Another strike for biotech: China
Use of an auditor that cannot be inspected by the US regulator takes centre stage as Chinese biotech stocks fall.
How China applicants could avoid the sintilimab scenario
A US adcom savages sintilimab, but the biggest problems identified might be sintilimab-specific.
Biogen hints at jobs cuts unless government pays up
An analyst call over the Aduhelm coverage debacle sees Biogen threaten more cost cutting.
Aduhelm verdict puts the heat on Biogen – and on the FDA
The US Centers for Medicare & Medicaid Services’ national coverage determination for Biogen’s Aduhelm makes for uncomfortable reading.
Your 2022 wildcard predictions revealed
Could Aduhelm be pulled? Will Incyte get acquired? Here are some of your wildest New Year predictions.
Roxadustat shows the latest regulatory fault line split
Fibrogen’s controversial anaemia pill becomes the latest example of markedly different regulatory stances taken in Europe and the US.
The moral battle lines are drawn in Alzheimer’s
Biogen goes on the offensive against “misinformation” and a media assault, but Roche says patients want clinical benefit, “not imaging”.
After the Aduhelm euphoria, reality bites
The practicalities of actually selling the controversial new Alzheimer’s drug are proving increasingly difficult for Biogen.
