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While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
But results of the re-analysis of three HAE treatments aren’t necessarily expected to be typical for RWE-based updates undertaken in the future by the Institute for Clinical and Economic Review.
Novavax said it would start shipping supplies of its vaccine to Europe starting in late 2021, while Vaxart delayed the start of its Phase II study due to issues with Emergent BioSolutions. Meanwhile, Roche India received an EUA for Regeneron's antibody cocktail