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Scrip surveys the Phase III clinical trial readout landscape and picks 10 of the more interesting studies set to report in 2023, with a few added extras. AstraZeneca, Novo Nordisk, Novartis and Roche feature heavily.
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
The Swedish firm’s Parkinson's disease drug has failed to hit its primary endpoint in a Phase IIb study but Irlab believes that positive results on secondary goals merit further development of mesdopetam.
President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.
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