Use of an auditor that cannot be inspected by the US regulator takes centre stage as Chinese biotech stocks fall.
A US adcom savages sintilimab, but the biggest problems identified might be sintilimab-specific.
An analyst call over the Aduhelm coverage debacle sees Biogen threaten more cost cutting.
The US Centers for Medicare & Medicaid Services’ national coverage determination for Biogen’s Aduhelm makes for uncomfortable reading.
Could Aduhelm be pulled? Will Incyte get acquired? Here are some of your wildest New Year predictions.
Fibrogen’s controversial anaemia pill becomes the latest example of markedly different regulatory stances taken in Europe and the US.