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Oncology

Puma’s Nerlynx Granted Orphan Drug Designation from the FDA for Treatment of Breast Cancer Patients with Brain Metastases

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases. “Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients …

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FDA Grants Breakthrough Device Designation to Laboratory for Advanced Medicine’s Liquid Biopsy Liver Cancer Detection Test

IRVINE, Calif., Sept. 3, 2019 /PRNewswire/ — Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company with innovative technologies for the early diagnosis of cancer, today announced that its Liver Cancer detection test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The liquid …

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FDA Grants Fast Track Designation to Forty Seven’s Magrolimab for Treatment of Myelodysplastic Syndrome and Acute Myeloid Leukemia

MENLO PARK, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) — Forty Seven, Inc., a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to magrolimab (formerly known as 5F9) for …

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RIKEN and Astellas Enter into Worldwide Exclusive Licensing Agreement for Artificial Adjuvant Vector Cell Technology in Oncology

Saitama and Tokyo, September 2, 2019 – RIKEN (President: Hiroshi Matsumoto, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that they have entered into a worldwide licensing agreement for the research, development and commercialization of cell therapy formulations applying RIKEN’s artificial adjuvant vector …

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After Phase 3 Failure, AbbVie Discontinues Rova-T Research and Development Program

NORTH CHICAGO, Ill., Aug. 29, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research based global biopharmaceutical company, today announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with …

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Immunicum Announces Topline Results from its Phase 2 Study in Patients with Metastatic Renal Cell Carcinoma

Immunicum AB (publ) announced today the topline results from the global, exploratory, Phase II Metastatic Renal Cell Carcinoma (MERECA) clinical trial. The study’s objective was to evaluate the therapeutic impact of combining ilixadencel with Sutent® (sunitinib). The most important outcome was achieving 5 complete responses, defined as eradication of the …

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Celgene and Immatics Enter up to $1.6 Billion Cancer T-Cell Collaboration

Houston, Texas and Tuebingen, Germany, August 28, 2019 – Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, today announced that Immatics and Celgene Corporation have entered into a strategic collaboration and option agreement to develop novel adoptive cell therapies targeting multiple …

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Adaptimmune and Noile-Immune Partner to Develop Next Generation Treatments for Cancer with T-Cell Technology

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 27, 2019 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Noile-Immune Biotech, Inc., Tokyo, Japan, a biotechnology company focusing on the development of innovative cancer immunotherapies, today announced that they will co-develop next-generation SPEAR T-cell products, …

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Kintai Therapeutics Announces Collaborations with Leading Academic Centers to Identify Novel Targets for Cancer

CAMBRIDGE, Mass., Aug. 27, 2019 (GLOBE NEWSWIRE) — Kintai Therapeutics, a Flagship Pioneering company, today announced that it has established new collaborations with leading academic institutions to identify novel molecules that play a fundamental role in microbe to human communication in different forms of cancer. The company has started to …

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GSK Announces Positive Results from the Pivotal DREAMM-2 Study for Multiple Myeloma

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomized study of two doses of belantamab mafodotin (GSK2857916). The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The …

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