Clinical Trial News
No Link Found Between Migraines, Parkinson's Disease
A study involving 39,000 women, including 7,300 with migraines, found no increased risk of Parkinson's disease among those with migraines. Published in the journal *Neurology*, the research suggests no association between migraines and Parkinson's, regardless of migraine frequency or aura presence.
The Journal of American Medical Association (JAMA) Publishes Elinzanetant Phase III Data
Elinzanetant, a dual NK-1 and 3 receptor antagonist, showed efficacy and safety in Phase III OASIS 1 and 2 studies for treating moderate to severe VMS in menopause, reducing VMS frequency and severity, and improving sleep disturbances and quality of life.
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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.
