FLORENCE, Italy – The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini from Ryvu Therapeutics, and currently investigated in...
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BOLOGNA, Italy and HUNTINGDON VALLEY, Pa. – Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced today the launch of a new assay to meet the needs of pharma companies, CROs, clinicians and research scientists working on multiple myeloma (MM). This new CELLSEARCH® Circulating Multiple Myeloma Cells (CMMCs) Assay* captures...
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program...
RAHWAY, N.J. — Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors. Global Phase 3 studies have been initiated...
RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell...
DARMSTADT, Germany – Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced topline data from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant...
KENILWORTH, N.J. – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational...
RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in combination with standard of care rituximab and gemcitabine-oxaliplatin (R-GemOx) for the treatment of relapsed or refractory...
Cambridge, MA – Merck bumped up its position from shareholder to acquirer in a move to scoop up neurodegenerative disease biotech Caraway Therapeutics for up to $610 million, the pharma giant announced Tuesday. Merck previously invested in Caraway in 2018 through its MRL Ventures Fund, Merck will now acquire all outstanding...
Rahway, New Jersey – Merck’s blockbuster PD-1 inhibitor Keytruda (pembrolizumab) improved overall survival when used as an adjuvant treatment for renal cell carcinoma patients who are at intermediate-high or high risk of recurrence after nephrectomy, according to results of the Phase III KEYNOTE-564 trial posted Saturday. Compared with placebo, patients...