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.
Last year’s new medicines reveal strong commercial promise and some novelty
The commercial potential of last year’s new medicines suggests another strong year of productivity from biopharma, while a further analysis reveals the arrival of two…
Approvals of high-risk devices drop as de novos take off
Changes at the FDA have altered the device approval landscape, with the de novo route now the most popular.
Topping 2018 drug approvals will be a tall order
Was 2018 as good as it gets for drug approvals, or is the pipeline so stellar that even a US government shutdown cannot stop biopharma?
Pharma news over the Christmas period
If the recent performance of biotech stocks prompted you to pull down the shutters until the New Year celebrations subsided here’s what you might have missed.
Ash 2018 – Sobi still has a mountain to climb with Gamifant
Launch could be trickier than approval, not least because of problems diagnosing patients with primary haemophagocytic lymphohistiocytosis.
Kickstarting ideas
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