An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Amylyx Announces Pivotal Phase 3 GLP-1 Trial Design in Post-Bariatric Hypoglycemia On December 4, Amylyx announced the design of its pivotal Phase 3 LUCIDITY clinical trial for avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, for the treatment of post-bariatric...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Exelixis Provides Regulatory Update Related to Supplemental New Drug Application for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced Neuroendocrine Tumors Exelixis, Inc. on November 26 announced that the U.S. Food and Drug Administration (FDA) has notified the company...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * First Successful Clinical Trial with Anti-CD40L Antibody is Completed On October 29, a potentially major advancement for type 1 diabetes treatment was announced by the University of Miami Diabetes Research Institute (UM-DRI), in collaboration with the University of Chicago, regarding the...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Olfactive Biosolutions Granted Patent to Repurpose Food Molecules for Treatment of Hypertension On October 15, Olfactive Biosolutions, the leader in adapting food molecules to treat chronic diseases, was recently granted U.S. patent 12,102,611, Compositions And Methods For Treating Hypertension By Modulating...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Boehringer Receives U.S. FDA Breakthrough Therapy Designation and Initiates Two phase III Trials in MASH for Survodutide On October 8, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for survodutide (BI 456906), a...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Priority Review Granted for HER2-low or HER2-ultralow Metastatic Breast Cancer Treatment On October 1, AstraZeneca and Daiichi Sankyo announced that its supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * TEPEZZA Receives Approval in Japan to Treat TED On Sept. 24, Amgen announced that TEPEZZA® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) by Japan’s Ministry of Health, Labour and Welfare (MHLW)....
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Neuroendocrine Tumor Treatment Data Presented by Exelixis On September 16, Exelixis announced updated and final data from CABINET, a Phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort with...
