| | | |   | Good morning, everyone. Damian here. Today we've spared you enduring an all-day FDA pile-on and a 31-page defense of Aduhelm. | | | FDA has a message for U.S. companies and their Chinese partners The FDA has bad news for the nearly two dozen U.S. drugmakers hoping to win FDA approval for Chinese-developed drugs: Data from trials conducted entirely overseas will not be sufficient to win over regulators.
As STAT’s Adam Feuerstein reports, that was the takeaway from an often bruising all-day review of sintilimab, a checkpoint inhibitor for lung cancer that Lilly Eli and its Chinese partner Innovent want to bring to the U.S.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, and his lieutenants spent hours picking apart the supporting evidence, ruling that data generated entirely from Chinese patients was not “generalizable” to a more diverse population of Americans and citing a 2016 report about clinical trial fraud in China to question the veracity of the sintilimab results.
Read more. | Biogen tries to drive a hole through Medicare's Aduhelm proposal Biogen yesterday submitted its first public comments on Medicare’s proposal to severely restrict access to its Alzheimer’s drug, Aduhelm. And while the company made no secret of its displeasure about that “arbitrary and capricious” proposal, it advanced a plan of its own.
Medicare had previously said it needed more information about Aduhelm’s efficacy and safety and, as a result, would only pay for the drug for patients enrolled in clinical trials. In response, Biogen said it had another idea: It would get Medicare the extra data it wants — not through the traditional trials Medicare is proposing, but instead with speedier real-world evidence.
That offer, as STAT’s Nicholas Florko points out, puts Medicare officials in a difficult position: They can choose to finalize their initial proposal, which would likely see them waiting years for the data they’re looking for, or they can accept Biogen’s offer and collect more data much sooner.
Read more. | Patients want change; providers agree — we need to disrupt the status quo Inequities within the U.S. healthcare system are worsening for medically disenfranchised patients. Genentech believes sustainable solutions require a deeper understanding of their experiences. We surveyed underserved patients and their healthcare providers to learn more about their perceptions of and experiences with the healthcare system. See what they had to say here. | Does Big Science have a bullying problem? Why did the FDA change its tune on China? And what’s cooler than $100 billion?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We discuss the scandalous end of Eric Lander’s tenure as presidential science adviser with STAT Washington correspondent Lev Facher and science writer Megan Molteni. Then we dive into the FDA’s about-face on cancer drugs developed in China and what it means for the cost of medicine in the U.S. We also explain how Pfizer’s record-setting year somehow disappointed Wall Street and explore whether it’s a good idea to end mask mandates.
Read more. | Teenagers could be Novavax’s way into the Covid vaccine market Novavax, plagued by repeated delays for its Covid-19 vaccine, is poised to enter a crowded U.S. market if and when it wins authorization later this year. But positive new data suggests the company might be able to make commercial inroads with the nation’s teenagers.
In a trial enrolling more than 2,000 kids between 12 and 17, Novavax’s vaccine met its primary endpoint of matching the immunological response seen in adults, the company said yesterday. And while there were few cases of Covid-19 in the trial, the vaccine showed 79.5% efficacy against illness. On the safety side, the trial was too small to identify whether the vaccine could trigger a rare heart side effect seen in this age group with the mRNA vaccines, but Novavax said it has seen no imbalance of myocarditis cases in people 18 or older who have received its vaccine.
That latter point could become the company’s sales pitch. The risk of heart inflammation, however remote, has made parents wary of giving their low-risk teenagers mRNA vaccines. If Novavax can position its vaccine as an effective tool for preventing Covid-19 with a more manageable safety profile, it might yet play a role in the U.S. pandemic response.
| More reads - Conflicting reports raise questions about whether any monoclonals work against Omicron’s sister variant. STAT
- Senate pushes toward a vote on Robert Califf, Biden’s pick for FDA. STAT+
- AstraZeneca sees higher 2022 sales even as Covid boost wanes. Reuters
- Pharma’s global productivity is rising, with China accounting for a larger share. STAT+
| Thanks for reading! Until next week,  | | | |
No comments