Pharma execs wrestle with 'nightmare' digital biomarker efforts; how an upcoming SCOTUS case could make the FDA slower

Taking stock of the drug industry, from the lab to the medicine chest

May 17, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

ROBYN BECK/AFP via Getty Images Federal judges question FDA authority in abortion pill hearing A federal appeals court heard opening arguments Wednesday in a case that could determine the future of the abortion pill mifepristone. By Sarah Owermohle STAT+ | Biotech and pharma execs wrestle with the 'nightmare' of developing digital biomarkers The impact of wearables clinical trials for drugs remains largely hypothetical, in part because digital biomarkers are difficult to develop. By Mario Aguilar STAT+ | Could an upcoming Supreme Court case make the FDA slower? The FDA could take longer to write regulations and make decisions if the U.S. Supreme Court rules against a long-standing legal doctrine. By John Wilkerson Adobe STAT+ | A new startup looks to turn the workhorse of gene therapy against cancer AAV viruses have long been used to shuttle genes into patients with genetic diseases. A new startup wants to use them to tackle cancer. By Jason Mast STAT+ | PTC Therapeutics's PKU drug succeeds in trial, but bigger hurdles for company are ahead In PKU, patients can't break down the amino acid phenylalanine, resulting in intellectual disability, memory problems, and other issues. By Matthew Herper STAT+ | CVS Health to close clinical trial unit two years after launch CVS is still recruiting patients for five active trials, including studies focused on rheumatoid arthritis, kidney health, and narcolepsy. By Alexa Gagosz — Boston Globe

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