| |   | Good morning, all. Damian here with a reminder that you can join STAT on Wednesday for a virtual discussion on how the latest discoveries in cancer biomarkers are reshaping the standard of care. Our own Matthew Herper will host a panel of oncologists from around the country. You can sign up here. | | | Rough quarter, guys Biotech stocks are down about 30% over the past three months, as the mid-pandemic boom has morphed into widespread anxiety that the drug industry went over its skis some time in 2021. Conveniently, a bunch of pharmaceutical executives will have no choice but to talk about that in public this week.
A packed week of fourth-quarter earnings presentations begins today at 4:30 ET, when Gilead Sciences will get a chance to explain that, despite yet another setback, its ambitions in oncology are worth taking seriously.
But the bigger news is likely to come Thursday morning, when Biogen will host its first conference call since signing a $2.3 billion deal to sell its biosimilars business. The company has promised to spell out the details of its cost-cutting plan, and you can expect analysts to wring every parsable clue out of management’s response to questions about what Biogen might buy. | With pricing reforms stalled, the NIH could break a pharma barrier Time and again, congressional efforts to address the price of prescription drugs have run into political gridlock. But thanks to a little-used provision of federal law, the NIH could sidestep a costly drug’s patents and set a major precedent in the process.
As STAT’s Ed Silverman reports, the drug is Xtandi, a prostate cancer medicine sold by Pfizer and Astellas that traces its scientific origins to federally funded research at the University of California, Los Angeles.
Advocacy groups have called on the NIH to invoke what are called march-in rights, allowing it to license the Xtandi patents to generic manufacturers and thus bring down the roughly $189,900 annual cost of the drug. Next month, the agency will decide whether to hold a hearing on the idea, setting up what would be a seismic shift in the world of pharmaceutical intellectual property.
Read more. | The Exhaustion Epidemic: Examining the Covid-19 Burnout Crisis in Health Care Join STAT on Feb. 7 to discuss the solutions needed to support and retain health care workers experiencing burnout at unprecedented levels. Register here. | After six months and three delays, Novavax’s Covid vaccine is ready for the FDA Novavax submitted its Covid-19 vaccine for FDA authorization yesterday, following a protracted delay that could affect demand for the product.
As STAT’s Helen Branswell reports, Novavax’s filing came on the same day Moderna won full FDA approval for its Covid, which could signal a slow regulatory process ahead. Moderna completed its submission back in late August, but didn’t receive approval until this week, five months later.
Novavax’s filing, first promised in the third quarter of last year, has been repeatedly delayed by the company’s struggles to manufacture doses with the consistency regulators demand. Depending on the FDA’s sense of urgency, Novavax’s vaccine may not be available until the summer, a full year after it charted 90% efficacy in a Phase 3 trial.
Read more. | NASH data doesn’t move markets like it used to Yesterday, Madrigal Pharmaceuticals said its drug significantly reduced liver fat half without any serious safety issues, meeting the goal of a trial in the fatty liver disease known as NASH. And then Madrigal’s stock price hardly budged.
As STAT’s Adam Feuerstein reports, the data, while positive, are less important than the results of an impending Phase 3 trial that will determine whether Madrigal’s drug can effectively treat the fat deposits and liver scarring that are hallmarks of NASH.
The muted response might signal that NASH, once perceived as a pharmaceutical goldmine, might have lost some luster in the minds of investors. The FDA rejected a NASH drug from Intercept Pharmaceuticals in 2020, and clinical trial setbacks have derailed similar programs at Gilead Sciences, Genfit, and AbbVie.
Read more. | More reads - In the region’s booming biotech industry, workers are in short supply. Boston Globe
- The Karikó problem: Lessons for funding basic research. STAT
- Flight from risk drives biotech stocks to worst start since 2016. Bloomberg
- China to strengthen anti-monopoly efforts in pharma industry. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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