since 1995. (PR Newswire)
- U.K. fines Pfizer $108 million for a licensing deal that triggered a 2,600% price increase in an epilepsy drug. The company refutes the findings and plans to appeal. (FiercePharma)
- Foundation for the National Institutes of Health (FNIH) releases “Framework for Defining Evidentiary Criteria for Biomarker Qualification.” Developed in partnership with government and industry stakeholders, the framework suggests biomarker developers focus on five specific steps: describing a statement of need, defining a specific context of use, performing a benefit analysis, performing a risk analysis, and concisely describing available evidence. (FNIH)