Here’s a look at what’s going on this week with pharma and biotech regulatory intelligence!
- CDER’s accomplishments for 2016 and priorities for 2017. CDER Director Janet Woodcock’s priorities for 2017 include: developing a plan to automate processes for new drug reviews, implementing provisions of the 21st Century Cures Act, and supporting reauthorization of the user fee acts. (FDA)
- New postmarketing safety requirements for combination products. On December 19, FDA finalized new postmarket safety reporting requirements for combination drug/device, biologic/device, biologic/drug, or drug/biologic/device products. (FDA)
- FDA grants accelerated approval to Clovis Oncology’s Rubraca (rucabarib) for BRCA+ ovarian cancer. Rubraca was approved for the treatment of women with advanced ovarian cancer who have received two or more prior chemotherapies and whose tumors have a BRCA gene mutation, as identified by the CDxBRCA companion diagnostic test. (FirstWord)
- FDA approves removal of boxed warning for neuropsychiatric events for Pfizer’s Chantix (varenicline). Chantix is approved to help adults quit smoking. Removal of the boxed warning was based on the results of a randomized clinical trial designed to determine whether smokers with a history of psychiatric disorders are at a greater risk than other smokers for developing clinically significant adverse neuropsychiatric events. (Pfizer)
- European Medicines Agency (EMA) to launch a tailored scientific advice pilot to support the development of biosimilars. The pilot will advise developers on the studies they should conduct, based on a review of their available quality, analytical, and functional data. (RAPS)