Medical Tidbits,Spin-out company offering simple cancer testing raises investment capital

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With novel methods for detection and quantification of cancer from a blood sample, SAGA Diagnostics offers molecular tests to identify targetable gene mutations, monitor treatment response, and detect metastatic cancer earlier. The new spin-out company from Lund University is now launched with funding from LU Innovation System.

SAGA Diagnostics AB is a cancer diagnostics and disease monitoring company offering laboratory services to pharmaceutical industry, healthcare, and academia. The methods used by SAGA Diagnostics allow detection and analysis of circulating tumor DNA in the bloodstream and other “liquid biopsies” with exceptional sensitivity. A regular blood sample reveals not only the presence of cancer but also the quantity of tumor-specific gene mutations that can help guide therapy. This non-invasive approach has significant advantages compared to tissue biopsy, which is commonly used for companion diagnostic testing today. Moreover, the innovative tests can even be applied to tissue biopsies themselves to identify mutations that are below the limit of detection of conventional methods. read more

Medtronic CoreValve® System Maintains Survival Advantages Over Surgery in High Risk Aortic Stenosis Patients at Three Years

Medtronic plc (NYSE: MDT) today announced new data from the High Risk Study of the CoreValve U.S. Pivotal Trial that show superior clinical outcomes for transcatheter aortic valve replacement (TAVR) with the CoreValve® System compared to surgical aortic valve replacement (SAVR) out to three years. The positive data were published in the Journal of American College of Cardiology and simultaneously presented during a Featured Clinical Research session at 65th Annual Scientific Session & Expo of the American College of Cardiology (ACC.16).read more

Medtronic Announces Early Data and Completes Enrollment in CE Mark Cohort in Drug-Filled Stent Trial

Medtronic plc (NYSE: MDT) announced new clinical data today from one of the endpoints in the RevElution Trial for its novel, next-generation Drug-Filled Stent (DFS). These new data showed rapid vessel healing without inflammation in Optical Coherence Tomography (OCT) data of the complete one-month follow-up patient cohort. The results were unveiled at the 65th Annual Scientific Session of the American College of Cardiology (ACC) on the heels of completing enrollment in the 50-patient cohort of the RevElution Trial, which will be used to support CE (Conformité Européenne) Mark. read more

Semaglutide demonstrated superior improvements in glycaemic control vs placebo in adults with type 2 diabetes

– Findings from the first phase 3a clinical trial for semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue, demonstrated that treatment with semaglutide administered once-weekly, significantly improved glycaemic control compared to placebo in adults with type 2 diabetes previously managed with diet and exercise alone. Results from the SUSTAIN 1 trial were presented today at the Endocrine Society’s 98th Annual Meeting and Expo (ENDO 2016) in Boston, read more

Positive Efficacy And Tolerability Study Of Repatha® (evolocumab) In Statin-Intolerant Patients Published In “Journal of the American Medical Association

THOUSAND OAKS, Calif., April 3, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin IntolerantSubjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins. The study showed that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ezetimibe resulted in a significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) after 24 weeks. These data were presented today at a Late-Breaking Clinical Trial session at the American College of Cardiology’s 65th Annual Scientific Session (ACC.16) and simultaneously published in the Journal of the American Medical Association. read more

Stryker completes the acquisition of Synergetics USA, Inc.’s Neuro Portfolio

Kalamazoo, Michigan – April 1, 2016 – Stryker Corporation (NYSE:SYK) announced today the completion of its previously announced acquisition of Synergetics USA, Inc.’s Neuro Portfolio. The portfolio includes the Malis generator, Spetzler Malis disposable forceps, and Stryker’s existing Sonopet tips and RF generator.

As indicated in the February 10, 2016 press release, this transaction is expected to be neutral to Stryker’s 2016 adjusted net earnings per diluted share and accretive thereafter.

Student Pharmacists Honored for Fighting Prescription Drug Misuse

The American Pharmacists Association and the Cardinal Health Foundation announce winners of annual Generation Rx Award Student pharmacists from across the country and a clinical professor of pharmacy were honored recently for their outstanding efforts in preventing prescription medication misuse. The recognitions are part of Generation Rx, an ongoing education and outreach initiative created by theCardinal Health Foundation and The Ohio State University College of Pharmacy, in partnership with the American Pharmacists Association (APhA). read more

FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation

Hansa Medical AB (publ) today announced that the US Food and Drug Administration (FDA) has completed the safety review of the company’s Investigational New Drug application (IND) and has concluded that the proposed clinical investigation can proceed. This enables Hansa Medical to start a clinical study to primarily evaluate IdeS’ efficacy in making highly sensitized kidney patients with positive crossmatches eligible for transplantation by removing donor specific antibodies. The clinical trial is scheduled to begin soon. read more

Aesculap, Inc. to Participate at Association of periOperative Registered Nurses (AORN)Annual Surgical Conference and Expo

Aesculap, Inc., a leader in surgical instruments and rigid sterile containers is pleased to announce its participation at the AORN 2016 Annual Meeting on April 3-5, 2016 at Booth 353, Anaheim Convention Center, Anaheim, CA. The booth’s theme, “Confidence in our Products, Trust in our Expertise”, revolves around how Aesculap’s industry-leading products and services can help the customer drive efficiency in the OR, maximizing patient care.

Study where Diamyd® is administered directly into lymph nodes approved for expansion and inclusion of children from 12 years of age

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that DIAGNODE-1, an open-label clinical pilot study in which the diabetes vaccine Diamyd® is administered directly into lymph nodes, has been approved by the Swedish Medical Products Agency and the Ethics Review Board to be expanded from five to nine patients and to include children from 12 years of age.

As previously communicated, Professor Johnny Ludvigsson, principal investigator and sponsor of DIAGNODE-1, has submitted a first preliminary evaluation of data from the first four patients that have been monitored for six months in the study, as an abstract for the diabetes meeting “51st Annual Meeting of the Scandinavian Society for the Study of Diabetes (SSSD)” to be held in Reykjavik, Iceland , on April 21-22, 2016. This evaluation preliminarily shows that the treatment appears to be safe and tolerable. Even if the clinical progression in patients shows certain positive data in terms of the body’s own capacity to produce insulin, as well as better long-term blood sugar and lower insulin dose (please see press release issued on February 11, 2016), no conclusions are drawn regarding metabolic parameters in these few patients who still may be in the so called honeymoon-phase, often characterized by some regression of the disease. read more



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