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.
The overall rate of device approvals in 2019 is holding steady on last year – but the types of approvals are different.
Positive data, toxicity, a US FDA delay and the early leaking of information culminate in a green light for the multiple myeloma drug.
Astrazeneca hopes that its new COPD triplet can gain share from Glaxosmithkline’s rival, but it is not planning a price war.
Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
The US FDA granted seven approvals in two days last week, including an eagerly awaited thumbs-up for Novartis’s gene therapy Zolgensma.
Pfizer opts not to start a price war with Alnylam and Ionis, but could there be a pricing loophole?
Payment of an overdue $120m Astrazeneca milestone, plus two other obligations, has been met through a loan facility with undisclosed terms.
Astrazeneca gets one over on Sanofi and Lexicon with European approval for Forxiga. US regulators might not be so forgiving.