| | | |   | | | 5 questions about the future of Alzheimer’s drugs Last week, a House investigation released a cache of documents relating to the controversial approval and ruinous rollout of Biogen’s problematic Alzheimer’s drug, Aduhelm. (Read about that in depth here and here.) The inner dynamics of the Aduhelm debacle were made public just days before the FDA is likely to approve another Alzheimer’s drug, lecanemab. So we’ve got some questions. Top of mind: Did anyone at the FDA get in trouble? Who in the FDA suggested Aduhelm’s broad label? And does the congressional report mean for lecanemab? STAT’s Adam Feuerstein and Damian Garde go over all that, and then some. Read more. | HHS, FDA, CMS and NIH have a whole lot to do The country’s health agencies have a lot on their respective agendas this year. For one, there’s still no leader at the NIH. Top officials have promised regulatory reforms in the wake of the uneven Covid-19 response and last year’s baby formula shortages. The Biden administration is now working to fix gaps in mental health care, addiction treatment, and health coverage — even though millions of people will probably be kicked off of Medicaid. And given the Republicans’ efforts to block further coronavirus funding, and it looks as though new iterations of the Covid-19 vaccines may be harder to produce and supply: “Put all that all in the context of no money and little appetite [among the public] to pay attention,” one agency official told STAT. “But really, the virus doesn’t care.” Read more. | Is boldness the solution to R&D challenges with bispecific antibodies? Despite their inherent challenges, bispecific antibodies (bsAbs) hold promise in improving the future of cancer care. T cell manipulation via bsAbs creates room for flexibility in immunotherapy research, with the ability to be studied individually as monotherapy or in combination with other oncologic treatments. Regeneron has spent over a decade researching bispecific antibodies, following the science to gain an innate understanding of the bsAbs landscape to utilize them in emerging research in oncology. Learn more. | What’s up ahead in this next biotech quarter? Another biotech scorecard, this time for Q1 of 2023! Lots of stock-moving biotech events on the horizon, with one of the biggest at the end of this week: As we noted, the FDA will deem whether Eisai’s Alzheimer’s drug, lecanemab, is worthy of approval on Friday. The agency will also evaluate approvals from seven more companies between now and March 20. We’re also expecting an eventful year in the gene therapy space — with submissions for sickle cell disease coming from Bluebird Bio and Vertex Pharmaceuticals (and partner Vertex Pharmaceuticals). Notably, Moderna will release clinical updates on its experimental flu and RSV vaccines. And there’s so much more! Read more. | Eric Lander’s new nonprofit, Science for America Two years ago, President Biden named renowned Broad Institute genomics researcher Eric Lander as the new White House science adviser — the first time this job’s been elevated to a cabinet position. The task was simple: “reinvigorating” American science. But he resigned this past February, following accusations of workplace bullying. STAT reported that he’ll be leading up a new nonprofit called Science for America — meant to serve as a “solutions incubator” for pressing issues like climate change, the energy crisis, as well as health issues like cancer and pandemic preparedness. It’ll also foster innovation in STEM education equity, synthetic biology, artificial intelligence, semiconductors, and quantum computing. The nonprofit will be funded by Bloomberg Philanthropies, Emerson Collective, the Ford Foundation, Gates Ventures, and Schmidt Futures — which have committed $30 million over two years. Read more. | More reads - FDA criticized for working too closely with biotech company to approve Alzheimer’s drug, PBS Newshour
- Ex-Seagen CEO Clay Siegall won’t face charges following arrest, domestic violence allegations, GeekWire
- The Aduhelm Operetta: ‘I’ve got a little list,’ STAT
| Thanks for reading! Until tomorrow,  | | | |
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