Medical Tidbits,St. Jude Medical Receives FDA Approval for Industry’s First MultiPoint Pacing Technology

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the first-to-market MultiPoint Pacing technology featured on the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D), the Quadra Allure MP CRT-pacemaker (CRT-P) and two new quadripolar Quartet LV leads. MultiPoint Pacing technology enables a revolutionary approach and provides additional options, which may benefit CRT patients who are not responsive to other pacing alternatives. This approval is an important first step in the rollout of MultiPoint Pacing technology, and availability to U.S. physicians is expected in the first half of this year. read more

NeuroVive announces the CiPRICS study enrols 100 patients and reports favourable safety evaluation

NeuroVive Pharmaceutical AB (publ), the pioneers in mitochondrial medicine, announces that the independent safety committee has once again endorsed the continuation of the ongoing Phase II CiPRICS (Ciclosporin to Protect Renal function In Cardiac Surgery) study, using NeuroVive’s product CicloMulsion ® against acute kidney injury.

A second safety analysis has been completed by an independent safety committee following the enrolment of 100 patients in the CiPRICS study. The first safety assessment was conducted after the first 50 patients were enrolled. Both safety assessments are conducted in order to evaluate the treatment’s ongoing safety profile and allow continuation of patient enrolment in the study. On the basis of these satisfactory safety findings, the study will continue as planned with the goal to enrol 150 patients and complete the study in the second half of 2016. The CiPRICS study has enrolled 106 patients to date and is progressing as planned. read more

Agilis Biotherapeutics Sponsors Inaugural Angelman Syndrome Biomarker and Outcome Measures Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Agilis Biotherapeutics, LLC (Agilis), a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), announced today that the Company sponsored the first-ever Angelman Syndrome Biomarkers & Outcome Measures Consortium at the University of South Florida (USF), in Tampa, Florida. The one-day symposium, held on March 7, 2016 focused on the advent of reliable markers and clinical measures of Angelman syndrome (AS) for the development, evaluation and registration of innovative diagnostics and therapeutics. The meeting brought together leading researchers and clinicians from the Angelman syndrome community, AS families, representatives from the Angelman Syndrome Foundation (ASF) and the Foundation for Angelman Syndrome Therapeutics (FAST), and industry leaders from six companies. read more

Patheon Signs Flexible Manufacturing Agreement with Amgen

DURHAM, N.C.–(BUSINESS WIRE)–Patheon, the leading global provider of pharmaceutical development and manufacturing services, announced today that it has signed a manufacturing agreement with Amgen, one of the world’s leading biotechnology companies, headquartered in Thousand Oaks, CA. read more

Greater Survival Benefit Shown in Men with Early and Less Aggressive Metastatic Castration-Resistant Prostate Cancer Treated with ZYTIGA® Plus Prednisone

MUNICH–(BUSINESS WIRE)–Janssen-Cilag International NV today announced that data from a post-hoc analysis of the Phase 3 COU-AA-302 trial showed that ZYTIGA® (abiraterone acetate) plus prednisone provided an 11.8 months overall survival (OS) benefit (53.6 months vs 41.8 months; HR = 0.61 [95% CI, 0.43-0.87]; p = 0.0055), compared to an active control of placebo plus prednisone, in men with early and less aggressive chemotherapy-naïve metastatic castration-resistant prostate cancer  read more

ProNAi Therapeutics Granted Orphan Drug Designation for PNT2258 for the Treatment of Diffuse Large B-Cell Lymphoma  

PRNewswire/ – ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL). This is the second orphan drug designation obtained by ProNAi for PNT2258 for the treatment of DLBCL, following a similar grant by the European Commission in August 2015. read more

BioLife Solutions Provides Update on Customer Cell Therapy Clinical Trials and Development Programs

PRNewswire/ — BioLife Solutions, Inc. (NASDAQ: BLFS), a developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, today provided an update on several customer clinical trials and development programs using cellular therapies and cellular immunotherapies in human regenerative medicine applications.  Key developments include: read more

The European Association of Urology Upgrades UroLift® System Trial Data to its Highest Possible Classification – Level 1A – in its Guidelines

The UroLift system treatment for enlarged prostate was showcased today at the European Association of Urology international conference with the presentation of the four-year durability results of the multi-national L.I.F.T. randomised study and the two year results of the multi-national BPH6 randomised study.  These promising results were presented as the EAU Guidelines for male lower urinary tract symptoms (LUTS) upgraded the rating for UroLift data to the highest possible classification, Level 1A.  The EAU guidelines update comes as NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, announces key gains in European government healthcare system reimbursement in multiple markets. read more

Boston Scientific Receives U.S. FDA Approval For Blazer™ Open-Irrigated Catheter    

PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the Blazer™ Open-Irrigated (OI) radiofrequency ablation catheter. The Blazer OI catheter has been approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. The approval of the Blazer OI catheter marks the first time Boston Scientific will offer an open-irrigated catheter to the U.S. market. read more

Med Career News Medical Tidbits

Subscribe today for leading medical news and career advice from top medical recruiters!

Get Med Career News in your Inbox!

If you want to keep up with the latest news and career tips in the Medical Field subscribe today!

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.