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Amgen and Allergan Announce Positive Top-Line Results from Comparative Clinical Study of ABP 798, Biosimilar Candidate to Rituxan

THOUSAND OAKS, Calif., Aug. 22, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint, an assessment of overall response rate (ORR) …

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FDA Grants Xtandi sNDA Priority Review for the Treatment of 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) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to add an indication …

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FDA Accepts and Grants Priority Review to BeiGene’s Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma

CAMBRIDGE, Mass. and BEIJING, China, Aug. 21, 2019 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s …

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FDA Approves Celgene’s Inrebic for Treatment of Patients with a Rare Bone Marrow Disorder

Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. Our approval today provides another option for patients,” said Richard Pazdur, M.D., …

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FDA Approves Genentech’s Rozlytrek for Patients with ROS1-Positive Metastatic NSCLC and NTRK Gene Fusion-Positive Solid Tumors

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) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to …

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FDA Grants Breakthrough Therapy Designation to AstraZeneca’s Calquence for Treatment of Chronic Lymphocytic Leukemia

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CALQUENCE® (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. José Baselga, Executive Vice President, Oncology R&D, …

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Phase 3 Trial of Lynparza Meets its Primary Endpoint as First-Line Maintenance Treatment in Advanced Ovarian Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the first-line maintenance setting, compared LYNPARZA added to standard-of-care bevacizumab versus bevacizumab alone in women …

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Deciphera’s Investigational Ripretinib Demonstrates Positive Results in Phase 3 Study in Patients with Advanced Gastrointestinal Stromal Tumors

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced positive top-line data from the INVICTUS pivotal Phase 3 clinical study of ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors …

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Boehringer Ingelheim and MD Anderson Form Unique Virtual Research and Development Center to Rapidly Advance New Cancer Therapies

Ingelheim, Germany, 12 August 2019 – Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center today announced a new multi-year partnership to conduct collaborative research to rapidly advance therapies for various types of cancers, including gastrointestinal and lung cancers. The establishment of a joint Virtual Research and Development …

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Onconova Therapeutics and Mission Bio Partner to Advance Precision Oncology Clinical Trials Employing Single-Cell Genomics

NEWTOWN, Pa. and SOUTH SAN FRANCISCO, Calif., Aug. 12, 2019 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), and Mission Bio, the pioneer in targeted single-cell DNA analysis and precision genomics, …

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