Novel drug approvals head for a down year
With only 18 novel drugs approved by the FDA so far this year, the influential US regulator looks set to dim the green lights in 2019.
De novo device clearances fall out of fashion
The overall rate of device approvals in 2019 is holding steady on last year – but the types of approvals are different.
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.
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.
Rewalk Robotics suits up
Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
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.
Pfizer shoots for a high price with tafamidis
Pfizer opts not to start a price war with Alnylam and Ionis, but could there be a pricing loophole?
Circassia averts its cash crunch
Payment of an overdue $120m Astrazeneca milestone, plus two other obligations, has been met through a loan facility with undisclosed terms.
Astrazeneca and Lexicon’s type 1 diabetes fortunes diverge, for now
Astrazeneca gets one over on Sanofi and Lexicon with European approval for Forxiga. US regulators might not be so forgiving.
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