Half of Merck’s sales are in jeopardy. Can Keytruda’s sequel save the day?

Wall Street analysts expect the subcutaneous version of Keytruda, which just launched last week, to help soften the blow when the original loses patent protection later this decade.

Lexeo says FDA open to speedier approval of rare disease gene therapy

The agency will consider a submission that includes pooled data from ongoing studies, a decision analysts viewed as a notable, additional sign of regulatory flexibility for gene therapies.

Unlocking the potential of AI in pharma

Amgen claims ‘landmark’ study result that could widen heart drug’s use

In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population. 

AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer

The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.

Gilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule

A settlement could extend the exclusivity of the world’s best-selling HIV medicine to 2036. Elsewhere, an AstraZeneca drug acquisition paid more dividends and a Vertex veteran became Stoke’s full-time CEO.

FDA clears generic abortion pill; CMS punts ‘combo drug’ guidance

The decision to clear another mifepristone generic sparked political backlash. Elsewhere, investors will pump up to $175 million into Ovid after the company reported early, but encouraging, data for a potential epilepsy drug.