Oncology

FDA Grants Breakthrough Device Designation to Prescient Metabiomics’ LifeKit Prevent Test for Early Detection of Colon Polyps and Colon Cancer

CARLSBAD, Calif., Sept. 4, 2019 /PRNewswire/ — Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation …

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AbbVie and Idera Enter Immuno-Oncology Clinical Research Collaboration

EXTON, Pa., Sept. 04, 2019 (GLOBE NEWSWIRE) — Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) announced today that they have entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company.  The purpose of the collaboration is to conduct a clinical study evaluating whether combinations of an OX40 agonist …

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Boehringer Ingelheim Expands KRAS Cancer Program with Lupin’s Investigational MEK Inhibitor

Ingelheim, Germany and Mumbai, India – 4 September 2019 – Boehringer Ingelheim and Lupin Limited (Lupin) today announced a licensing, development and commercialization agreement for Lupin’s MEK inhibitor compound (LNP3794) as a potential targeted therapy for patients with difficult-to-treat cancers. The partnership aims to develop Lupin’s lead MEK inhibitor compound in …

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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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