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Fines & Regulatory Issues

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May 16, 2022

Valneva and Synairgen remain Covid laggards

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April 04, 2022

Swift resolution emerges to China's non-compliance

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March 11, 2022

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.

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February 16, 2022

Mirati and the elephant in the room

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February 11, 2022

How China applicants could avoid the sintilimab scenario

A US adcom savages sintilimab, but the biggest problems identified might be sintilimab-specific.

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January 13, 2022

Biogen hints at jobs cuts unless government pays up

An analyst call over the Aduhelm coverage debacle sees Biogen threaten more cost cutting.

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January 12, 2022

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.

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December 23, 2021

Your 2022 wildcard predictions revealed

Could Aduhelm be pulled? Will Incyte get acquired? Here are some of your wildest New Year predictions.

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August 20, 2021

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.

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July 23, 2021

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”.

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July 16, 2021

After the Aduhelm euphoria, reality bites

The practicalities of actually selling the controversial new Alzheimer’s drug are proving increasingly difficult for Biogen.

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