Speedy nod sets Alnylam up for its second launch
Alnylam unveils a novel pricing strategy for its second RNAi launch, which was greenlit by the US regulator with notable speed.
Diagnostics specialists win the US device approval race
The speediest device developer is Roche, but a look at companies’ strategies shows the perils of relying on bought-in tech.
Vertex’s double cystic fibrosis surprise
The remarkable speed of the company’s cystic fibrosis triplet approval will not distract attention from its price.
Pricing questions remain as Novo gets the nod for oral sema
Novo Nordisk says that oral semaglutide’s list price will be “similar” to Ozempic’s, but it will be a while before its true cost becomes apparent.
Bayer could become the latest casualty of Roche’s targeted pricing
Roche’s lower price tag for its targeted cancer therapy Rozlytrek could – intentionally or not – hit one of Bayer’s big hopes hard.
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.
Kickstarting ideas
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