MabVax Therapeutics Holdings, Inc.
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Latest From MabVax Therapeutics Holdings, Inc.
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.
Genentech will use the X-Chem platform to obtain leads against multiple oncology targets. Lilly partners with Merus on CD3-targeting T-cell therapy candidates.
After manufacturing issues disrupted a Phase III study for its lead pipeline candidate, Pharnext believes it is back on track with new management, a fresh clinical trial and strong guidance from regulators. New CEO David Horn Solomon has blockbuster expectations for the company’s rare disease drug.
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