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What’s in Today’s Brief? (February 8th Preview)
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Hims halts compounded Wegovy amid federal pressure
Hims & Hers stopped offering a compounded version of Novo Nordisk’s Wegovy after escalating legal pressure from federal regulators and calls for criminal review. The company said it “decided to stop offering access” following warnings from the FDA and renewed scrutiny over unauthorized compounding of approved GLP‑1 products. Regulators including the Department of Justice have been urged to investigate firms selling unapproved, compounded versions of branded GLP‑1 drugs; the developments mark a sharp enforcement turn as demand for obesity medicines surges. Industry lawyers and brand manufacturers have argued that mass compounding of approved therapies undermines drug safety and intellectual‑property protections. For companies in telehealth and compounding, the episode signals heightened regulatory risk and potential legal exposure when repackaging or compounding high‑demand branded agents. Biotech and pharma firms that supply proprietary GLP‑1 molecules face parallel commercial and legal pressures as new entrants test the boundaries of compounding and secondary manufacturing.
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PLpro and RIPK1 inhibitors synergize against SARS‑CoV‑2 in mice
Researchers reported that combining inhibitors targeting SARS‑CoV‑2 papain‑like protease (PLpro) with host RIPK1 inhibitors produced potent, synergistic antiviral effects in a mouse COVID‑19 model. The team published preclinical results showing combination therapy reduced viral loads and improved survival compared with single agents. The report, appearing in Acta Pharmaceutica Sinica B, indicates dual targeting of viral proteases and host inflammatory kinases can both suppress replication and blunt pathogenic host responses. The compounds demonstrated favorable safety signals in the small‑animal study but remain preclinical. The finding suggests a two‑pronged antiviral strategy—direct antiviral plus host‑directed immunomodulation—could extend therapeutic choices against variants that partially escape current direct‑acting antivirals. Companies developing PLpro inhibitors or RIPK1 modulators may find routes to rapid combination development, but translation will require detailed toxicology and human efficacy trials.
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Brepocitinib clears proof‑of‑concept — Roivant advances to pivotal testing
A proof‑of‑concept study showed brepocitinib, a dual JAK1/TYK2 inhibitor licensed by Priovant (a Roivant subsidiary) from Pfizer, met endpoints in cutaneous sarcoidosis, a rare inflammatory skin disease with no FDA‑approved treatments. The company said the result positions the asset for pivotal testing. The readout supports brepocitinib’s potential in rare immune‑mediated dermatologic indications; Roivant’s licensing strategy aims to accelerate development by pivoting licensed molecules into underserved rare‑disease markets. The study’s details—patient numbers, effect sizes, and safety signals—will be central to regulatory strategy and pivotal trial design. If regulators accept the planned pivotal program, brepocitinib could move toward registration and broaden Roivant’s pipeline of speciality immunology assets, creating commercial potential in orphan indications where unmet need and pricing dynamics differ from larger autoimmune markets.
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Sanofi dissects failed tolebrutinib PPMS study — company retreats
Sanofi disclosed data from a failed Phase 3 trial of the BTK inhibitor tolebrutinib in primary progressive multiple sclerosis (PPMS), an outcome that prompted the company to step back from the indication. Investigators and Sanofi reviewed subgroup and biomarker findings to understand drivers of the negative readout. The company’s presentation at ACTRIMS26 unpacked potential explanations—trial design, patient selection, or insufficient target engagement in PPMS—and highlighted the difficulty of translating BTK biology into progressive MS outcomes. Sanofi’s withdrawal underscores the high technical and clinical risk in neuroinflammation and progressive neurodegenerative endpoints. For BTK developers and investors, the episode emphasizes the importance of indication‑specific biology and robust biomarker strategies; companies will likely revisit dosing, CNS exposure metrics, and adaptive designs before pursuing progressive MS programs.
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ARPA‑H trims commercialization staff amid restructure
ARPA‑H cut staff tied to commercialization and operations, according to multiple sources, shedding roles meant to move funded technologies toward market. The agency confirmed layoffs but said scientific programs remain intact; roughly 20 positions were reported affected. Sources told STAT the cuts concentrated on operational and tech‑to‑market functions rather than scientific staff. ARPA‑H was set up to accelerate high‑risk, high‑reward biomedical innovations; reductions in commercialization personnel could slow translational handoffs and industry partnerships. The moves arrive as federal biomedical funding priorities and oversight evolve; prospective awardees and industry partners will watch closely for signals about ARPA‑H’s capacity to shepherd projects from lab to clinic.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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