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Lilly preps FDA run for ‘triple-G’ weight loss drug with Phase 3 data

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With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year.

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Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

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As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.​ ​Read More

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Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out

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The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

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5 companies advancing ATTR assets in the wake of Wainua’s fail

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The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.

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