CBER director suggests more flexibility on confirmatory study timing is warranted for accelerated approvals in rare diseases and even in some more common scenarios such as infectious disease outbreaks, although a ‘relatively stronger approach’ will apply to most large indications.

The pandemic created a tough environment for sales of both newly launched products and growing products, especially for small-to-medium enterprises. Scrip reviewed the second quarter earnings calls for several SMEs: some are continuing to feel pressure, and some are starting to recover. [See Part 1 for companies reporting a turnaround.]

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

GlaxoSmithKline's market value has slipped in the past three years and the number of failures in the clinic have grown. The major's leadership will be casting nervous glances towards a major shareholder that has a reputation for aggressive restructuring calls.