| | | |   | It's Meghana here, with some help from Adam regarding the Lilly drug that didn't pass FDA muster, as well as from Matt, on how Jim Allison's name shall be emblazoned on a new M.D. Anderson immunotherapy center. | | | FDA rejects Lilly drug that’s only been tested in China In what is probably the least surprising decision ever handed down by the Food and Drug Administration, the agency yesterday rejected a lung cancer immunotherapy from Eli Lilly and its partner Innovent Biologics.
In February, the FDA’s top cancer regulator, Rick Pazdur, and a panel of outside experts shredded Lilly and Innovent for conducting the drug’s clinical trial entirely in China, thus sending a blunt warning to other drug makers thinking of doing the same. Yesterday's rejection might have been a fait accompli but it was also a reminder that Pazdur once embraced the entry of Chinese-developed cancer drugs to the U.S. — until he changed his mind. Lilly and Innovent could try again, but re-submitting to the FDA won’t happen without an entirely new “multi-regional” clinical trial that compares its drug, called sintilimab, directly against another currently approved lung cancer immunotherapy. To make a head-to-head study like that work would require thousands of patients and years to complete — something the pharma industry rarely wants to do. Lilly and Innovent already sell sintilimab in China, where it’s been approved. As for future U.S. plans, the companies said yesterday they are “assessing next steps.” | Google AI’s approach to health care Greg Corrado, director of health AI at Google, understands that technology must be designed to carefully integrate into existing medical systems. The tech mantra “move fast and break things" simply doesn’t apply to health care, he told STAT. “That’s one of the pieces of humbleness I want the organization to project,” he said. Corrado is working to develop technology that can be used by regular camera phones, rather than specialized machines, to detect diseases like diabetic retinopathy. Another approach his team is working on is refining algorithms to detect fetal anomalies in pregnant women, captured on portable ultrasounds. The idea is to improve access to better maternal care in low- to middle-income countries. Read more. | 2022 STATUS List: The most definitive and consequential accounting of leaders in health, medicine, and science Meet the STATUS List — 46 individuals shaping the future of their fields. Drawn from sectors including biotechnology and diagnostics, as well as broader arenas like education and policy, each individual has taken extra steps to help others and build community in these often-divisive times. Explore the list. | Pricing negotiations help in Germany, Switzerland Between 2009 and 2020, cancer drug prices rose substantially in America. In that same time period, according to a new study, the cost of those exact medications either decreased or didn’t exceed inflation in both Germany and Switzerland — countries whose governments negotiate pricing with manufacturers. “One would expect that if you have more competition — there were multiple drugs for each form of cancer — that prices may decline. But not in the U.S.,” the study’s coauthor said. “Given all the discussions regarding prices and negotiations, you can see these are very different outcomes in Switzerland and Germany, which are also two major pharmaceutical markets.” Read more. | Are Covid-19 vaccines a sustainable business? Was Aduhelm an aberration? And what comes after Omicron? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Senior writer Helen Branswell joins us to discuss the latest twists in the pandemic, including rising case counts, next-generation vaccines, and the latest data from pediatric trials. We also dive into the latest news in the life sciences, including Moderna’s grand ambitions, Al Sandrock’s new job, and the next big FDA debate. Read more. | How Jim Allison’s name got on a new institute Yesterday morning, M.D. Anderson Cancer Center announced the creation of the James P. Allison Institute, which will hire roughly 125 scientists and staff in order to better understand how to extend the gains of immunotherapy cancer treatments.
How does that feel to Allison, who won a Nobel for his immunotherapy work? “It’s embarrassing,” he told STAT. But having his name on the door, he said, makes him want even more to succeed.
The new institute came out of discussions he had with M.D. Anderson President Peter Pisters. Because it has both scientists and patient volunteers, he said, the cancer center could play a unique role by doings studies that combine immunotherapy with other treatments like chemotherapy and radiation and make intelligent combinations of what works best. “All these other trials to me are just offensive because they’re going to fail,” Allison said. “People are expecting a home run but they’re not willing to take singles or doubles.” | More reads - Roivant Social Ventures teams up with San Diego drug discovery center to bolster diversity in biopharma. (FierceBiotech)
- Celsius Therapeutics heats up with $83 million and an IBD drug on path to the clinic. (MedCity News)
- Moderna wants to give FDA ‘flexibility’ in deciding eligibility for 4th Covid shot, CEO says. (CNBC)
| Thanks for reading! Until next week,  | | | |
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