GemPharmatech’s Weekly News Digest
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Accelerating Innovation Through Genetically Engineered Mouse Models (GEMMs) and Preclinical Services
1. CHMP Recommends Approval of Biogen ALS Drugs
February 23, 2024
Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of tofersen for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) due to superoxide dismutase 1 (SOD1) mutations. If successfully approved, tofersen will be the first gene-targeted therapy for ALS in Europe.
2. Potentially Best! Successful Phase II Study of Boehringer Ingelheim's GLP-1R/GCGR Agonist MASH
February 26, 2024
Boehringer Ingelheim announced that up to 83% of patients in a Phase II clinical trial for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) achieved statistically significant improvement after receiving survodutide (BI 456906) compared to placebo (18.2%).
3. Viking's Weight Loss Breakthrough - Can VK2735 Become a Dark Horse?
February 27, 2024
Viking announced positive results from the Phase II VENTURE study of VK2735, a dual GLP-1R/GIPR agonist, showing significant weight loss and favorable safety profile. The company plans to discuss next steps with the FDA for VK2735 development.
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4. Beigene's Tislelizumab Filed for Gastric Cancer Indication in the U.S.
February 27, 2024
Beigene has announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Tislelizumab in combination with fluoropyrimidine-containing and platinum-based chemotherapy for treating patients with locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (G/GEJ). The FDA is anticipated to decide on the BLA in December 2024, with an expected decision by the end of the second quarter of this year.
5. Nature's Epigenetic Editing Therapy for Lowering Cholesterol
February 28, 2024
Researchers at San Raffaele Scientific Research Hospital discovered long-lasting cholesterol control through epigenetic silencing without permanent genome editing. The study demonstrates the potential of epigenetic therapy in disease treatment.
6. AbbVie Introduces OSE-230 Monoclonal Antibody for Inflammatory Diseases
February 28, 2024
AbbVie enters a collaboration with OSE Immunotherapeutics for exclusive licensing of OSE-230, a new drug targeting severe chronic inflammatory diseases.
Reference: PHARMCUBE
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