Latest From Andy Smith
Biogen’s recent contentious approval put the cat amongst the pigeons in the debate on surrogate markers as a basis for accelerated approval. The history of such approvals goes back to the last century.
Factors in addition to the rejuvenation of pharmaceutical revenues and biotechnology product failures are likely to pull in opposite directions at the sector’s recovery from the pandemic.
Revenues are still elusive for a surprising number of the novel drugs approved by the FDA five years ago. Emergent safety issues and confirmatory clinical trial failures were less common than lack of competitiveness as the main reason for revenue weakness.
Veklury rescued Gilead’s weak underlying first-quarter performance. But the pandemic and its associated behavioral effects, as well as patent expiries, will continue to drag.
Recently launched branded drugs prescribed by specialist physicians and marketed by smaller commercial-stage biotech companies remain in the eye of the pandemic storm.
Influenza and pneumococcal vaccine sales were initially strong at the start of the pandemic. Recent weak revenues for travel, childhood and premium vaccines could raise population immunity concerns, however.