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Among other Asia deals, Takeda adds to pair of recent gene therapy tie-ups with a CNS-focused cell therapy partnership with Immusoft; earlier it licensed ex-US rights to JCR’s Hunter syndrome drug.
Two Indian firms want to terminate specific Phase III trials for molnupiravir, the Merck/ Ridgeback Biotherapeutics’ antiviral in the spotlight as a treatment for mild-to-moderate COVID-19. Should much be read into these plans or is it merely an “administrative closure” that is being sought?
Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.
The availability later this month of Hetero's biosimilar tocilizumab, ostensibly a less pricey product, could place India in a relatively better situation to cope with any demand spurt should another wave of COVID-19 strike. Innovator product Actemra is expected to be in short supply, going by current trends, given the unprecedented worldwide demand.
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