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Amgen's T-Vec to Receive FDA Decision Today
The vaccine, approved in Europe last week, is now awaiting approval in the United States.
Imlygic, or talimogene laherparepvec, a genetically modified herpes simplex type 1 virus developed by Amgen to be injected directly into tumors, where it replicates and forces tumor cell rupture, is waiting for FDA's decision. The NDA for this virus-based treatment has been submitted for melanoma.
An advisory panel for the FDA reviewed data from the phase 3 OPTiM trial and voted 22-1 in favor of approval back in April 2015. Now the FDA has to consider this panel's advice before it's decision later today.
Meanwhile, the European Medical Agency approved T-Vec for use in patients with unresectable melanoma that has not metastatized just last week.
Read more here.
High HSP60 Expression Signals Poor Prognosis, Aggressive Tumors in Ovarian Cancer
January 16th 2025High heat shock protein 60 (HSP60) expression in patients with ovarian cancer is associated with larger tumors, advanced stages, and worse survival outcomes, highlighting its potential as a prognostic biomarker.
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Real-World Evidence Confirms the Benefits of JAK Inhibitors in Patients With Rheumatoid Arthritis
January 16th 2025This systematic review of real-world observational studies demonstrated the effectiveness of Janus kinase (JAK) inhibitors in improving treatment adherence, persistence, clinical outcomes, and patient-reported outcomes among US patients with rheumatoid arthritis.
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