Merck (MRK) Tops Q2 EPS by 3c, Updates FY Guidance

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Merck (MRK), Eisai Co. Granted FDA Breakthrough Therapy Designation for LENVIMA

July 31, 2018 5:46 AM EDT

Eisai Co., Ltd. and Merck & Co., Inc. Kenilworth, N.J., U.S.A. (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA (generic name: lenvatinib mesylate), the orally available kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s anti-PD-1 therapy KEYTRUDA (generic name: pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma... More

Merck (MRK) Reports Positive Opinion from EMA for KEYTRUDA (pembrolizumab) Combination with Pemetrexed & Platinum Chemotherapy

July 30, 2018 6:47 AM EDT

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA®, Mercks anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression. If approved, this would mark the first approval in Europe for an... More