Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.
FDA's push to define a regulatory pathway that will encourage development of drugs for single pathogens could be good news for the handful of companies betting on the approach.
The agency is considering a flexible approach to single-species antibiotic development, in line with the agency's flexible position on orphan...
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PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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