Safety

News

FDA taps Cerner AI for Sentinel drug safety initiative

Oracle’s Cerner Enviza unit has been recruited by the FDA to develop artificial intelligence tools that will be used to glean information from patients’ electronic health

News

US eyes link between Pfizer bivalent COVID jab and stroke

Regulatory authorities in the US are investigating a possible link between the new Pfizer/BioNTech bivalent COVID-19 booster vaccine and strokes in people aged 65 or over, but still recomme

R&D

6 research and development life science predictions for 2023

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

News

Closeup of X-ray photography of human brain

Eisai questions link between lecanemab and patient death

With the FDA due to deliver a decision of Eisai and Biogen's new Alzheimer's disease candidate lecanemab tomorrow, the safety of the drug has been thrust into the spotlight by a case report

News

FDA slaps partial hold on Biogen, InnoCare MS drug

Biogen's efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China's InnoCare last year f

Patients