FDA Approves Portrazza(TM) (necitumumab) for Specific Type of Lung Cancer
Portrazza, in combination with gemcitabine and cisplatin, is the first biologic approved for first-line treatment of people with metastatic squamous non-small cell lung cancer
INDIANAPOLIS, Nov. 24, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Portrazza™ (necitumumab injection for intravenous use, 800 mg/50 mL), in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for treatment of nonsquamous NSCLC.
Metastatic squamous NSCLC is a difficult-to-treat form of lung cancer with few treatment options.,,, The five-year survival rate for patients with metastatic disease is less than five percent. read more
Novogen Engages Contract Research Organisation to Conduct Cantrixil Phase 1 Clinical Trial
Novogen engages Novotech as CRO for upcoming Phase 1 clinical study
- Cantrixil Phase 1 clinical trial to be conducted in patients with refractory/recurrent peritoneal malignancies with malignant ascites, including ovarian cancer
US-Australian drug discovery company, Novogen Limited (ASX:NRT: NASDAQ: NVGN), announced today that it has engaged Novotech as the Contract Research Organisation (CRO) to conduct its Phase 1 clinical study for the drug candidate, Cantrixil, which will commence in 2016.
This first-in-human study will investigate the safety and feasibility of Cantrixil administered via the intraperitoneal route for patients with refractory /recurrent peritoneal malignancies with malignant ascites. read more
EDDA Technology Introduces the Newly FDA-Cleared IQQA®-Guide Intra-operative Precision 3D Navigation for Minimally Invasive and Robotic Surgical Treatment
PRINCETON, N.J., Nov. 25, 2015 /PRNewswire/ — EDDA Technology, a global leading provider in advanced imaging-guided precision treatment solutions, announced today that the company has received FDA clearance on IQQA®-Guide, a system that supports intra-operative precision 3D navigation for surgical procedures of thoracic, abdominal, and pelvic soft-organs read more
Teledyne DALSA Improves Accuracy of Diagnostics with New CMOS X-ray Detector for Mammography
WATERLOO, Ontario, Nov. 24, 2015 /PRNewswire/ — Teledyne DALSA, a Teledyne Technologies company and global leader in digital X-Ray image sensing technology, will introduce its CMOS X-Ray detector for mammography at the RSNA 2015 Technical Exhibition, November 29 to December 3, at McCormick Place in Chicago. The complete portfolio of dynamic detectors for diagnostic and interventional imaging will be on display in the South Hall, Booth 3135.
Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products
DARMSTADT, Germany & NEW YORK–(EON: Enhanced Online News)–Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by the European Commission (EC), expected in December. The COMP positive opinion is for the cancer immunotherapy avelumab, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 2,500 new cases of MCC diagnosed in the European Union (EU).3 There is currently no therapy approved specifically for the treatment of metastatic MCC.4 read more
Teva and Heptares Enter Agreement to Discover and Develop Novel, Small-Molecule CGRP Antagonists for Treatment of Migraine
JERUSALEM & LONDON–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Heptares Therapeutics (“Heptares”), a wholly owned subsidiary of Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce that they have entered into a licensing and drug-discovery agreement under which Teva will receive exclusive global rights to develop, manufacture and commercialize novel, small-molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine. . For more information, visit www.tevapharm.com.
Pfizer Receives European Approval to Expand Use of XALKORI® (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved a label update to expand use of XALKORI® (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that XALKORI significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.1 read more
FUJIFILM SonoSite Showcases Point of Care Ultrasound Solutions Designed to Support Clinician Needs at RSNA 2015
BOTHELL, Wash.–(BUSINESS WIRE)–(Booth #4165, South Building) – FUJIFILM SonoSite Inc., the disruptive specialist in designing cutting-edge ultrasound tools and world-leading education for access to point-of-care visualization, will showcase its complete range of point-of-care ultrasound systems, including the new iViz ultrasound solution at the 101st annual meeting of the Radiological Society of North America (RSNA) in Chicago, Ill. read more
XENIOS® AG receives CE mark for its i-cor® Synchronized Cardiac Assist System
HEILBRONN, Germany–(BUSINESS WIRE)–XENIOS® announced today that its i-cor® Synchronized Cardiac Assist System has received CE marking and can now be sold in Europe as the world’s first heartbeat-synchronized cardiac assist for cardiogenic shock and high-risk interventions. read more
Praxbind® (idarucizumab) approved in European Union for the specific reversal of Pradaxa® (dabigatran etexilate)
INGELHEIM, Germany–(EON: Enhanced Online News)–The European Commission has approved Praxbind® (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa® (dabigatran etexilate) in cases of emergency surgery / urgent procedures or in situations of life-threatening or uncontrolled bleeding.1 Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European Union.1