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.
The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
Novartis AG’s CAR T therapy, Kymriah (tisagenlecleucel), is heading for a third indication after the Basel, Switzerland-based pharma announced supportive results from a pivotal phase II trial, lining it up to compete with Gilead Sciences Inc.’s rival, Yescarta.
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players.
The rocky first quarter for public biopharmaceutical companies continued into April as the BioWorld Biopharmaceutical index remained flat for the period in contrast to the general market, with the Dow Jones Industrial Average growing by more than 2%. Weighing on the sector has been softer than expected earnings in the period among the top tier companies.
