regulatory
FDA approves a second microbiome drug
Seres Therapeutics won FDA approval for a treatment that uses bacteria to treat a bowel disorder, the agency said yesterday, making it the second microbiome therapy to hit the market.
As STAT's Allison DeAngelis reports, the drug, Vowst, is designed to treat recurrent infections of the Clostridium difficile bacteria, which unleashes toxins that wreak havoc on the digestive system. These infections can occur after a person takes antibiotics, which tend to wipe out both good and bad bacteria in the gut, allowing C. diff to take over.
Seres' drug works by introducing beneficial bacteria back into the digestive system. In clinical trials, nearly 90% of patients who took the drug after a C. diff infection were free from recurrence after eight weeks, compared to 60% in the placebo group.
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Research
Early findings in gene therapy death suggest CRISPR was not the cause
Months after the 2022 death of a patient in the first designer CRISPR trial, researchers have concluded that the genome-editing therapy was not the cause.
As STAT's Jason Mast reports, clinicians examined the case of Terry Horgan, who died eight days after receiving a CRISPR therapy meant to treat his Duchenne muscular dystrophy, and found no traces of Cas9, the central protein used to manipulate the genome, in his tissue. That suggests the CRISPR treatment never had a chance to harm or benefit the 27-year-old.
Horgan's therapy, developed by a nonprofit his brother founded, had been the first known attempt to use CRISPR to build a custom treatment for a particular mutation that may only affect a small handful of people. Other researchers working on so-called bespoke or n-of-1 approaches using CRISPR could rest assured his death hadn't also revealed a fundamental flaw in the technology itself, experts said, though it still left other questions about how Horgan died and what it means for the future of the ultra-rare disease field.
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Personnel
Bristol Myers CEO stepping down after two decades
Giovanni Caforio, who has spent 23 years at Bristol Myers Squibb, will retire as CEO in the fall, the company said yesterday.
Caforio's eight-year tenure as CEO will end Nov. 1, after which Christopher Boerner, the company's current chief commercial officer, will take over. Caforio will remain executive chairman of the board for an undetermined transition period, the company said.
Bristol Myers nearly tripled its revenue under Caforio's leadership, launching 12 new medicines in the process. He led 2019's $74 billion merger with Celgene, expanding the company's presence in oncology.
Washington
It helps to lead HELP
Sen. Bill Cassidy's newfound spot as the top Republican on the powerful health committee has made him a popular figure among pharmaceutical CEOs.
As STAT's Rachel Cohrs and Sarah Owermohle report, Cassidy received a slew of campaign contributions from drug industry executives about a week after the Louisiana Republican officially became the ranking member of the Senate HELP committee. Among his new benefactors are the CEOs of Pfizer, Eli Lilly, and Biogen, all of whom sit on the board of PhRMA.
Next month that committee, chaired by Sen. Bernie Sanders, is slated to hold a hearing on insulin pricing and mark up legislation regulating pharmacy benefit managers, something the drug industry has been pushing for years.
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