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Oncology

FDA Approves Genentech’s Kadcyla for Adjuvant Treatment of HER2-Positive Early Breast Cancer with Residual Invasive Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant …

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FDA Grants Breakthrough Device Designation to Caris Life Sciences’ MI Transcriptome Companion Diagnostic Test

IRVING, Texas, May 3, 2019 /PRNewswire/ — Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s MI Transcriptome™ companion diagnostic (CDx) test. Designed to detect gene fusions in …

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Amgen and Syapse Enter Precision Medicine Collaboration in Oncology

THOUSAND OAKS, Calif. and SAN FRANCISCO, May 2, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN), a world leader in biotechnology, and Syapse, a company powering precision medicine insights through its global provider network, today announced a precision medicine collaboration in oncology. Under the terms of the agreement, Amgen and Syapse will develop …

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AMAL Therapeutics and Boehringer Ingelheim Partner to Evaluate ATP128 in Combination with BI754091 for Treatment of Certain Colorectal Cancer Patients

GENEVA, Switzerland , May 02, 2019 / B3C newswire / — AMAL Therapeutics (AMAL), a Swiss biotech developing novel, peptide-based therapeutic cancer vaccines, today announces that it has entered into a collaborative agreement with Boehringer Ingelheim. AMAL will conduct an international Phase Ib clinical study, referred to as KISIMA-01, to …

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FDA Approves Agios’ sNDA for Tibsovo as Monotherapy for Newly Diagnosed IDH1 Mutant AML Patients Not Eligible for Intensive Chemotherapy

CAMBRIDGE, Mass., May 02, 2019 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. Prescribing Information for …

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Transgene and AstraZeneca Enter Collaboration and Exclusive License Agreement for Innovative Invir.IO Based Armed Oncolytic Immunotherapies

STRASBOURG, France–(BUSINESS WIRE)–Regulatory News: Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases announces the signing of a collaborative research, option and exclusive license agreement with AstraZeneca to co-develop five armed oncolytic vaccinia virus candidates. Innovative oncolytic viruses resulting from this …

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Celgene and bluebird Announce Results from Ongoing Study of bb2121 anti-BCMA CAR T Cell Therapy in Patients with Multiple Myeloma Published in NEJM

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the New England Journal of Medicine (NEJM) has published interim results from CRB-401, the ongoing phase 1 study of bb2121, the companies’ lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate for patients …

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Myriad Announces that EndoPredict Predicts the Chemotherapy Benefit in Women with ER-Positive, HER2-Negative Breast Cancer

SALT LAKE CITY, April 30, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced an international team of cancer researchers has found that EndoPredict® test accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy.  Findings from the study …

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Sandoz Enters Agreement with EirGenix for Proposed Trastuzumab Biosimilar in Phase 3 Development

Holzkirchen, Germany, April 30, 2018 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar. This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) …

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Janssen Submits sNDA to the FDA for Expanded Approval of Erleada for Treatment of Metastatic Castration-Resistant Prostate Cancer

RARITAN, N.J., April 29, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The …

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