Medical Tidbits,Bionik Laboratories Advances Development of Lead Product ARKE GEN2 – Second Generation Robotic Lower-Body Exoskeleton

Prescription Drug Use Up

TORONTO, Sept. 15, 2015 /PRNewswire/ — Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders (“Bionik” or the “Company”), announced today that it has completed the design of its second generation robotic lower-body exoskeleton ARKE GEN2 and initiated production of the first rehabilitation units.

Novo Noridsk- New Xultophy® (IDegLira) phase 3b trial shows improvements in patient-reported outcomes versus insulin glargine

Stockholm, Sweden, 15 September 2015 – New findings from the DUAL(TM) V phase 3b clinical trial showed greater improvements in treatment-related satisfaction and patient-reported physical health in people treated with Xultophy® versus insulin glargine U100. The DUAL(TM) V trial evaluated the efficacy and safety of Xultophy® (IDegLira), a once-daily single-injection combination of Tresiba® (insulin degludec) and Victoza® (liraglutide) compared to further intensification with insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine U100.

EISAI TO PRESENT LATEST CLINICAL DATA ON LENVIMA® (LENVATINIB) AND HALAVEN® (ERIBULIN) AT EUROPEAN CANCER CONGRESS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts highlighting the latest clinical data on Lenvima® (generic name: lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases with a novel binding mode, “lenvatinib”) and Halaven® (generic name: eribulin mesylate; halichondrin class microtubule dynamics inhibitor, “eribulin”) will be presented during the European Cancer Congress (ECC) 2015, taking place in Vienna, Austria, from September 25 to 29.

NeuroMetrix Showcases Quell™ Wearable Pain Relief Technology at the Pri-Med East Annual Conference

BOSTON–(EON: Enhanced Online News)–NeuroMetrix, Inc. (NASDAQ:NURO) today announced that its Quell Wearable Pain Relief Technology will be exhibited at the Pri-Med East Annual Conference in Boston on September 18-20, 2015. The Pri-Med East Annual Conference curriculum is developed with the American College of Physicians and is an important source of education for primary care physicians and other healthcare professionals on a wide range of therapeutic topics and the latest treatments and therapies. Over 4000 persons are expected to attend. read more

Alnylam Reports Positive Initial Clinical Results for ALN-AS1, an Investigational RNAi Therapeutic Targeting Aminolevulinic Acid Synthase 1 (ALAS1) for the Treatment of Acute Hepatic Porphyrias

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today initial positive results from its ongoing Phase 1 clinical trial with ALN-AS1, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. The Phase 1 study is being performed in asymptomatic “high excreter” (ASHE) patients, who carry the genetic mutation of acute intermittent porphyria (AIP) and have elevated levels of aminolevulinic acid (ALA) and porphobilinogen (PBG), the toxic heme intermediates that mediate porphyria attacks read more

XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis

SANTA CLARA, Calif.–(BUSINESS WIRE)–XenoPort, Inc. (Nasdaq:XNPT) announced today positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis. XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score. XP23829 is a patented prodrug of monomethyl fumarate (MMF) in a novel oral formulation that was designed to potentially offer physicians and patients an effective, better tolerated and easier to use therapeutic option to currently available fumarate products. read more

Vanda Announces FDA Has Accepted for Review the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults  

WASHINGTON, Sept. 15, 2015 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Vanda’s filing of a supplemental New Drug Application (sNDA) for Fanapt® seeking approval as a maintenance treatment of schizophrenia in adults.

Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt®.

The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.

Harpoon Medical Enrolls Ten Patients in Early Feasibility Study with 100% Procedural Success

BALTIMORE, Sept. 15, 2015 /PRNewswire/ — Harpoon Medical, a medical device company focused on minimally-invasive, beating-heart, mitral valve repair, announced today that ten patients with severe degenerative mitral valve disease are now enrolled in its ongoing Early Feasibility Study at two clinical study sites in Europe.  The company will showcase the results of the Early Feasibility Study, including a 100 % procedural success rate, over 850 total implant days and echocardiographic data on the first two patients with trace MR during their six-month follow up visit, at the upcoming 2015 Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, CA on October 12, 2015.

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