Aug. 27 - Verzenio’s survival data, Sanofi’s new CMO and accelerated approval risks

Amylyx drug comes up short; Sanofi names new CMO; FDA’s new accelerated pathway may open pharma up to risks, as well as benefits; Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T; RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial

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Aug. 27, 2025 | Today’s news and insights for biopharma leaders

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Lilly says breast cancer drug extended survival in study

Treatment with Verzenio helped people with a common type of early breast cancer liver longer than those given standard hormone therapy.

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Amylyx drug comes up short; Sanofi names new CMO

AMX0035 missed the goals of a study in progressive supranuclear palsy. Elsewhere, Novartis and BioArctic struck a deal, and Genentech started building its first East Coast factory.

FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

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Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T

The St. Louis-based biotech hopes to submit an application for its leukemia and lymphoma therapy in 2027, if all goes well in an ongoing trial.

UPDATED

RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial

Cemdisiran helped control symptoms of generalized myasthenia gravis, but combination treatment with a Regeneron antibody didn't appear as effective.

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