Regulatory developments over the Christmas period
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.
An expensive new haemophilia gene therapy hits the US
The approval is good for CSL, and better for Uniqure.
U-turn confirms that the US cut-price oncology model is dead
EQRX tears up plans to challenge US PD-(L)1 players on price, and switches focus to two non-discounted small molecules.
FDA scrutiny now hits Parp inhibitors
A November adcom could decide whether Zejula will lose yet more ground to Lynparza.
Go or no go? GSK takes its turn with a novel anaemia class
Amicus and Astrazeneca have notable approaching Pdufa decisions, while a panel for GSK’s daprodustat could change the course of a controversial drug class.
