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Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.
The Phase III clinical trial showed a noticeable placebo effect compared with OV101.
The big winners of the night were AstraZeneca and Roche as pharma, biotech and allied industries came together online on 2 December to celebrate during a ceremony hosted by Ed Balls.
Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.
With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.
A lower first dose boosted the vaccine’s efficacy result – but AstraZeneca has conceded this has to be proven in a separate trial.
SK set for Korean trial with vaccine, as Biological E begins human trials of Baylor vaccine. Meanwhile, DongWha gets a Phase II nod for potential drug, and Celltrion progesses with Phase II regdanvimab trial.
Another disappointment for irritable bowel syndrome therapies as Urovant Science’s vibegron fails in a Phase II trial, likely spelling the end for the investigational indication.
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