Medical Tidbits, Real-World Study Shows 72 Percent of Atrial Fibrillation Would Have Gone Undiagnosed in Stroke Patients if Cardiac Monitoring Had Been Limited to 30 Days

breaking medical device news

DUBLIN and VANCOUVER – APRIL 20, 2016 – Medtronic plc (NSYE: MDT) today announced one-year results from a real-world study of patients who had a cryptogenic stroke, or stroke of unknown cause. The study found that the Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) detected atrial fibrillation (AF) at a greater rate than previously reported in a randomized controlled clinical trial (the CRYSTAL AF Study, published in The New England Journal of Medicine in 2014). The results from the observational real-world study are being presented today at the 68th American Academy of Neurology Annual Meeting in Vancouver, Canada. read more

Targeted missiles against aggressive cancer cells

Targeted missiles that can enter cancer cells and deliver lethal cell toxins without harming surrounding healthy tissue. This has been a long-standing vision in cancer research, but it has proved difficult to accomplish. A research group at Lund University in Sweden has now taken some crucial steps in this direction. read more

Camurus AB: Distribution Agreement Signed with R-PHARM US for episil®

STOCKHOLM–(BUSINESS WIRE)–Regulatory News:Camurus (NASDAQ STO:CAMX) today announces that they have granted R-PHARM US (Princeton, NJ) the exclusive license and distribution rights for episil® oral liquid in the US.episil® oral liquid, is a unique and effective treatment for the pain of oral mucositis, a treatment-limiting side effect of cancer therapies, as well as other oral lesions. Financial terms under this agreement are not disclosed read more

Medtronic Announces Worldwide Voluntary Recall for Battery Pack In Covidien Oridion Labeled Capnostream™20 and Capnostream™20p Patient Monitors

DUBLIN – Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream™20 and Capnostream™20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The scope of this recall includes battery pack model numbers 016400 and 010520. These packs were manufactured by a contract manufacturer between April 2014 and February 2016. read more

SBP and GSK Create New Center for Translational Neuroscience

Academic-industry alliance seeks to find and validate new targets for drug development

Sanford Burnham Prebys Medical Discovery Institute (SBP), a leading fundamental and translational research institute, and GlaxoSmithKline (GSK), a global pharmaceutical company, have announced the creation of the SBP-GSK Center for Translational Neuroscience. The new Center, located on the SBP campus in La Jolla, will bring together experts from SBP and GSK to investigate factors that influence brain function and potentially reverse or slow down neurodegeneration, with the aim of identifying and validating new therapeutic targets. Under the three year agreement, GSK will provide funding to create and support a research laboratory. Staffed by SBP scientists, postdoctoral candidates and technicians working alongside neuroscientists from GSK, the Center will be designed to bolster research dedicated to translational neuroscience. read more

Baxter Receives Marketing Authorization in the United Kingdom and Denmark for NUMETA G13E Ready-To-Use IV Nutrition for Preterm Newborns

Only approved triple-chamber, commercially prepared IV product addressing critical nutritional needs of vulnerable neonatal patients

COMPTON, England, April 20, 2016 — To support the needs of vulnerable, preterm infants (less than 37 weeks gestation age) who are at high risk for malnutrition1, Baxter International Inc. (NYSE: BAX) today announced it has received Marketing Authorization from the Competent Authorities in the United Kingdom and Denmark for NUMETA G13E 300 mL, a parenteral (intravenous) nutrition (PN) product. These national approvals are the first of 20 European countries where Baxter is seeking authorization for NUMETA G13E in 2016. read more

Data Presented at AAN Highlight Impact of ZINBRYTA™ (Daclizumab HYP) on Cognitive Outcomes and the Reversibility of Its Targeted Mechanism of Action

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–New data presented today show that investigational therapy ZINBRYTATM (daclizumab HYP) provided improvements on cognitive outcome measures in people living with relapsing forms of multiple sclerosis (RMS). Additional data offer insight into ZINBRYTA’s targeted mechanism of action (MOA), demonstrating that it did not cause broad immune cell depletion and its effects on total lymphocyte counts were reversible within approximately 8 to 12 weeks upon treatment discontinuation. These results were presented by Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada. read more

Boston Scientific Announces CE Mark For MRI Labeling Of Emblem™ S-ICD Systems

European Approval Granted for Third-Generation System and All Previously Implanted, Second-Generation Systems

MARLBOROUGH, Mass., April 20, 2016 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems. read more

Novo Nordisk plans to invest more than 100 million euros in production plants in Chartres, France

Bagsværd, Denmark, 21 April 2016 ­- Novo Nordisk today announced that it plans to invest more than 100 million euros in production facilities at its site in Chartres, France. The expansions will help Novo Nordisk meet the increasing worldwide demand for its diabetes medicines.  The new facilities will be built on Novo Nordisk’s existing 31,000 m2 site in Chartres, which produces a range of the company’s insulin products as well as FlexPen®, the world’s most widely used insulin injection device. The products are exported to more than 40 countries all over the world. Novo Nordisk has invested 300 million euros in France over the past 15 years and today employs 1,100 employees at the site. The planned expansion is estimated to create around 250 new jobs once the facilities are fully operational within three to four years.“Novo Nordisk has been operating in France for more than 50 years,” says Lars Rebien Sørensen, president and CEO of Novo Nordisk. “Over the years we have built a very strong organisation in France, and our site in Chartres is today one of our most important strategic production sites. With the coming expansion we will further strengthen Chartres’ position in our global product supply organisation.”In addition to the 1,100 employees in Chartres, Novo Nordisk employs 300 people in its affiliate in Paris, which is responsible for the company’s medical, regulatory and commercial activities in France.

Interim results from DIAGNODE-1 indicate clear and desired re-balancing of the immune system after administration of Diamyd® directly into lymph nodes

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that Professor Johnny Ludvigsson will present preliminary immunological interim results from four patients in the pilot study DIAGNODE-1 at the diabetes meeting SSSD in Reykjavik 21-22 April. The interim results indicate that administration of a low dose of the diabetes vaccine Diamyd® in lymph glands clearly re-balances the immune system towards a desired so called Th2 response. As previously reported, the treatment appears to be safe and tolerable and the clinical progression seems positive. It is however too early to draw any conclusions in these few patients.  read more

WntResearch has received approval from the UK authorities for adjusted doses in the Phase 1b study with Foxy-5

WntResearch today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s proposed changes to the dose levels in the Phase 1b study with Foxy-5 – a potential new drug to inhibit the spreading of tumors. Further, the responsible ethics committee has provided clearance to begin enrollment of patients in the UK. A previously completed Phase 1 study indicates that Foxy-5 has biological activity already at lower dose levels than those originally planned for Phase 1b trial. The adjusted protocol now allows studies of doses in this lower range. read more

Vitamin K Deficiency Linked to Increased Risk of CVD in New Study

Arteriosclerosis, Thrombosis, and Vascular Biology , the journal for the American Heart Association, just published an 11-year study that draws a clear line between vitamin K deficiency and an increased risk of coronary heart disease.

To date, 19 Vitamin K–dependent proteins (VKDPs) have been described, with important roles in coagulation, platelet function, and vascular biology. Produced in an inactive form, all VKDPs obtain biological activity through the conversion of a glutamic acid residue into glutamate, a complex process requiring vitamin K. read more

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