BioSpace News Archive

A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.

Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.

Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.

Wegovy’s highest dose significantly improved physical function and quality of life in obese patients with heart failure, according to results published Friday in The New England Journal of Medicine.

While an initial analysis showed improvements in progression-free survival and objective response rate, a second analysis saw no improvement in overall survival.

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd., a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B infection, announced the U.S. Food and Drug Administration has granted clearance for the Investigational New Drug application for a clinical trial on AHB-137.

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, is scheduled to participate in the following investor conferences in September.

XyloCor Therapeutics, Inc. presented results from the Phase 2 portion of its Phase 1/2 clinical trial of its lead gene therapy candidate XC001 for refractory angina at the European Society of Cardiology Congress 2023.

Merck, known as MSD outside of the United States and Canada, announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 inhibitor, being evaluated for the treatment of adults with hypercholesterolemia.

Merck, known as MSD outside of the United States and Canada, and Eisai provided an update on the Phase 3 LEAP-010 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1.