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In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public’s access to medicines but upend the future of drug regulation, forcing the 114-year-old agency to do the equivalent of redesigning a fighter plane in mid-flight. With its conditional clearance of Biogen’s Aduhelm, the FDA is creating a framework that could require less certain evidence of safety and efficacy for medicines beyond Alzheimer’s treatments. In doing so, it is choosing to alter many of its well-established processes and standards, seemingly on the fly. (Herper, 6/7)

Following the FDA's approval of Biogen's Alzheimer's treatment Aduhelm, experts fear the approval — based on weak scientific data — is a sign the agency is putting speed over rigor. "A general signal being sent to the rest of the drug industry is: If you can get uncertain, maybe suggestive data and a post-hoc analysis — get that threshold to us — we may approve your drug," said Peter Bach, a drug researcher at Memorial Sloan Kettering Cancer Center. (Herman, 6/8)

Dementia expert Dr. Jason Karlawish told CNBC he’s skeptical of the Food and Drug Administration’s approval of Biogen’s Alzheimer’s disease drug, Aduhelm, saying “the evidence to approve the drug wasn’t sufficient.” “Another study is needed to establish whether this drug, in fact, is effective. Unfortunately, the FDA approved the drug for marketing, although they also do want another study,” the co-director of the Penn Memory Center at the University of Pennsylvania said on Monday following the agency’s formal OK. (DeCiccio, 6/7)

As Biogen stock soared 38% Monday on the surprise Food and Drug Administration approval of its hotly debated treatment for Alzheimer’s disease, investors bid up the shares of would-be competitors large and small. Eli Lilly was the biggest beneficiary, rising nearly 12% and adding more than $20 billion in market capitalization. Like Biogen’s drug, called Aduhelm, Lilly’s most advanced Alzheimer’s treatment targets toxic brain plaques called beta amyloid. AC Immune, a Swiss biotech company with a once-failed amyloid treatment of its own, rose about 26%. Prothena, which has an amyloid-targeting drug in early-stage development, went up 27%. (Garde, 6/7)

Multiple sclerosis drug Tecfidera has propped up Biogen for the past eight years, representing more than a third of the company's sales. But that revenue wave is coming to an end after generic versions of the pill entered the U.S. market last year. Biogen is banking on federal approval of its Alzheimer's drug, aducanumab, to boost its financial future and offset the decline of Tecfidera. (Herman, 6/7)