BioCentury
ARTICLE | Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

June 2, 2020 2:06 AM UTC

CHMP backs Ebola vaccine, targeted cancer therapies
EMA’s CHMP recommended approval of a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Friday. The agency also backed two targeted cancer therapies: PI3Kα inhibitor Piqray alpelisib from Novartis AG (NYSE:NVS; SIX:NOVN) to treat hormone receptor-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer following disease progression; and Rozlytrek entrectinib from Roche (SIX:ROG; OTCQX:RHHBY) to treat NTRK fusion-positive solid tumors and ROS1-positive, advanced non-small cell lung cancer (NSCLC). Rozlytrek inhibits ROS1, TrkA, TrkB, TrkC and ALK.

FDA approves fibroid-associated menstruation therapy
AbbVie Inc. (NYSE:ABBV) and Neurocrine Biosciences Inc. (NASDAQ:NBIX) said FDA approved Oriahnn elagolix, estradiol and norethindrone acetate as the first oral treatment option for managing heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. AbbVie expects the drug to be available in the U.S. by the end of June...