With dosing complete in its phase II trial testing Ra Pharmaceuticals Inc.'s RA-101495 in generalized myasthenia gravis (MG) and date likely to roll out near the end of this year, the world already has begun weighing odds of the compound in a space where the likes of Alexion Pharmaceuticals Inc. and Argenx SE are formidable players. Read More
With the FDA closing out the month of November with three approvals in the last week – Vitrakvi (larotrectinib) from Bayer AG and Loxo Oncology Inc., Xospata (gilteritinib) from Astellas Pharma Inc. and Firdapse (amifampridine phosphate) from Catalyst Pharmaceuticals Inc. – the industry surpassed the high-water mark for the number of new molecular entities (NMEs) approved in one year in the U.S., previously set in 1996 when the agency approved 53 NMEs. Read More
