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.
Sesen’s corporate spin amounts to nothing
According to Sesen Bio Vicineum was a shoo-in for US approval this month. What went so badly wrong?
Bluebird exits Europe as another hold hits
The business split is still on, but problems mount for the genetic disease wing of Bluebird.
Europe approves a Covid-19 crystal ball
Memed claims that its newly CE-marked test can predict Covid-19 severity.
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”.
Panel puts Fibrogen project to an almost certain death
An FDA advisory committee refuses to overlook the potential dangers of roxadustat, Fibrogen's novel anaemia pill, leaving partner Astrazeneca with a difficult…
After the Aduhelm euphoria, reality bites
The practicalities of actually selling the controversial new Alzheimer’s drug are proving increasingly difficult for Biogen.
Transmedics panel defies expectations
A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
Narrowed label for Biogen’s Aduhelm lays bare FDA’s fail
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.
