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FDA accelerated approval path needs improvement, says ICER
The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.
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Lilly says Foundayo safety confirmed in ACHIEVE-4 trial
Eli Lilly's ACHIEVE-4 trial results for oral GLP-1 Foundayo set up a filing in diabetes, and provide safety data sought by the FDA.
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Pushing through barriers to commercial launch success, with ...
In this sponsored pharmaphorum podcast, Amanjeet Singh Saluja, a Principal at Axtria, discusses the current state of affairs in launch success.
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Daiichi exits OTC, with $1.55bn unit sale to Suntory
Daiichi Sankyo has agreed to sell its consumer health unit to food and beverage giant Suntory, following a well-trodden path for big pharma companies.
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FDA seeks safety data for Lilly's oral GLP-1 Foundayo
The FDA has laid out post-marketing safety testing requirements for Lilly's weight-loss pill Foundayo, including clinical trials.
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