Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.

In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.