Surprise! There’s a tumour in which Keytruda doesn’t work
The Merck & Co drug’s failure in small-cell lung cancer prompts a theory and leaves the way clear for Roche and Astrazeneca.
Clinical developments over the Christmas period
The most important clinical readouts of the holiday period concerned Google Health, Axsome, Wave and Spectrum.
Gene therapy clinical holds take centre stage
An analysis of company disclosures reveals a sharp rise in US FDA-imposed halts on clinical work involving gene therapies.
Biogen stacks the deck but the path forward is no clearer in Alzheimer’s
The presentation of Biogen’s hugely complex aducanumab pivotal programme confirms that the US regulator is destined to make another polarising decision.
Sage advice: psychiatric drug development is tough
As a phase III blow-up brings Sage Therapeutics’ run of success to an end, the company’s post-hoc analyses fail to reassure investors that its depression project has a…
Investors see no end in sight to the misery of hayfever
Twin setbacks for grass pollen allergy projects in development by Asit Biotech and Allergy Therapeutics expose an existential crisis.
Puretech’s cautionary tale about pivotal study read-across
The healthcare company builder Puretech registers one success and one failure, both underlining the need for robust mid-stage data.
Supernus’s latest failure leaves its future looking dim
Supernus needs something to fill the gap left by its faltering epilepsy drug Trokendi XR, but SPN-810 isn’t it.
A chance for the US regulator to show its teeth, at Amag’s expense
An advisory panel votes to pull Amag’s Makena from the market, but will the US regulator follow through?
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