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Bayer Acquires Full Rights to Loxo Oncology’s Vitrakvi and LOXO-195

WHIPPANY, N.J., Feb. 15, 2019 /PRNewswire/ — Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization, for Vitrakvi® (larotrectinib) and BAY 2731954 (LOXO-195). Both compounds are being developed globally for the treatment of adult …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal 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 and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase …

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Bayer’s Investigational Darolutamide Plus ADT Significantly Extends Metastasis-Free Survival in Phase 3 Study of Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., Feb. 14, 2019 /PRNewswire/ — Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS) with the investigational drug darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001).2 This translates …

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Opdivo Plus Yervoy Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced data evaluating Opdivo(nivolumab) in combination with Yervoy (ipilimumab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Results from an interim analysis of the Phase 2 CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy …

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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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