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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The verdict is in: The FDA approved Biogen’s controversial Alzheimer’s drug, a decision that has rippled through the industry and spurred debate on the clinical evidence necessary for a coveted green light. It has seen members depart from the agency advisory panel that helped review the medicine, and potentially opened up a foothold for the drugmaker’s competitors in a multibillion-dollar market. But now Aduhelm—carrying the amyloid hypothesis and a $56,000 price tag—is here, and for years at least, while a new clinical trial is conducted to deliver the final word. | |
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Featured Story | By Noah Higgins-Dunn The verdict is in: The FDA has approved Biogen’s controversial Alzheimer’s treatment aducanumab. What's next? A ripple effect across Alzheimer's research, more controversy for the FDA and an all-out launch effort at Biogen, which really needs the sales boost. read more |
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Top Stories Of The Week By Nick Paul Taylor A member of the advisory committee that recommended rejecting Biogen’s aducanumab has quit over the FDA’s approval of the drug, Stat reports. Washington University neurologist Joel Perlmutter left “due to this ruling by the FDA without further discussion with our advisory committee.” read more By Noah Higgins-Dunn Biogen didn't just win the most closely watched FDA green light of the year. It snagged a "shockingly broad" label, set an aggressive $56,000 price and now stands poised for "one of the biggest drug launches in biopharma history," analysts say. The upshot? $10 billion in peak sales—or more. read more By Annalee Armstrong The FDA seems to have set a new regulatory standard with its approval of Biogen’s aducanumab, now known as Aduhelm, in Alzheimer’s disease under an accelerated review pathway. So now what? Pharmaceutical companies and biotechs are surely asking this question in the aftermath of the controversial approval. read more By Ben Adams The amyloid theory just won’t die. In fact, by approving Biogen's new Alzheimer's disease drug, the FDA has just resurrected it for a long and healthy future. This is great news for Biogen, but it will decimate Alzheimer’s research, faith in the agency and the healthcare budget for decades to come. read more By Fraiser Kansteiner With a semaglutide obesity green light in hand, Novo Nordisk is gearing up for one of its "fastest" launches ever, execs said on an investor call Monday. The drug will debut June 10 at a list price similar to Saxenda's, which retails for about $1,300 before insurance. read more By Conor Hale Dexcom accelerated the development of the newest version of its mainstay continuous glucose monitor, and delivered new clinical data showing that CGM systems can provide significant benefits to patients with Type 2 diabetes. read more By Conor Hale Now available in the U.S. with a prescription, the Galleri test is meant to screen people who may already have an elevated risk for cancer, such as adults over the age of 50. It's the latest in a potential wave of blood tests for cancer. read more By Fraiser Kansteiner After shining a spotlight on America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and a sweeping strategy to boost domestic drug production. The plan includes a new public-private manufacturing consortium, investments in advanced production technologies and more. read more By Beth Snyder Bulik Pharma companies are getting in the game—using gamification that is, to train sales reps, onboard new employees, reinforce information about new products and even have fun. That became even more important during the pandemic, says The Game Agency and some of its pharma clients. read more By Arlene Weintraub Alpine Immune Sciences turned heads when AbbVie formed a deal with the company for a lupus drug that inhibits the immune protein CD28. But the company is also pursuing a strategy for stimulating CD28 to improve the immune response to cancer—and it presented evidence at ASCO that its plan may be working. read more Resources Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. 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