Phase III
Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
The pharma said Thursday it is stopping a late-stage study of its blockbuster Keytruda plus the anti-TIGIT antibody vibostolimab and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, following a recommendation from an independent data monitoring committee.
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
With the late-stage win, Bayer announced Monday that it plans to talk to regulators about seeking approval in an indication that is central to its $3 billion-plus peak sales forecast.
Sangamo and Pfizer’s hemophilia A gene therapy candidate scored a Phase III victory last week. However, with the genomic medicine company soon to run out of cash, Sangamo’s short-term prospects look bleak but not unsalvageable, analysts say.
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance.
Merck’s clesrovimab lowered the risk of medically attended lower respiratory infections associated with RSV infection when used in infants, according to topline results announced Tuesday.
Innovent Biologics’ dual GLP-1/glucagon receptor agonist mazdutide is also being developed for chronic weight management. China’s regulator accepted Innovent’s drug application for this indication in February 2024.
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
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