Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is marshmallow magic. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
Sanofi flagged another delay to a U.S. regulatory decision for its experimental multiple sclerosis drug and reported disappointing results from a late-stage study, Reuters writes. The U.S. Food and Drug Administration decision on its tolebrutinib drug to treat non-relapsing secondary progressive multiple sclerosis will push beyond the action date of Dec. 28, a second delay to a decision that was initially expected in September. The company expects further guidance from the FDA by the end of the first quarter of 2026. Analysts said the setbacks could undermine confidence in Sanofi’s pipeline of new drugs after weak results of its experimental drugs for eczema and smoker’s lung reported earlier in the year. The drugmaker is under pressure to diversify its growth beyond the blockbuster asthma drug Dupixent.
A new kind of oral antibiotic to treat gonorrhea won FDA approval, the second time in two days that a new drug for the common sexually transmitted infection has come through licensure, STAT tells us. Neisseria gonorrhoeae, the bacterium that causes gonorrhea, has for decades been evolving to evade the antibiotics used to treat it. The current standard of care — an intramuscular injection of ceftriaxone — is the last antibiotic to reliably treat the infection, and increasingly treatment failures are being reported. Zoliflodacin, which will be marketed under the name Nuzolvence, is the first new drug to uniquely target gonorrhea infections in decades. The treatment is also the first developed as part of a public-private partnership — Innoviva and the Global Antibiotic Research and Development Partnership, GARDP, a not-for-profit organization.
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STAT Pharma: The science and business of new drug development
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