AstraZeneca acquires vaccine startup Omniose. AstraZeneca has acquired Omniose, its vaccine development partner since a January 2024 alliance, for undisclosed terms, BioPharma Dive reported on November 11. The prize is Omniose’s bioconjugation technology, a more efficient way to build the conjugate vaccines used against serious bacterial infections. No price was disclosed, and the deal is a technology bolt-on rather than a pipeline purchase.
Compass Pathways completes psilocybin approval filing. Compass Pathways said it has completed a United States approval application for COMP360, its synthetic psilocybin, in treatment-resistant depression. In clinical testing, six weeks of treatment were associated with an average 3.8-point reduction on a 60-point depression severity scale. The company previously received a special FDA voucher that could speed review, a program whose future is in question after reports this week that the agency is shelving its priority voucher scheme.
Biogen litifilimab shows 52-week skin data in cutaneous lupus. At ACR Convergence, Biogen’s litifilimab continued to improve skin outcomes through week 52 in the Phase 2/3 AMETHYST trial in cutaneous lupus, Healio reported on November 10. Among 93 patients, the share reaching clear or almost clear skin on the CLA-IGA-R erythema measure rose from 19 percent at week 24 to 27.2 percent at week 52 on continuous treatment, and patients switched from placebo caught up, reaching 33.7 percent. The bigger catalyst is separate: litifilimab’s Phase 3 results in systemic lupus are expected by the end of 2026.
FDA review divisions run far below 2024 staffing. The FDA’s two drug review centers, CBER and CDER, employed 1,343 fewer people in September 2026 than in September 2024, according to agency hiring data cited by PharmaVoice on November 11, and the agency was working toward roughly 2,200 hires as of June. Lawyers who practice before the agency describe slower, less predictable reviews and the loss of informal feedback channels, costs that fall hardest on small developers with thin cash runways.
Harvard study says German price rises would lift United States costs too. A Harvard Medical School-led study published November 11 modeled the most-favored-nation policy’s feedback loop: a 25 percent increase in German drug prices would add about 6.2 billion dollars to German health insurance spending and, by raising the reference benchmark, about 300 million dollars to United States Medicaid spending. The analysis was supported by Germany’s statutory health insurance association, which opposes the price pressure; the researchers said they had full control of the study.
All of Us finds thousands of new drug-response variants. A study of nearly 100,000 participants in the National Institutes of Health’s All of Us program, published November 11 in Science Translational Medicine, identified thousands of previously unrecorded variants across 16 pharmacogenes. Every participant carried at least one variant, and one in four had taken a medication the variants could affect, including antidepressants, statins and the blood thinner Plavix. The program’s funding is set to fall to an expected 122 million dollars, an 80 percent drop from its 2023 peak, which has already forced cuts to recruitment and to returning genetic results to participants.