The biotech’s cardiology asset has failed an advanced study focused on exercise capacity in heart failure, having underwhelmed observers with past data, but hope remains that the LVEF subset could be a saving grace.
Cytokinetics, Inc.’s omecamtiv mecarbil has disappointed in yet another Phase III study of heart failure with reduced ejection fraction (HFrEF), but the firm is holding on to the hope that it could still benefit a specific patient subpopulation.
Omecamtiv missed the 276-patient placebo-controlled METEROIC-HF study’s primary endpoint of change from baseline in peak oxygen (pVO2) uptake at week...
Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.
As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.
Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.
