Oncology

Caris Life Sciences and Debiopharm Partner to Develop Companion Diagnostic for Detection of Rare FGFR Fusions Using Novel Molecular Intelligence Transcriptome

IRVING, Texas, May 30, 2019 /PRNewswire/ — Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced that it has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic (CDx) test using its newly-launched Whole Transcriptome …

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Zymeworks’ ZW25 Granted Fast Track Designation from the FDA for Treatment of Patients with Gastroesophageal Adenocarcinoma

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW25, a novel Azymetric™ bispecific antibody, for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of …

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Data Published from Phase 3 Darzalex Shows Combination Therapy Increases PFS in Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

RARITAN, N.J., May 29, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the publication of data from the randomized, open-label Phase 3 MAIA (MMY3008) study that showed DARZALEX® (daratumumab) plus lenalidomide and dexamethasone (Rd) resulted in a significant increase in progression-free survival (PFS) in patients …

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Moffitt Cancer Center Partners with TuHURA Biopharma to Develop a New Generation of Targeted Immunotherapies

TAMPA, Fla. and SEATTLE, May 29, 2019 /PRNewswire/ — Moffitt Cancer Center announced today a licensing agreement with TuHURA Biopharma, Inc., a start-up biotechnology company in Seattle, to develop new immunotherapy treatments for cancer that will apply to a greater number of cancers and a larger patient population. This agreement …

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Bayer and Foundation Medicine Collaborate to Develop Next-Generation Sequencing-Based Companion Diagnostics in Oncology

CAMBRIDGE, Mass. and BERLIN, May 29, 2019 /PRNewswire/ — Bayer AG and Foundation Medicine, Inc. today announced a global collaboration for the development and commercialization of NGS-based companion diagnostics.  This agreement allows for collaboration across multiple oncology drug candidates and approved therapies developed by Bayer and covers Foundation Medicine’s full …

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Arvinas Receives Fast Track Designation for its Targeted Protein Degrader ARV-110 for Treatment of Metastatic Castration-Resistant Prostate Cancer

NEW HAVEN, Conn., May 29, 2019 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrades disease-causing proteins, today announced that its lead PROTAC® protein degrader, ARV-110, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for …

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Bayer Receives FDA Breakthrough Therapy Designation for Aliqopa for the Treatment of Marginal Zone Lymphoma

WHIPPANY, N.J., May 29, 2019 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form …

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FDA Approves Revlimid in Combination with Rituximab for Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved …

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Ziopharm Oncology Enters Exclusive License with NCI to Identify and Use T-Cell Receptors Targeting Neoantigens for Cancer with Sleeping Beauty Platform

BOSTON, May 28, 2019 (GLOBE NEWSWIRE) —  Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:ZIOP), a clinical stage immuno-oncology company developing next-generation cell and gene therapies, today announced an exclusive licensing agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health (NIH), for intellectual property …

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FDA Approves Novartis’ Piqray, the First and Only Treatment for Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer

Basel, May 24, 2019 – Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an …

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