Karyopharm rollercoaster ends in selinexor approval
Positive data, toxicity, a US FDA delay and the early leaking of information culminate in a green light for the multiple myeloma drug.
Go or no go? Karyopharm awaits a verdict on selinexor
A delayed decision on Karyopharm’s selinexor is the pick of the bunch for July.
Astra cannot breathe easy despite first triplet approval
Astrazeneca hopes that its new COPD triplet can gain share from Glaxosmithkline’s rival, but it is not planning a price war.
FDA adcom to pronounce on paclitaxel-coated devices
The recent disappointing sales of drug-coated devices for peripheral arterial disease look likely to become the norm.
EHA 2019 – Global Blood faces sickle cell questions
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.
Rewalk Robotics suits up
Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
Go or no go? Merck, Regeneron and Alexion await US expansion
Approvals for new uses of old drugs should far outweigh nods for novel projects in June.
Zolgensma heads up spate of US approvals
The US FDA granted seven approvals in two days last week, including an eagerly awaited thumbs-up for Novartis’s gene therapy Zolgensma.
Upcoming events – key tests approach for Biogen and Kalvista
Biogen needs a win with its Tecfidera follow-on, while Kalvista hopes to make HAE where Biocryst failed.
Kickstarting ideas
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