PK Evaluation In Pregnancy: Can HIV Show A Way Forward?
US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.
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Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.
In her first address as CEO, Emma Walmsley has shocked the market with a long list of changes for GSK, including a total makeover of the group's pharma unit. As a result, more than 30 R&D programs will be getting the axe and a 2011 commercialization partnership with Johnson & Johnson is on its way to the gallows.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker