Look back at pharma news in the week to October 23, 2020

Last week saw the US Food and Drug Administration’s vaccines advisory committee deliberate on the approval process for vaccines against COVID-19. Among research news, US biotech Aptinyx scored a hit with investors when it presented Phase II results with its post-traumatic stress syndrome candidate NYX-783. Along with its third-quarter financials, Biogen updated on progress with its Alzheimer’s candidate aducanumab. Gilead Sciences gained full approval from the US FDA for its coronavirus treatment Veklury.

Did VRBPAC push back on EUA guidance? Could expanded access be used instead?

Commenting on the US FDA’s virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), analysts at SVB Leering Research said, as expected, there was no pivotal trial data presented, and as far as they could tell no pivotal trial efficacy data or emergency use authorization (EUA) applications have been presented to the agency. Most of the meeting was background information about COVID disease and the activities of federal agencies and institutes such as the NIH, CDC and FDA with respect to COVID vaccine development, and explanation of the FDA’s two COVID vaccine guidance documents, but the meat of the discussion came in the afternoon.