Tougher regulatory scrutiny by India amid its massive reliance on such raw materials from China is anticipated, but the current Indian inspection action is just 'normal regulatory duties,' a Shanghai-based regulatory officer said.
India is said to have issued show-cause notices over quality concerns to certain Chinese firms which supply active pharmaceutical ingredients (APIs).
The action, which follows inspections at the Chinese sites by the Indian regulator last year, is aimed at clamping down...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
