Positive data, toxicity, a US FDA delay and the early leaking of information culminate in a green light for the multiple myeloma drug.
A delayed decision on Karyopharm’s selinexor is the pick of the bunch for July.
Astrazeneca hopes that its new COPD triplet can gain share from Glaxosmithkline’s rival, but it is not planning a price war.
The recent disappointing sales of drug-coated devices for peripheral arterial disease look likely to become the norm.
More data with voxelotor shouldn’t hurt the project’s bid for accelerated approval, but there are still doubts about its effect on a harder patient outcome.
Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
Approvals for new uses of old drugs should far outweigh nods for novel projects in June.
The US FDA granted seven approvals in two days last week, including an eagerly awaited thumbs-up for Novartis’s gene therapy Zolgensma.
Biogen needs a win with its Tecfidera follow-on, while Kalvista hopes to make HAE where Biocryst failed.