Each dose adjustment (titration) represents an opportunity for programming errors to occur; Sigma Spectrum Infusion System only pump to include built-in titration error prevention feature read more
ASCO Data Underscore Lilly’s Diverse Oncology Pipeline and Portfolio
PRNewswire/ — Several studies will underscore the strength of Eli Lilly and Company’s (NYSE: LLY) diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. Presentations include new data on abemaciclib, a CDK 4 and 6 inhibitor, as well as: ramucirumab, a VEGF Receptor 2 antagonist; galunisertib, a TGFβ small-molecule kinase inhibitor; and emibetuzumab, a MET antibody. read more
Acorda to Discontinue Development of PLUMIAZ for Treatment of Epilepsy Seizure Clusters
ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will discontinue development of PLUMIAZTM (diazepam) Nasal Spray, an investigational therapy being studied for the treatment of seizure clusters in people with epilepsy. Data from the ongoing clinical trials do not demonstrate its bioequivalence to Diastat® rectal gel, needed to re-file the New Drug Application (NDA) under section 505(b)(2). Specifically, the data demonstrated unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.
Boston Scientific Receives U.S. FDA Approval for Precision Montage™ MRI Spinal Cord Stimulator System
Full-Body MRI Access Expands Spinal Cord Stimulation Offering and Brings Customized Therapy to MoPRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System after receiving approval from the U.S. Food and Drug Administration. The Precision Montage System offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. Boston Scientific is introducing the system at the 8th World Congress of the World Institute of Pain in New York City on May 20-23, 2016.
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7839551-boston-scientific-precision-montage-mri/
More than 100 million Americans suffer from chronic pain, which can have a devastating impact on quality of life. Patients with pain sometimes experience a fluctuation in location, type and intensity of pain throughout the day or over time. The Precision Montage MRI SCS System allows patients to undergo a full-body MRI while benefiting from the pain relief of MultiWave™ Technology. MultiWave Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. In an analysis of registry information from 800 patients, it was determined that 72 percent used multiple waveforms to customize their therapy and optimize pain relief.
Ferring Pharmaceuticals and North Zealand University Hospital Announce eHealth Collaboration Aimed at Transforming IBD Patient Care
SAINT-PREX, Switzerland–(BUSINESS WIRE)–To mark World IBD Day 2016, Ferring Pharmaceuticals and North Zealand University Hospital in Copenhagen today announced a multi-year collaboration aimed at transforming the way in which patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) manage their condition and receive medical care. read more
Medtronic plc (NYSE: MDT) announced the U.S. launch of Spine Essentials(TM), a new platform of spinal implants and instruments designed to make the most common cervical spine fusion procedures more efficient and help hospital systems manage costs, while maintaining quality. The goal of Spine Essentials is to help surgeons and their staffs streamline the most common spinal fusions, by providing the exact tools in the right quantities needed to perform 1- and 2-level cervical spinal fusions, while reducing the costs and time required for instrument sterilization, case set up and inventory management.
Genetech FDA Approval
FDA gave accelerated approval to atezolizumab injection (Tecentriq, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody. May 18, 2016. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501878.htm
Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information. read more
ASCO Data Underscore Lilly’s Diverse Oncology Pipeline and Portfolio
PRNewswire/ — Several studies will underscore the strength of Eli Lilly and Company’s (NYSE: LLY) diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. Presentations include new data on abemaciclib, a CDK 4 and 6 inhibitor, as well as: ramucirumab, a VEGF Receptor 2 antagonist; galunisertib, a TGFβ small-molecule kinase inhibitor; and emibetuzumab, a MET antibody.
Other data to be presented at ASCO highlight Lilly’s ongoing immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in two trials that are evaluating ramucirumab and pemetrexed-plus-carboplatin, respectively, in combination with Merck’s pembrolizumab. read more
Lilly partners with Washington University School of Medicine and Meharry Medical College on unique summer research program
New Data Presented at EuroPCR 2016 Adds to the Growing Body of Clinical Evidence Supporting St. Jude Medical FFR Technology and LAA Closure
ST. PAUL, Minn. & PARIS–(EON: Enhanced Online News)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which include a look at how St. Jude Medical™ fractional flow reserve (FFR) technology impacts patient outcomes in Acute Coronary Syndrome (ACS) and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment – were presented during hotline sessions. read more
Researchers to Present Late-Breaking Data on ALXN1210 in Patients with PNH at EHA Annual Congress
NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that researchers will present late-breaking data from a Phase 1/2 dose-escalating study of ALXN1210, the Company’s highly innovative longer-acting C5 antibody, in patients with paroxysmal nocturnal hemoglobinuria (PNH). In another late-breaking poster, researchers will present additional results from a Phase 2 trial evaluating ALXN1007 in patients with acute graft-versus-host disease involving the lower gastrointestinal tract (GI-GVHD). read more
Comprehensive Collaboration Agreement between Osaka University and Chugai
Osaka University and Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) today announced the conclusion of a comprehensive collaboration agreement for advanced research in immunology between the Osaka University Immunology Frontier Research Center (IFReC) and Chugai. read more