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Biogen Decision Clarifies FDA Alzheimer’s Standard, Bristol Says

Biogen headquarters in Cambridge, Massachusetts.
Biogen headquarters in Cambridge, Massachusetts.Photographer: Adam Glanzman/Bloomberg

The approval of Biogen Inc.’s Aduhelm clarifies the U.S. Food and Drug Administration’s standard for drugs for neurodegenerative diseases, making it easier to design studies for new therapies, said Samit Hirawat, chief medical officer of Bristol Myers Squibb Co.

“It was hard to gauge before what endpoints to really shoot for and what was the threshold,” Hirawat said, speaking on the company’s second-quarter earnings call Wednesday. Now, “we know what the threshold is,” he said.