Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium
FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab, which is eligible for a $30 million milestone on the first commercial sale. FDA reviewed the sBLA for the therapy, which uses Enhanze delivery technology from Halozyme Therapeutics Inc. (NASDAQ:HALO), under its Real-Time Oncology Review pilot program and Project Orbis.
Thermo Fisher grows EU manufacturing presence with €725M deal
Thermo Fisher Scientific Inc. (NYSE:TMO) acquired Henogen S.A., Novasep’s viral vector manufacturing business of Groupe Novasep SAS in Belgium, for about €725 million ($884 million) in cash. The deal, which gives Thermo Fisher locations in Seneffe and Gosselies, is part of the company’s push to expand its global capabilities for cell and gene vaccines and therapies. ...