biotech
Paul Stoffels to step down as Galapagos CEO
Andrew Harnik/AP
Beleaguered Belgian biotech Galapagos said yesterday that its CEO, Paul Stoffels, plans to retire upon the appointment of his successor in the next year.
Stoffels, a longtime drug developer at Johnson & Johnson, took over leadership of Galapagos in 2022, aiming to help orchestrate a turnaround after the biotech, which aimed to develop a range of drugs from scratch, suffered a string of study failures and regulatory setbacks. In the past several years, Galapagos has been a source of fascination for the industry, and some investors were hoping for a massive comeback.
Earlier this year, though, Galapagos underwent a major restructuring. It said it would split itself into two companies, with the brand-name biotech focusing on cancer cell therapies, while the spinoff would build up a pipeline through transactions.
Galapagos also announced yesterday that Henry Gosebruch, most recently the CEO of neuroscience biotech Neumora, would be the CEO of the spinoff company.
obesity
Novo submits oral version of Wegovy for approval
Novo Nordisk submitted the oral version of its obesity drug for FDA approval earlier this year, nearly two years after it reported positive late-stage results of the treatment, the company told STAT.
Novo already has an oral version of its diabetes drug Ozempic on the market (sold under the brand name Rybelsus) that goes up to 14 mg. The oral obesity version would be sold up to a higher dose of up to 25 mg.
In a Phase 3 trial, patients who took an even higher dose of 50 mg lost 15% of their weight over 68 weeks, an amount of weight loss similar to what's seen with injectable GLP-1 drugs. Selling such a high dose would require significant amounts of active pharmaceutical ingredient, though, and Novo put off submitting the treatment for approval since its injectable medications were encountering repeated shortages.
Novo's oral products are peptides that require large dosages in order for patients to be able to absorb enough medication to experience weight loss effects. Meanwhile, other companies, notably Eli Lilly, are developing small molecule obesity drugs that are much easier and cheaper to manufacture.
health
Coverage of preventive services seems likely to be upheld
The Supreme Court appears likely to uphold a provision of the Affordable Care Act that requires coverage of preventive care like cancer screenings, statins to prevent heart disease, and HIV-prevention drugs.
The case came before the Supreme Court yesterday after a lower court sided with Christian employers who argued they can't be can't be forced to cover things like HIV-prevention drugs. Most of the Supreme Court justices, though, appeared to side with the federal government, which was defending the mandate, the Associated Press reported.
A ruling is expected by the end of June. Read more.
Meanwhile, STAT published an opinion piece this morning from Jeff Levin-Scherz, a managing director at WTW who consults for large employers. He argues that employers should continue to cover preventive services regardless of how the Supreme Court rules. Read more of that here.
oncology
Gilead therapy may help with aggressive form of breast cancer
Gilead reported yesterday that a combination of its cancer drug Trodelvy and Merck's Keytruda delayed the growth of tumors in women with an aggressive form of breast cancer.
In patients with the disease — metastatic, triple-negative breast cancer — the combination of Trodelvy and Keytruda demonstrated a "clinically meaningful" improvement in progression-free survival compared to Keytruda plus chemotherapy, Gilead said, but it did not disclose detailed results.
Overall survival, a key, secondary endpoint of the study, is trending in a favorable direction, but the data are not yet mature, the company said.
Read more from STAT's Adam Feuerstein.
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