Oncology

Thermo Fisher Scientific Signs Agreement with Janssen to Co-Develop Companion Diagnostic for Cancer

CARLSBAD, Calif., March 12, 2020 /PRNewswire/ — Thermo Fisher Scientific announced today it has signed an agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to co-develop a companion diagnostic (CDx) in oncology. The CDx will support clinical trial enrollment globally. Under the agreement, …

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Preclinical Data Show Tumor Treating Fields Induces Immunogenic Cell Death Resulting in Enhanced Antitumor Efficacy When Combined with Anti-PD-1 Therapy

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) announced today that preclinical data on Tumor Treating Fields in combination with anti-PD-1 therapy were published in the peer-reviewed journal, Cancer Immunology, Immunotherapy. The published study suggests that Tumor Treating Fields therapy can induce anticancer immune response and provide the first evidence for the immunostimulatory effects of …

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Phase 3 Study of Cerdiranib and Lynparza Fails to Meet Primary Endpoint in Platinum-Resistant Ovarian Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced high-level results from the Phase 3 GY004 trial, led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI), that examined primarily the efficacy and safety of investigational medicine cediranib …

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FDA Grants Accelerated Approval for Opdivo Plus Yervoy for Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.1,2 Approval for this indication has been granted under …

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Roche Receives FDA Approval for CINtec PLUS Cytology Test to Aid Clinicians in Improving Cervical Cancer Prevention

Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of CINtec® PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas® 4800 HPV Test. This …

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Janssen Announces FDA Breakthrough Therapy Designation for JNJ-6372 for Treatment of Non-Small Cell Lung Cancer

RARITAN, N.J., March 10, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor …

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Phase 3 Study of Ninlaro Plus Lenalidomide and Dexamethasone Fails to Meet Primary Endpoint in Newly Diagnosed Multiple Myeloma Patients

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the results from the TOURMALINE-MM2 study designed to evaluate the addition of NINLARO™ (ixazomib) to lenalidomide and dexamethasone in newly diagnosed transplant ineligible multiple myeloma patients. The addition of ixazomib to lenalidomide and dexamethasone resulted in an …

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Study Finds Potential of Whole Breast Ultrasound Tomography to Improve Breast Cancer Risk Assessment

NOVI, Mich.–(BUSINESS WIRE)–Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, has announced that results of a study comparing the use of whole breast ultrasound tomography (UST) and mammography to assess breast cancer risk have been published in the Journal of Clinical Medicine. The study was conducted by researchers …

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FDA Accepts for Review Mylan and Biocon’s BLA for Proposed Biosimilar Bevacizumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, March 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway. The BLA seeks approval …

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Phase 3 Trial of Empliciti Plus Revlimid and Dexamethasone Fails to Meet Primary Endpoint Untreated Multiple Myeloma Patients

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb Company (NYSE: BMY) today announced topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. Both treatments were administered continuously until …

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