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Oncology

Daiichi Sankyo and Sarah Cannon Research Institute Launch Strategic Collaboration to Develop Novel Cancer Therapies

NASHVILLE, Tenn. and TOKYO and MUNICH and BASKING RIDGE, N.J., Dec. 10, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute announced today a strategic oncology development collaboration. This partnership brings together Daiichi Sankyo’s expertise in developing novel cancer agents with Sarah Cannon’s leadership …

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FDA Grants Orphan Drug Designation to Merck KGaA’s Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

DARMSTADT, Germany, December 10, 2018 /PRNewswire/ — FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer First regulatory designation for M7824 following recent presentation of first clinical data in BTC BTC is a group of rare, aggressive gastrointestinal cancers associated with limited treatment options and …

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Bristol-Myers Squibb and Vedanta Collaborate to Evaluate Opdivo and VE800 in Advanced or Metastatic Cancers

NEW YORK & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and Vedanta Biosciences today announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo in combination with Vedanta Biosciences’ VE800, a rationally-defined human bacterial consortium, in patients with advanced or metastatic cancers. In a range of preclinical models of cancer, …

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Myriad Study Demonstrates EndoPredict Can Guide Chemotherapy Decision for Women with Early-Stage Breast Cancer

SALT LAKE CITY, Dec. 07, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that academic researchers from the Technical University of Munich (TUM) presented the first prospective outcomes data on EndoPredict® at the San Antonio Breast Cancer Symposium in San Antonio, Texas.  …

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AstraZeneca’s Phase 3 Head and Neck Cancer Trial with Imfinzi and Tremelimumab Fails to Meet Primary Endpoints

AstraZeneca and MedImmune, its global biologics research and development arm, today announced overall survival (OS) results for the Phase III EAGLE trial. EAGLE is a randomised, open-label, multi-centre trial evaluating Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) chemotherapy in patients with recurrent or metastatic head and …

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FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of a Specific Type of Metastatic Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with Avastin®(bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer …

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Novartis’ Investigational BYL719 plus Fulvestrant Improved PFS in Patients with PIK3CA Mutated HR+/HER2- Advanced Breast Cancer

Basel, December 6, 2018 – Novartis today announced additional analysis from the global Phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. In …

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Puma Biotechnology Presents Results from the HR-Positive Subgroup in Phase III Trial of Neratinib for HER2-Amplified, Early Stage Breast Cancer

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from the subgroup of patients with hormone receptor positive (HR-positive) breast cancer from the Company’s Phase III ExteNET Trial of neratinib for early stage HER2-Amplified breast cancer are being presented at the 2018 San Antonio Breast Cancer …

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AbbVie Halts Enrollment of Phase 3 Trial Evaluating Rova-T as Second-Line Therapy for Advanced Small-Cell Lung Cancer

NORTH CHICAGO, Ill., Dec. 5, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping …

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Genentech’s Kadcyla Cut the Risk of Disease Recurring by Half Compared to Herceptin in People With HER2-Positive Early Breast Cancer With Residual Disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50 percent …

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