Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer's disease therapy donanemab based on mid-stage clinical results, but says it remains on track
From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences tea
Suzhou-based CStone Pharmaceuticals' checkpoint inhibitor sugemalimab has proved effective in a trial as a first-line therapy for oesophageal cancer, setting up a regulatory filing in China
Before getting lost in the vast options a decentralised clinical trial (DCT) setup provides, sponsors considering a DCT model need to keep in mind that it is not a one-size-fits-all approac
The FDA's interactions with Biogen in the build-up to last year's controversial approval of Alzheimer's disease therapy Aduhelm have been described as "inappropriate" and "atypical" in a co
Switzerland's Idorsia has submitted a new drug application to the FDA for aprocitentan as a treatment for people whose blood pressure remains stubbornly high despite treatment and who are a
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.