For biotechs nearing regulatory approval the key is to sell before launch. For buyers, playing the waiting game is a better strategy.
October looks to be a big month for label expansions, with Dupixent and Hemlibra both poised to move into big new patient populations. Meanwhile Ionis is awaiting a make-or-break FDA verdict.
Alnylam has secured its first approval, but history suggests that launch will be far from easy.
No slowdown at the FDA, as regulator remains on track to approve at least 43 new drugs this year.