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Oncology

Gritstone Oncology Announces FDA Fast Track Designation for GRANITE-001 for the Treatment of Colorectal Cancer

EMERYVILLE, Calif., Dec. 20, 2018 (GLOBE NEWSWIRE) — Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GRANITE-001 for the treatment of …

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Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 Trial of Xtandi in Metastatic Hormone-Sensitive Prostate Cancer

TOKYO & NEW YORK–(BUSINESS WIRE)–Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving …

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Gilead and Agenus Partner for Development of Immuno-Oncology Therapies

FOSTER CITY, Calif. & LEXINGTON, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Agenus Inc. (NASDAQ: AGEN) announced today the companies have entered into an immuno-oncology (I-O) partnership focused on the development and commercialization of up to five novel immuno-oncology therapies. Under the terms of the agreement, Agenus will receive $150 …

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FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel 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 approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the …

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AstraZeneca’s Lynparza Granted FDA Approval for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial …

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FDA Approves Myriad’s BRACAnalysis CDx as Companion Diagnostic for Lynparza in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer

SALT LAKE CITY, Dec. 19, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx® to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCAmutation …

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Amgen And Molecular Partners Announce Strategic Collaboration In Immuno-Oncology

THOUSAND OAKS, Calif. and ZURICH-SCHLIEREN, Switzerland, Dec. 18, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Molecular Partners AG(SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin®therapeutics, today announced a collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). MP0310 is a preclinical …

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Biocept and Prognos Partner to Apply Artificial Intelligence to Help Companies Optimize Commercialization of Biomarker-Targeted Therapies in Oncology

SAN DIEGO, Dec. 18, 2018 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, has entered into a Software License and Laboratory Data Supply Agreement with Prognos, Inc., an innovator in predicting disease …

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Lilly Announces Publication of Analyses Showing Benefit of Addition of Verzenio in Multiple Subgroups of Patients with Advanced Breast Cancer Identified as Having More Concerning Prognosis

INDIANAPOLIS, Dec. 18, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced npj Breast Cancer published results from exploratory subgroup analyses of the MONARCH 2 and MONARCH 3 trials reinforcing the clinical benefit of Verzenio® (abemaciclib) plus endocrine therapy in the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) …

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Bristol-Myers Squibb and Boston Medical Center Collaborate to Investigate Markers of Immuno-Oncology Response and Resistance

NEW YORK & BOSTON–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Center, a private, not-for-profit, academic medical center, today announced a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors. The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms …

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