regulatory

News

FDA starts a priority review of Bayer's Kerendia for chronic kidney disease in type 1 diabetes, which could end a 30-year drought in new therapies.

News

LSE pharma policy expert contends the MHRA/NICE aligned pathway is weighted towards industry, and calls for an assessment of its impact on the NHS.

R&D

As increasing global competition from incentives is felt globally, Ireland needs to become even more agile.

Market Access

Unlocking the potential of novel medicines for Europe’s patients demands innovation beyond invention.

R&D

A review of the scope, key principles, methodological expectations, and regulatory implications of ICH E20.

News

Eisai and Biogen are facing a delay in the FDA review of injectable Leqembi for initial dosing in Alzheimer's, viewed as a key growth driver.