Clinical research
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease has been paused in the United States following a request from the FDA for additional data.
Salarius Pharmaceuticals voluntarily paused enrollment of its Phase I/II trial of seclidemstat for Ewing sarcoma and FET-rearranged sarcomas after a patient’s death.
GlaxoSmithKline (GSK) announced Tuesday morning it has struck a $70 million deal with Tempus in exchange for expanded access to Tempus’ AI-based patient data platform.
As part of its third-quarter report, Roche announced it has cut two Phase II programs, one for hepatitis B and the other for geographic atrophy, a form of eye disease.
An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer’s disease.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
Milestone Pharmaceuticals reported highly positive data from its Phase III RAPID trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) patients.
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD).
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
PRESS RELEASES