Phase III
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.
Shares of Spero Therapeutics soared in premarket trading following GlaxoSmithKline’s announcement that it will license the company’s late-stage antibiotic asset, tebipenem HBr.
New data from Novo Nordisk’s Phase IIIa ONWARD 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes.
After enduring nine months of clinical holds, Merck announced that it is restarting the Phase III clinical program for islatravir, its candidate for people with HIV-1 infection.
The past week saw promising developments in candidate therapies for cancer, congenital hyperinsulinism, chronic cough and COVID-19 vaccines.
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