Oscient Pharmaceuticals Corporation
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Latest From Oscient Pharmaceuticals Corporation
Deal Watch: Moderna, Immactics Team Up To Combine mRNA Technology With Cancer Cell Therapy
Plus deals involving Kelun Biotech, Pierre Fabre/Vertical, Novo Nordisk/Broad Institute, ABL Bio/Synaffix, Kriya/Tramontane, Palisade/Giiant and more.
US FDA’s Breakthrough Designation Pace Slows, But Topics Broaden
The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
FDA Turns Down F2G’s Antifungal, But Firm Plots Comeback As Trial Completes Accrual
The US regulatory agency asked for more data and analyses for olorofim, which F2G hopes to provide from an ongoing Phase IIb study.
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