| | | |   | Back after a virtual whirlwind from J.P. Morgan. We talk Califf, we talk Biogen, we talk chimeric antigen receptors in today's Readout. Meghana here! (After observing Martin Luther King Jr. Day on Monday, The Readout will be back in your inboxes on Tuesday, Jan. 18.) | | | Biogen considering acquisitions Biogen is taking a much-needed step away from its embattled Alzheimer’s drug, Aduhelm — building a hefty list of potential acquisitions, STAT's Damian Garde and Adam Feuerstein report. The company, whose stock has been down nearly 50% since Aduhelm was approved, is now working with Goldman Sachs to target smaller biotechs with a neuroscience bent. This list includes Biohaven Pharmaceuticals, which makes migraine therapies; Aurinia Pharmaceuticals, which recently won approval for its lupus drug; and Amylyx Pharmaceuticals, which is seeking approval for its ALS treatment. Not everyone believes the company will have an about-face and suddenly become acquisitive. “I worry that despite their assertions otherwise, they have so much conflict at a board level, and at a management level, that there’s too much gridlock to do anything other than beat the drum of ‘must sell aducanumab, must sell aducanumab,’” one analyst told STAT, using the generic name for Aduhelm. Read more. | One step closer to re-upping Robert Califf A Senate committee was split Thursday, but still advanced Robert Califf’s nomination to be FDA chief once more. Members voted 13 to 8, with some Democrats — including Bernie Sanders — worried that he wasn’t sufficiently committed to combatting the opioid epidemic, the New York Times writes. Meanwhile, North Carolina’s Richard Burr, the ranking Republican member, called Califf’s experience “unparalleled” for one of the “most significant public health positions in the federal government.” If he’s confirmed, the cardiologist will have quite the uphill battle: The FDA is under immense pressure and scrutiny due to the pandemic. | What should biotech companies consider when developing an asset? Emerging biotech companies continue to be a productive and innovative force across the biopharma development market. However, these companies are typically very lean on internal resources and sometimes even “virtual” by design and may require guidance to develop and take an asset to market. In a new whitepaper, learn how emerging biotech can navigate these complexities, and achieve optimal success in their partnerships and all aspects of product development. | The next wave of CAR-T therapies A new generation of CAR-T cell therapies is well on its way — with a number of new incarnations in late stage development. Take the controllable CAR: Some scientists are working on developing immune cells that they can manually activate or deactivate, so they don’t go haywire (as they are currently wont to do) when reintroduced into a patient’s body. Then there are the logic-gated CARs, which work like biomolecular computers: They’re able to make simple, logical decisions to target cancer cells, STAT’s Angus Chen writes. Another intriguing form is the armored CAR, which can protect itself against hostile conditions that can be found in a solid tumor environment. Other scientists are thinking outside the box — developing entirely novel sorts of cells. Or, perhaps, even a completely artificial cell: “Instead of taking a cell from a patient, but rather build a completely defined, minimal cell that can do what we want and nothing else. It cannot evolve. Cannot mutate. Then, self-destruct when you don’t want it there,” said one scientist, imagining a futuristic — but yet-to-be-designed — cell. Read more. | Was J.P. Morgan a drag? Is it time to give up on Aduhelm? And how many guitars is too many? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT health tech correspondent Katie Palmer joins us to recap the J.P. Morgan Healthcare Conference. Then, we discuss the latest twist in Biogen’s quest to expand the use of Aduhelm and what it means for the treatment of Alzheimer’s disease. Finally, Arrakis Therapeutics CEO Michael Gilman calls in to explain how targeting RNA can treat disease and why the characters in “Dune” don’t just shoot each other with laser guns. Listen here. | More reads - FDA warns Chinese manufacturer for lack of vision when making sterile eye drops. STAT
- Strong new evidence suggests a virus triggers multiple sclerosis. STAT
- With its Aduhelm proposal, Medicare is stepping into a heated debate about how best to improve equity in Alzheimer’s treatment. STAT
| Thanks for reading! Until next week,  | | | |
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