| Sponsored by  | | |  | Hello from Day 2 of the 2023 J.P. Morgan Healthcare Conference. Here's the latest from rainy San Francisco, courtesy of our reporters on the ground — Adam Feuerstein, Matthew Herper, Allison DeAngelis, Jonathan Wosen, Jason Mast, Bob Herman, and Mohana Ravindranath. | | | 
Taken just before every iPhone user at J.P. Morgan got a flash flood warning (Adam Feuerstein) Califf addresses the Aduhelm files The FDA has said little thus far about the congressional investigation into Aduhelm's approval. But last night, FDA Commissioner Robert Califf joined STAT’s Matthew Herper onstage for a live event where in which Califf addressed the recently released report at length.
“There were no surprises in the report,” Califf said. “The language is inflammatory, I think, on purpose, because that’s what oversight committees do.”
Califf said the FDA was focusing on making sure it does a better job keeping track of every meeting with a company, which was one area of controversy. He also noted that, thanks to new powers the FDA is being granted by Congress, in the future drugs will only be granted accelerated approval if a confirmatory trial is underway. In addition, Califf said that the FDA would be looking to make better use of its committees of outside advisors — including, potentially, with regard to Eisai and Biogen’s Alzheimer’s drug, Leqembi, which was recently granted accelerated approval but will soon be up for full approval. “Stay tuned,” Califf told the audience, “there’s more to this story to come.”
Read more. | Cash-strapped startups fuel royalty deal flow One company’s woes are another’s opportunity. At least that’s the case for Xoma, a life sciences company that pivoted from drug development in 2017 to offering upfront cash in exchange for companies’ future royalty payments. With the private and public markets still in a shaky state, many of the startups bustling around San Francisco’s Union Square this week are looking into options like debt and royalty deal sales, and Xoma has had a notable influx of meeting requests this year, executives told STAT. The Xoma team has more than 60 meetings scheduled during this year’s conference alone. For comparison, they held 180 business development meetings in all of 2022.
“The last few years, a lot of the dynamics have changed,” Xoma’s Chief Financial Officer Tom Burns said. “Debt has become a lot more expensive. Equity has become a lot more expensive. It places us in a good position.”
Xoma isn’t the only one: On Monday, Ionis Pharmaceuticals said it is selling a portion of its royalties in Spinraza and pelacarsen to Royalty Pharma, in exchange for $500 million upfront and up to $625 million in milestones. | Sponsored insight by Amgen 5 ways biotech can help support patients and their communities As a company, Amgen’s mission is to serve patients, and while innovating new medicines may be at the core of what they do every day, staff are always excited for new ways to serve not only patients, but also the communities where they live and work. Learn more about how the people of Amgen came together in 2022 to help patients, families and communities live happier, healthier lives. | Dr. Oz meets Moderna The Readout crew loves a good biotech-meets-celebrity mashup story. Last December, we told you about Taylor Swift and her “appearance” at a New Orleans party hosted by a Wall Street investment bank during the annual meeting of the American Society of Hematology.
We have another one. Mehmet Oz, the celebrity physician, former friend of Oprah, promoter of hydroxychloroquine, and defeated Pennsylvania (or was it New Jersey?) candidate for the U.S. Senate, was spotted Monday inside the Westin St. Francis hotel listening to Moderna CEO Stéphane Bancel give his J.P. Morgan presentation. He was also seen chatting up folks in the hotel’s cafe.
It’s not clear why, exactly, Oz is wandering around the Westin this week. We all love the way Bancel pronounces "modality," but a well-placed source tells us Oz has no involvement with Moderna. But JPM week has been on his wish list: He told Insider reporter Andrew Dunn that he was too busy filming his talk show in previous years to attend. | Device safety: piling 'errors on errors' Imagine this: a new medical device is approved, based on being similar to an earlier medical device. But then, it turns out that earlier device — an artificial shoulder, perhaps, or an infusion pump — was itself recalled not for some technicality but because, in the FDA’s words, it’s possible it will cause “serious health consequences or death.”
A group of researchers has confirmed the obvious: That new device is six times more likely than comparable devices to be recalled for causing serious harm — creating what they say is a severe regulatory loophole.
“What happens is you’re piling errors upon errors,” said cardiologist Steven Nissen, who was not involved in the study.
Read more. | More reads - Is the golden age of biotech stocks over? STAT
- Illumina, the DNA sequencing giant, gives Wall Street some bad news, STAT
- Sen. Sanders asks Moderna not to hike Covid vaccine price, Reuters
- BioNTech buys U.K. AI start-up InstaDeep in £562 million deal, Financial Times
- New Biogen CEO: New drug launches, more cost cuts, but no ‘radical left turns’ needed, STAT
That's all for today. See you tomorrow! | | | |
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