Oncology

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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FDA Lifts Partial Clinical Hold on ADC Therapeutics’ Phase 2 Clinical Trial of Camidanlumab Tesirine in Hodgkin Lymphoma

LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal …

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MEI Pharma and Helsinn Group Discontinue Phase 3 Study of Pracinostat in AML After Interim Analysis

Lugano, Switzerland and San Diego, USA, July 2, 2020 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, and MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announce that an interim futility analysis of …

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Ipsen Joins Collaboration to Evaluate Cabozantinib Plus Atezolizumab in Metastatic NSCLC and Metastatic Castration-Resistant Prostate Cancer

Ipsen (Euronext: IPN; ADR: IPSEY), today announced it will join the Exelixis and Roche clinical collaboration and participate in the funding of the recently initiated CONTACT-01 and CONTACT-02 global Phase III pivotal trials. CONTACT-01 is evaluating the safety and efficacy of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients …

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FDA Grants Fast Track Designation to MetVital’s Anhydrous Enol-Oxaloacetate for Glioblastoma Multiforme

SAN DIEGO, July 1, 2020 /PRNewswire/ — MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, today announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that its …

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FDA Approves Bavencio as First-Line Maintenance Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, JUNE 30, 2020 – 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 approved the supplemental Biologics License Application (sBLA) for BAVENCIO® …

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