| | | |   | Hope you had a delicious few days, and welcome back. Today, we share former Merck CEO Ken Frazier's thoughts on his impending retirement, delve into a potential universal vaccine, and more. | | | Ken Frazier reflects on pharma, and on society Former Merck CEO Ken Frazier is retiring as the company’s chairman this week. The storied pharma exec spoke at length recently at the STAT Summit about the drug industry and about democracy — and warned that both are imperiled. “I think our democracy is in danger now,” Frazier said. “If we look at the populist movements on the left and the right, they’re all saying the same thing, which is: You all are being screwed.” His entire interview is worth a read — which is why we’re publishing a largely unabridged version of it. He discusses the industry, the world, and his legacy. “I think we have to think about access. I think we have to think about affordability,” he said. “We can’t make everything available at a very low price, because our investors don’t give us the capital to invest in a very costly, long-term, risky enterprise — R&D. But I think we have to be thoughtful about what society expects from an industry like ours and to ensure that we’re doing responsible things around pricing.” Read more. | A universal flu vaccine? In animals, anyway An experimental flu vaccine modeled after the mRNA shots used for Covid-19 is proving highly promising: Animals study show that it could prompt an immune response that could protect against all known subtypes of flu. If that translates to humans, it could potentially work as a universal flu vaccine. This isn’t to say the vaccine would block all flu infections, nor would it be a replacement for a yearly flu shot. Rather, it would prime the immune system to better respond to new flu variants. The findings, according the study’s lead scientist, suggest the mRNA-based vaccine could imprint in the immune systems of children who hadn’t ever been exposed to the flu with all the flu variants they might face in their lifetimes. Read more. | From months to minutes: the need for speed in real-world evidence generation The process of identifying, acquiring, and evaluating the right real-world data, not to mention converting that data into evidence, is rife with failure and delay. It's time for eClinical innovators to step up with a single, self-service trusted research environment that unites continuously refreshed RWD with a flexible coding environment. Read what that solution needs to deliver, from cohort definition to computational power. | Two neat new CRISPR studies If you missed them during the holiday rush, last week saw the publication of two exciting new CRISPR studies. In the first, a team of researchers at University of Texas Southwestern Medical Center used adenine base editing and prime editing to correct genetic mutations that cause an inherited heart condition called familial dilated cardiomyopathy in human cells and mice. The gene-edited animals had stronger hearts, improved cardiac function, and lived longer than un-treated mice. The second study, from the lab of Omar Abudayyeh and Jonathan Gootenberg at the McGovern Institute at MIT and the Broad Institute, introduced a new genome-editing tool that enables the precise insertion of very large DNA sequences without inducing double-stranded breaks. The researchers used the CRISPR-guided drag-and-drop tool, called PASTE, to insert sequences as large as 36,000 bases into human cells. Keep up to date with all the most exciting clinical developments of the Nobel Prize-winning technology with STAT’s CRISPR Trackr, curated by science reporter Megan Molteni. | FDA votes down Spectrum’s lung cancer drug Spectrum Pharmaceuticals quietly announced Friday that the FDA rejected its experimental lung cancer drug, poziotinib, citing inadequate data. The complete response letter prompted the company to cut 75% of its R&D workers; the company’s shares dropped 13.9% to 37 cents on the news. This isn’t exactly a shock, however — an FDA expert panel recommended against the drug’s approval in September. “Clearly there’s a clinical unmet need for the drug, and the drug has activity, but I don’t know that it has a meaningful improvement over other drugs that, in the real world, are available to patients right now,” one of the ODAC panelists had said. Spectrum now plans to pivot on its other cancer drug, Rolvedon. | More reads - Second death linked to potential antibody treatment for Alzheimer’s disease, Science
- FDA cancels adcomm meeting on BioMarin's hemophilia A gene therapy, BioSpace
| Thanks for reading! Until tomorrow,  | | | |
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