Oncology

FDA Grants Priority Review to Merck’s sBLA for Second-Line Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma

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, as monotherapy for the treatment of adult …

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HPV Test Misses Twice as Many Women Who Develop Cervical Cancer as Cotesting, Quest Diagnostics Health Trends Study Finds

SECAUCUS, N.J., July 8, 2020 /PRNewswire/ — A Health Trends™ study from researchers at Quest Diagnostics (NYSE: DGX) and the University of Pittsburgh Medical Center (UPMC) provides new evidence that the HPV screening test is significantly less likely to detect cervical cancer and precancer than cotesting, a method which combines …

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Xencor and Atreca Partner to Discover, Develop and Commercialize Novel T Cell Engaging Bispecific Antibodies

MONROVIA, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, and Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on …

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Merck and Foghorn Collaborate to Discover and Develop Novel Oncology Therapeutics Against Transcription Factor Target

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foghorn® Therapeutics Inc., a company advancing an unprecedented class of therapeutics targeting the chromatin regulatory system in oncology, announced that it has entered into a strategic collaboration with Merck, known as MSD outside the United States and Canada. The collaboration will apply Foghorn’s proprietary Gene Traffic Control™ product platform …

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Merck and Eisai Receive CRL from the FDA for Keytruda Plus Lenvima Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s and Eisai’s applications seeking accelerated approval of KEYTRUDA, Merck’s anti-PD-1 therapy, …

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Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Chugai Pharmaceutical

CARLSBAD, Calif., July 8, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test …

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FDA Approves Inqovi Tablets, Oral Hypomethylating Agent Therapy for Intermediate and High-Risk MDS and CMML

PLEASANTON, Calif. & PRINCETON, N.J. & TOKYO–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI® (decitabine and cedazuridine) tablets. The three companies are all part of the Otsuka group of companies. INQOVI …

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FDA Places Clinical Hold on Cellectis MELANI-01 Study in Multiple Myeloma

NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) — Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the MELANI-01 trial has been placed on clinical hold by the U.S. Food and Drug Administration (FDA).   This clinical hold …

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Numab Therapeutics and Boehringer Ingelheim Partner to Develop Multi-specific Antibody Therapeutics for Cancer and Retinal Diseases

INGELHEIM, Germany & WAEDENSWIL, Switzerland–(BUSINESS WIRE)–Boehringer Ingelheim and Numab Therapeutics (Numab) today announced that they have entered into a research collaboration and worldwide licensing agreement. It will start with two projects aiming at novel therapies for difficult-to-treat lung and gastrointestinal (GI) cancers and patients with geographic atrophy (GA), a progressive, irreversible retinal …

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Immunomedics Announces Positive Results from Phase 3 Study of Trodelvy in Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., July 06, 2020 (GLOBE NEWSWIRE) —  Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the confirmatory Phase 3 ASCENT study of Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint of progression-free survival (PFS), as well as key …

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