Go or no go? The FDA’s Amylyx dilemma
June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.
Glaxo gets a Shingrix boost
But pressure is on the shingles vaccine as the consumer spin-off approaches.
Sanofi scores a win with long-acting haemophilia project
Interim results on bleeds look impressive, but more data are needed to gauge efanesoctocog alfa's chances against Roche's Hemlibra.
Go or no go? Bristol’s Lag3 debut
March Pdufa dates are set for relatlimab as well as Akebia’s vadadustat, while Amylyx’s ALS drug heads for a panel.
Imara gets a second shot in sickle cell
Will upping the dose and changing the primary endpoint pay off?
