Phase III
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.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.
One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.
AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.
Novartis outlined how its transformation to a pure-play innovative medicines company is nearly completed during a “Meet the Management” event in Switzerland.
Alaunos Therapeutics, Satsuma Pharmaceuticals, NeuroSense, Emyria and more reported updates in solid tumors, migraine, ALS and MDMA drug discovery.
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