| | | |   | Good morning, everyone. Damian here, sharing with you the news of the STATUS List, our inaugural accounting of the most influential leaders in health, medicine, and science. It arrives Feb. 22, and you can learn more here. | | | The FDA isn’t exactly sold on Chinese-developed cancer drugs Billions of pharma dollars are riding on the idea that the FDA will approve new cancer medicines based on data from Chinese clinical trials. But judging by the words of the agency’s top oncologist, the drug industry might have to rethink its plan.
As STAT’s Adam Feuerstein reports, the FDA’s Richard Pazdur described imported cancer drug data from China as a “bridge over troubled waters.” He singled out sintilimab, a checkpoint inhibitor developed by the China-based drugmaker Innovent and licensed to Lilly, writing in Lancet Oncology that the treatment’s pivotal trial “raises questions regarding the data from a single foreign country to support U.S. approval and its generalisability to the American population.”
That’s a bad sign for sintilimab, which is up for FDA approval and will go before a panel of external advisers at a meeting Thursday. And it’s ominous for companies including EQRx and Coherus BioSciences, which have licensed Chinese-developed cancer medicines in hopes of winning FDA approval and competing with existing drugs on price.
Read more. | The plot to rescue Robert Califf With Robert Califf’s path to FDA commissioner looking increasingly fraught, some of the nation’s most influential doctors and public health groups are orchestrating a last-ditch effort to drum up Senate support for President Biden’s nominee.
As STAT’s Nicholas Florko and Rachel Cohrs report, advocacy groups, medical societies, and even celebrity doctors are working the phones to make the case for Califf. The lack of a permanent FDA commissioner during a pandemic is “tragic,” one prominent physician said. And the push to get Califf confirmed is “the ‘break glass in case of emergency’ moment,” according to a patient advocate.
Califf’s confirmation once looked like a guarantee, but in recent weeks, more than a dozen Senate Democrats have expressed uncertainty or objections to his candidacy.
Read more. | Advanced clinical solutions powered by healthcare intelligence — delivered seamlessly For one more week only, access our best rates! On March 31, we're gathering knowledgeable ICON is the world’s largest and most comprehensive clinical research organization, powered by Healthcare Intelligence. Leveraging their human expertise, robust clinical capabilities, and insightful data resources, ICON is expanding the possibilities of clinical research without sacrificing the vital, day-to-day functions of today’s CROs. Learn more. | They won’t even let Shkreli talk about biotech A federal judge upheld Martin Shkreli’s lifetime ban from the pharmaceutical industry, issuing an injunction that would even limit the incarcerated entrepreneur’s public statements about biotech companies.
In an opinion issued Friday, U.S. District Judge Denise Cote overruled Shkreli’s objections to the scope of the punishment, writing that he is “hereby banned and enjoined for life from directly or indirectly participating in any manner of the pharmaceutical industry.” That means he can’t run a drug company, work at one, or directly hold shares in one. He also cannot do anything “to directly or indirectly influence or control the management or business” of a drug company, Cote wrote, and that extends to anything he says in public “if Shkreli intended the statement to have that effect or if a reasonable person would conclude that the statement has that effect.”
That definition would seem to capture pretty much anything one could ever say about a drug company. “This company is bad” could be construed as an attempt to exert indirect influence on a firm to change its business, just as “This company is good” could read as words intended to keep a firm on the same track. When Shkreli gets out of federal prison in November, the only safe public statement on biotech might be “This company exists.” | A biotech IPO that didn’t break There’s a growing consensus that there are simply too many public biotech companies, and more than 80% of 2021’s class of IPOs are trading below the price at which they went public. That makes it notable that Arcellx, an early-stage oncology biotech, not only executed an IPO but managed to trade up in the hours after.
Arcellx raised about $124 million on Friday, pricing its shares at $15 each. By the end of the day, it was up to $16.80, making for a 12% instant return.
This would hardly be worth a mention back in 2020, when the average biotech IPO rose more than 30% on the day of its debut. But in 2022, when it’s commonplace for companies to immediately break issue or delay their IPOs altogether, Arcellx represents a rare positive datapoint in a dismal biotech market. | More reads - The quest for the small molecule holy grail with Merck’s head of R&D. STAT+
- ‘I am deeply sorry for my conduct’: Biden's top science adviser apologizes to staff. Politico
- After some lengthy delays, Sanofi gets the FDA's OK for a rare disease drug. Endpoints
- Manufacturing at the edge: smaller, localized, and agile factories will be key to biopharma drug production. STAT+
| Thanks for reading! Until tomorrow,  | | | |
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