England, Scotland, Wales and Northern Ireland will publish their respective action plans to deliver the aims of the UK’s new framework for rare diseases.
Improving patient access to innovative drugs is among a raft of aims outlined in a new UK framework for accelerating diagnosis and improving treatment for patients with rare diseases.
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The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.
Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.
Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.
The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.
Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
