The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position.
Alexion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria.
Alexion Pharmaceuticals Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for approval of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Alexion Pharmaceuticals closed out the company’s first-quarter 2018 plans to seek regulatory approval for its paroxysmal nocturnal hemoglobinuria (PNH) treatment ALXN1210, which is considered the successor to the blockbuster blood-disorder drug Soliris.
Alexion Pharmaceuticals Inc.’s experimental drug to treat a rare blood disorder showed in an eagerly awaited study that ALXN1210 was not inferior to its flagship drug Soliris, paving the way for the company to establish a dominant position in the market as competition looms.
FDA plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of drugs for rare diseases and speed reviews of future applications.
A little more than two weeks after being placed on administrative leave, Gur Roshwalb – chief executive officer of Akari Therapeutics – resigned his position.