Regeneron Pharmaceuticals, Inc.
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Latest From Regeneron Pharmaceuticals, Inc.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
The company insists it will reconsider the price of Aduhelm if the market turns out to be larger than Biogen anticipates, but big price reductions for branded drugs are rare.
Now that the actinic keratosis treatment Klisyri has got the green light in Europe, the Spanish firm's attention will be on atopic dermatitis and forthcoming Phase III data on lebrikizumab, a potential rival to Dupixent.
Japan has granted an emergency approval to Chugai/Roche/Regeneron's antibody cocktail after a rapid review, while India has emerged as one of the top purchasers globally of COVID-19 vaccines as it looks to protect more of its population.
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