| |   | Good morning, all. Damian here with the inside story on a modern pharmaceutical coup, a preview of biotech's next big binary, and a remembrance of blowups past. | | | How Paxlovid went from a faded memory to Covid breakthrough While Pfizer’s vaccine scientists made global headlines with a dramatically effective way to prevent Covid-19, a dedicated group of company researchers were toiling on an arguably thornier project: How do you keep infected patients from getting hospitalized and dying?
They came up with Paxlovid, an oral treatment developed in record time with efficacy that promises to help get the pandemic under control. As STAT’s Matthew Herper reports, their success was hardly assured, and the story of Paxlovid involves digging through Pfizer’s institutional memory, sprinting to understand a novel virus, and screening hundreds of potential drugs in search of the one that could safely combat it.
For Charlotte Allerton, Pfizer’s head of medicine design, that all culminated with a November phone call from the company’s top scientist, relaying the best news imaginable: Paxlovid led to an 89% reduction in the risk of hospitalization or death. But the work of getting the drug to patients was only beginning.
Read more. | The next big biotech readout will move billions in market cap The fortunes of four companies are riding on whether Alnylam Pharmaceuticals can succeed in what might be 2022’s most scrutinized clinical trial, and data should be available this summer.
Analysts on Alnylam’s quarterly earnings call, scheduled for 8:30 a.m. ET today, will likely focus on APOLLO-B, a Phase 3 trial testing whether the company’s approved drug Onpattro can significantly improve the lives of patients with an increasingly common heart disease called ATTR-CM. If Onpattro works, Alnylam’s stock price could skyrocket. If it doesn’t, the company could lose billions in value, further dragging down the beleaguered biotech sector.
Late last year, scientists and investors alike were shocked when a rival treatment from BridgeBio failed to beat placebo in a one-year study enrolling ATTR-CM patients. APOLLO-B is a similar trial, and while Alnylam’s drug is substantially different from BridgeBio’s, investors will be looking for assurances that Onpattro won’t similarly disappoint. The result will also affect Intellia Therapeutics and Ionis Pharmaceuticals, each of which is at work on therapies for ATTR-CM. | May 24 | The STAT Health Tech Summit Join us virtually, or in San Francisco, as we convene experts from Amazon Lab126, Ascension, Google Health, and more to discuss the next big innovations in health tech. We’ll cover everything from patient data to AI to telemedicine. Learn more at statnews.com/summit. | Are there second acts for disgraced biotechs? Two decades ago, Biopure was a fledgling company with a human blood substitute and an idiosyncratic relationship with the truth. The story ended with SEC charges, corporate bankruptcy, and a prison sentence for one executive.
Or at least that’s how it seemed to end. As STAT’s Adam Feurstein reports, Biopure is back, with new management and a new name but the same human blood substitutes that never quite managed to work in the 2000s.
Read more. | Moderna puts the ball in FDA’s court Moderna has filed its Covid-19 vaccine for authorization in kids under the age of 5, the company said this morning, adding to the mounting pressure on the FDA to make a decision that would affect millions of families in the U.S.
Moderna’s application is based on data showing kids who received two doses of the company’s vaccine generated antibodies at a level comparable to adults. When it came to preventing Covid-19, the vaccine was 51% effective in children under 2 and 37% effective in kids between 2 and 6.
Meanwhile, the Biden administration is apparently on the fence about just how to deal with Covid-19 vaccines for young children. Last week, Politico reported the FDA is considering holding off on reviewing Moderna’s application until later this summer, when Pfizer will have data from a similar population, and then authorizing the two at the same time. The notion has enraged some parents, who have long been pressuring the agency to quickly authorize any Covid-19 vaccine for their kids. | More reads - Solid Bio lays off 35% of workforce; chief operating officer plans exit. FierceBiotech
- BridgeBio's chief strategy officer resigns as the company quietly embarks on another round of layoffs. Endpoints
| Thanks for reading! Until tomorrow,  | | | |
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