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Oncology

Janssen Announces Preliminary Results from Phase 2 Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects

SAN FRANCISCO, Feb. 14, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson will present today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) early results from the ongoing Phase 2 GALAHAD study evaluating niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with …

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Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the Phase 1b/2 KEYNOTE-365 umbrella trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with various agents for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). These …

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FDA Grants Priority Review for Bavencio Plus Inlyta for the Treatment of Advanced Renal Cell Carcinoma

Rockland, MA and New York, NY, February 11, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application …

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Opdivo Plus Low-Dose Yervoy Demonstrates Continued Survival Benefit at 30-Month Follow-up in Previously Untreated Advanced or Metastatic RCC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced new results from the Phase 3 CheckMate -214 study, showing that therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). With a minimum follow-up of 30 months, intermediate- and …

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Phase 3 Trial Shows Xtandi Significantly Improved Radiographic PFS in Men with Metastatic Hormone-Sensitive Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of …

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FDA Approves Janssen and Genmab’s Split-Dosing Regimen for Darzalex

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved a split dosing regimen for DARZALEX® (daratumumab).  The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of DARZALEX …

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AbbVie Partners with Teneobio to Develop BCMA Bispecific Antibody for Treatment of Multiple Myeloma

NORTH CHICAGO, Ill. and MENLO PARK, Calif., Feb. 11, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV),  Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. B-cell maturation antigen (BCMA) has emerged as an …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–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 a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the …

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TamRx Launches to Develop Pipeline of Immuno-Oncology Products for Treatment of Cancers

CLEVELAND–(BUSINESS WIRE)–BioMotiv, a drug development accelerator associated with The Harrington Project for Discovery & Development, and researchers from Rutgers, The State University of New Jersey, today announced the formation of a new biotech start-up, TamRx. The new company will focus on the development of a novel family of small molecule inhibitors designed …

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Newly Published Study Shows DecisionDx-Melanoma Prognostic Test Accurately Identified Risk for Patients with Melanoma of the Head and Neck

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, today announced the publication of a study highlighting the ability of the DecisionDx®-Melanoma test to accurately determine risk of metastasis in patients with melanoma of the head and neck. Results from …

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