Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
Should the U.S. government be in the business of manufacturing COVID-19 vaccines? Several prominent Democratic senators and representatives would say yes.
Usama Malik, Immunomedics Inc.’s former chief financial officer, and his former partner, Lauren Wood, face SEC charges related to insider trading in Immunomedics’ stock.
What one analyst called “the single most important” nucleoside reverse transcriptase inhibitor in development – Merck & Co. Inc.’s islatravir – has met rocky terrain, with the firm and its partner, Gilead Sciences Inc., pausing combo trials.
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
Enacting provisions to control U.S. prescription drug prices remains a top priority with many members of Congress as they push through the Biden administration’s budget agenda – despite warnings that government price controls on drugs would come at the cost of innovation.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
As a first step in developing a portfolio of COVID-19 therapies, the European Commission identified five promising candidates June 29, including four monoclonal antibodies under rolling review at the EMA and an immunosuppressant that could have its marketing authorization extended to include the treatment of COVID-19 infections.
Wall Street must wait a while longer to find out if Gilead Sciences Inc. will exercise its $275 million option for Arcus Biosciences Inc.’s TIGIT binder, domvanalimab. Meanwhile, investors took heart from an optimistic – albeit vague – interim report on the phase II ARC-7 trial.
Shares of Vir Biotechnology Inc. (NASDAQ:VIR) and Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) each rose modestly on June 21 as both delivered positive updates on their COVID-19 programs. Vir and its partner, Glaxosmithkline plc, shared final clinical data confirming the efficacy of their monoclonal antibody therapy, sotrovimab, following an FDA emergency use authorization for the therapy last month. Cumberland announced five case studies in which its antibiotic, Vibativ (telavancin), successfully treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.
