Clinical Trial News
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
Moderna's updated COVID-19 vaccine targeting KP.2 variant of SARS-CoV-2 has been approved by the U.S. FDA for individuals 12 years and above, with EUA granted for those 6 months through 11 years. The vaccine aims to prevent COVID-19 and is expected to be available soon.
Bayer Initiates Phase II Study of Soluble Guanylate Cyclase Activator (BAY3283142) in Patients with Chronic Kidney Disease
Bayer starts Phase II ALPINE-1 study of BAY3283142, an sGC activator for chronic kidney disease, aiming to provide a new treatment option for cardiovascular diseases.
Molecule One-Pager: KT-474 (SAR444656)
Explains Phase II drug metabolism, summarizes common enzyme-mediated bioconjugation reactions, and discusses examples of Phase II transformations and their impact on drug pharmacology.
FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancer
FDA approves Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for first-line treatment of EGFR-mutated advanced NSCLC, marking a significant development for patients with unmet needs.
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Tirzepatide Reduced the Risk of Developing Type 2 Diabetes by 94% in Adults with Pre-Diabetes and Obesity or Overweight
Tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight, and resulted in sustained weight loss over a three-year treatment period.
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Regeneron Provides Update on Biologics License Application for Linvoseltamab
FDA issued a Complete Response Letter for Regeneron's linvoseltamab BLA in R/R MM; issue relates to a third-party fill/finish manufacturer. Regeneron working with manufacturer and FDA to resolve and bring linvoseltamab to R/R MM patients. EMA review ongoing. Linvoseltamab is investigational, not yet approved.
GSK Receives US FDA Breakthrough Therapy Designation for B7-H3-Targeted Antibody-Drug Conjugate GSK5764227 in Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
GSK receives US FDA Breakthrough Therapy Designation for B7-H3-targeted ADC GSK5764227 in relapsed or refractory ES-SCLC.
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U.S. FDA Grants Tentative Approval of Yutrepia (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
The U.S. FDA has granted tentative approval to Yutrepia (treprostinil) inhalation powder for treating PAH and PH-ILD, pending the expiration of a competing product's exclusivity. Liquidia plans to challenge the FDA's grant of exclusivity to United Therapeutics for Tyvaso DPI to expedite Yutrepia's full approval.
Arthrosi Therapeutics Receives FDA Fast Track Designation for AR882 in Tophaceous Gout
Arthrosi Therapeutics receives FDA Fast Track Designation for AR882 in treating tophaceous gout, a serious condition affecting 2 million gout patients in the U.S. AR882, a next-generation URAT1 inhibitor, aims to address this unmet medical need.
Enrollment Completed for Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease
Vimgreen Pharmaceuticals completed enrollment for its Phase 2 trial of VG081821AC, an A2A receptor antagonist for early-to-mid stage Parkinson's disease, with 150 participants. The trial aims to assess VG081821's safety and efficacy as monotherapy, potentially offering a non-dopaminergic treatment option to avoid motor complications associated with long-term L-Dopa use.
