| | | |   | It's Meghana again. Some big Aduhelm news, as well as a Pfizer acquisition in the RSV space. Happy Friday. | | | Medicare will not pay for Aduhelm, for the most part Medicare announced yesterday that it will officially restrict coverage for the costly, controversial Alzheimer’s drug Aduhem — paying only for patients participating in clinical trials. The decision marks the end of an intense pressure campaign from drugmakers and patient advocacy groups that wanted Medicare to pay for the Biogen drug.
The coverage decision is not specific to Aduhelm, and could apply to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval. In a major win for Lilly, however, Medicare said it will not require the exact same restrictions for drugs that aren’t approved based on surrogate endpoints. Read more. | Pfizer buys RSV therapeutics maker for $525 million Pfizer already has an RSV vaccine candidate in development, but the company is upping the ante in this space: It announced yesterday that it will acquire ReViral and its arsenal of RSV antivirals for $525 million. The company’s oral drug, sisunatovir, blocks respiratory syncytial virus from fusing to cells. A Phase 2 challenge study showed that the treatment could substantially reduce viral load in healthy adults. The drug’s also being tested in infants, who are particularly susceptible to RSV. Sisunatovir has been fast-tracked by the FDA. Meanwhile, Pfizer’s experimental RSV vaccine RSVpreF has won breakthrough designations for preventing RSV in both adults and infants. Pfizer expects that the ReViral assets could ultimately bring in more than $1.5 billion each year. | The power of perseverance in neuroscience For decades, conditions of the nervous system have been some of the most complex to understand and treat. Through scientific rigor and unwavering perseverance, one biotech company is asking the tough questions of themselves, the industry and society to push the boundaries of scientific understanding and discovery. Learn more about Genentech and Roche’s commitment to scientific advancement in neuroscience. | What’s on tap for Roche? …And its closely followed cancer immunotherapy? Are we all headed for another shot with a Covid-19 vaccine? And what explains the recent success of Vertex Pharmaceuticals’ R&D pipeline? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Reporter Andrew Joseph joins us to discuss the FDA and its meeting with outside advisors that considered questions about Covid-19 boosters and the potential for updated vaccines that better match the circulating strains of SARS-CoV2. We’ll also dive into a look at Vertex and hear from its top executives about two experimental, but potentially groundbreaking, treatments for pain and type 1 diabetes. And as we often do, we’ll kick off the podcast with a Chatty Cathy round of hot takes on this week’s news. Listen here. | Aduhelm triggers board exodus for aging advocacy Half the scientific advisory board of the Alliance for Aging Research has resigned, after learning that the advocacy group lobbied against the aforementioned Medicare proposal to restrict coverage of Aduhelm. The organization held a rally last month in front of CMS offices to protest a preliminary decision over Medicare coverage — which led to nine of the 17 board members to leave. The Alliance for Aging Research isn’t the only advocacy group to join this particular cause. It and others have argued the CMS proposal is misguided because it denies coverage to desperate patients and their families. Read more. | More reads - C2i Genomics snags European approval for blood test to detect residual cancer. (FierceBiotech)
- Norovirus vaccine developer HilleVax files for a $100 million IPO. (Renaissance Capital)
| Thanks for reading! Until next week,  | | | |
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