Phase III
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.
Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.
This week, researchers published results from studies on treatments in lung disease, Alzheimer’s and various cancers. Here’s a look at that and more.
Eisai and Biogen announced positive data from a Phase III trial in Alzheimer’s of its drug lecanemab. Still, questions remain about the drug’s implications for the future of Alzheimer’s treatment.
The FDA has approved Regeneron and Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, making it the first drug approved for this indication.
The anti-amyloid approach to treating Alzheimer’s disease is seeing new life after Eisai and Biogen announced that lecanemab slowed progression of disease in a Phase III study.
The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
The announcement follows a subgroup analysis of the Phase III SOLO3 trial which showed patients treated with Lynparza saw a 33% greater risk of death than controls who received standard chemotherapy.
PRESS RELEASES