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What’s in Today’s Brief? (February 8th Preview)
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Hims halts compounded GLP‑1 program: Regulators close in
Hims & Hers stopped offering a compounded version of Novo Nordisk’s Wegovy after escalating federal pressure and legal threats. The company said it “decided to stop offering access” to the unapproved product after regulators signaled enforcement, escalating a broader fight over compounding of proprietary GLP‑1 therapies. The episode spotlights tension between telehealth startups seeking rapid market entry and regulators enforcing approved‑drug pathways. Stakeholders include Hims & Hers, Novo Nordisk (owner of Wegovy), and U.S. federal regulators; coverage cites immediate regulatory backlash and legal risk rather than clinical data. For industry participants, the event raises questions about compounding scale, intellectual‑property boundaries and regulatory risk for telehealth formulary expansion.
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Roivant posts proof‑of‑concept win – Brepocitinib eyes pivotal testing
Priovant Therapeutics, a Roivant Sciences subsidiary, reported that brepocitinib—a dual JAK1/TYK2 inhibitor licensed from Pfizer—met endpoints in a proof‑of‑concept study in cutaneous sarcoidosis. The drug now appears on track for pivotal testing in a rare inflammatory skin disorder with no FDA‑approved treatments. The program shift accelerates Roivant’s rare‑disease footprint and positions brepocitinib for potential blockbuster status if larger trials confirm efficacy and safety. The outcome also illustrates how biotech licensing from major pharmas can resurface assets into high‑value orphan indications.
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Sanofi unveils failed tolebrutinib data – PPMS program collapses
Sanofi disclosed detailed results from a failed Phase 3 trial of the BTK inhibitor tolebrutinib in primary progressive multiple sclerosis (PPMS). The company’s presentation at ACTRIMS highlighted why the study missed endpoints and prompted Sanofi to retreat from that particular indication. Investigators pointed to trial design and disease heterogeneity as contributing factors. The disclosure underscores the challenges of translating BTK inhibition into progressive MS and will influence go/no‑go calculus for other BTK programs in neuroimmunology.
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Phage plus antibiotic clears resistant peritonitis in preclinical model
Researchers reported in Nature Communications that combining bacteriophage therapy with antibiotics eradicated refractory Klebsiella pneumoniae peritonitis in a preclinical peritoneal dialysis model. The study led by Yang, Wu and Jiang demonstrated improved bacterial clearance and survival compared with antibiotics alone. The work advances practical phage‑antibiotic combination strategies for multidrug‑resistant infections and provides mechanistic data to support clinical translation. For infectious‑disease and dialysis communities, the results revive interest in adjunctive phage therapy for difficult‑to‑treat, device‑associated infections.
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Inflammasome protein ASC rewires pancreatic cancer metabolism
A Nature Communications study identified the inflammasome adaptor protein ASC as a central regulator linking innate immune signaling to mitochondrial metabolism in pancreatic cancer. Authors Chey, Kashgari and McLeod mapped how ASC alters metabolic pathways that fuel tumor growth. The finding exposes a targetable intersection between immune sensing and cancer bioenergetics and suggests ASC modulation could shift tumor metabolism. Researchers and drug developers may explore ASC‑directed strategies to disrupt pancreatic tumor metabolic dependencies.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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