Top Regulatory News Stories – Week Ending October 19, 2018

The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.  https://www.biospace.com/article/fda-approves-pfizer-s-talzenna-for-breast-cancer/ Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. https://www.biospace.com/article/amidst-strong-quarterly-growth-novartis-receives-fda-complete-response-letter-for-canakinumab/ Ocular[…]