Key approval decisions in Califf’s first year at FDA; new research raises possibility of universal organs for transplants

Robert Califf, the new FDA commissioner, will have to defend the agency's looming decisions on a slew of controversial drug applications. ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

Sponsored by     STAT+: 6 approval decisions that will make or break Califf's first year at the FDA By Nicholas Florko Andrew Harnik/AP Robert Califf, the new FDA commissioner, will have to defend the agency's looming decisions on a slew of controversial drug applications. Read More By altering the blood type of lungs, researchers raise the possibility of universal organs for transplants By Isabella Cueto University Health Network "It has the potential – and I would underline 'potential' – to expand the donor pool in meaningful ways," said one transplant surgeon. Read More STAT+: Some newly public biotech companies are trading below cash. Is it as bad as it looks? By Kate Sheridan Adobe One in four biotechs that went public in 2020 are trading below cash, according to a new STAT analysis of data. Read More Sponsor content by Legend Biotech Commercializing cell therapy: launching "disruptive" technologies requires innovative strategies Personalized medicine is changing the therapeutic landscape for patients and providers, but creating "disruptive" and highly individualized therapies requires a new approach to commercialization. Steve Gavel, vice president of global commercial development at Legend Biotech, details how Legend, which was incorporated less than a decade ago, created the infrastructure to bring cell therapies to market at an accelerated speed. Read about its approach to commercialization and how it hopes a three-pronged strategy can ensure success. Opinion: Coronaviruses are 'clever': Evolutionary scenarios for the future of SARS-CoV-2 By Donald S. Burke NIAID SARS-CoV-2 could become endemic. The known playbook of coronaviruses shows that its evolution could also send it in other directions. Read More STAT+: Toxic levels of pharmaceuticals threaten the health of the world's rivers By Ed Silverman Jeff Swensen for STAT The most contaminated sites were located in low-to-middle-income countries, where wastewater management is often inadequate. Read More STAT+: BioNTech details new plans for Covid-19 vaccine production in Africa, but meets with skepticism By Ed Silverman Michael Ciaglo/Getty Images BioNTech detailed new plans to scale up Covid-19 vaccine production in Africa, which are being met with some skepticism. Read More STAT+: Sage study shows rapid anti-depressant effect of experimental pill By Adam Feuerstein APStock The company intends to use the results from the study to help position zuranolone as an “episodic” treatment. Read More STAT+: A federal appeals court once again casts doubt on 'skinny labels' and generic drug access By Ed Silverman Adobe A federal appeals court has once again cast doubt on "skinny labels" and more broadly, access to generic drugs. Read More Wednesday, February 16, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser