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The U.S. has secured a hefty supply of COVID-19 monoclonal antibodies, but challenges in administering the potentially game-changing treatments and skepticism around their efficacy have contributed to their minimal use. Now, a newly issued Emergency Use Authorization (EUA) for an antibody combo could inspire greater assurance in the drugs as potential treatments for preventing hospitalization. Read More
The company said it “remains committed to making its vaccine available” in India and plans to resubmit its approval request with additional information as it becomes available. Read More
The FDA has approved Bristol Myers Squibb’s CAR T cell therapy Breyanzi for treatment of adults with relapsed or refractory large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. Read More
Novavax released interim results last week from a phase 3 UK trial, demonstrating its vaccine showed 89.3 percent efficacy against the coronavirus and the UK variant. Read More
The authorization from the UK’s Medicines and Healthcare products Regulatory Agency followed a positive recommendation from the European Medicines Agency in November 2020. Read More
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has begun a rolling review of Regeneron’s REGN-COV2 antibody combination (casirivimab/imdevimab) for treating and preventing COVID-19. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
The FDA has delayed its review of Biogen and Eisai’s highly anticipated Alzheimer’s treatment candidate aducanumab, pushing back its action date to June 7 after deciding it needs more time to review additional analyses and clinical data from the drugmakers. Read More