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Nanodiamonds show promise for aiding recovery from root canal
People who undergo root canals may soon have a tiny but powerful ally that could prevent infection after treatment.Researchers at theUCLA School of Dentistry and theUCLA Henry Samueli School of Engineering and Applied Science found in a clinical trial that nanodiamonds protected disinfected root canals after the nerve and pulp were removed, thereby improving the likelihood of a full recovery. The findings are a milestone for the use of nanodiamonds in humans.Nanodiamonds are tiny particles made of carbon and are so small that millions of them could fit on the head of a pin. They resemble soccer balls but have facets like a...
Source: UCLA Newsroom: Health Sciences - October 23, 2017 Category: Universities & Medical Training Source Type: news

OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. Get the full story at our sister site, Drug Delivery Business News. The post OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Diabetes Food & Drug Administration (FDA) Hospital Care Patient Monitoring Regulatory/Compliance OptiScan Source Type: news

Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. Get the full story at our sister site, Drug Delivery Business News. The post Cerveau inks licensing deal with AbbVie for tau imaging agent appeared fir...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Imaging Pharmaceuticals Wall Street Beat AbbVie Cerveau Technologies Source Type: news

NYU Dentistry receives $2.8 million as part of multi-center study to stop progression of cavities
NIH-funded study to test cavity-fighting liquid at three clinical sitesNew York UniversityThe National Institute of Dental& Craniofacial Research, part of the National Institutes of Health, has awarded a grant that will provide funding to New York University College of Dentistry (NYU Dentistry) and its collaborators to test the effectiveness of silver diamine fluoride in stopping the progression of cavities in young children.The grant provides $9.8 million over four years, $2.8 million of which will come to NYU Dentistry, to fund a Phase III randomized controlled trial at three clinical sites: University of Michigan, U...
Source: Dental Technology Blog - October 23, 2017 Category: Dentistry Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints ...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Surmodics goes head-to-head with Medtronic ’ s drug-coated balloon in pivotal trial
Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat Medtronic SurModics Inc. Source Type: news

Simulation Modeling and Systems Science to Address Health Disparities (R01-Clinical Trial Not Allowed)
The purpose of this Funding Opportunity Announcement (FOA) is to support investigative and collaborative research focused on developing and evaluating simulation modeling and systems science to understand and address minority health and health disparities. (Source: HSR Information Central)
Source: HSR Information Central - October 23, 2017 Category: International Medicine & Public Health Source Type: news

Typical and Atypical Patterns of Language and Literacy in Dual Language Learners (R01-Clinical Trial Optional)
The purpose of this FOA is to support investigator-initiated R01 applications that will inform our understanding of the typical and atypical patterns of language and literacy development of dual language learners (DLLs) in the United States. (Source: HSR Information Central)
Source: HSR Information Central - October 23, 2017 Category: International Medicine & Public Health Source Type: news

Typical and Atypical Patterns of Language and Literacy in Dual Language Learners (R21-Clinical Trial Optional)
Funding to support investigator-initiated R21 applications that will inform our understanding of the typical and atypical patterns of language and literacy development of dual language learners (DLLs) in the United States. (Source: HSR Information Central)
Source: HSR Information Central - October 23, 2017 Category: International Medicine & Public Health Source Type: news

NCI Awards A & G Pharmaceutical $2 million for Clinical Trial in...
A&G Pharmaceutical (A&G) was awarded a Phase 2 SBIR after successfully completing pre-clinical testing of a therapeutic monoclonal antibody specific for the autocrine growth and survival...(PRWeb October 23, 2017)Read the full story at http://www.prweb.com/releases/2017/10/prweb14823955.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 23, 2017 Category: Pharmaceuticals Source Type: news

RenovaCare raises $2m on path to improve burn, wound care with its “ SkinGun ”
RenovaCare said this week it raised $2.3 million in a new direct offering to support its “SkinGun,” which CEO Thomas Bold thinks could be a significant boon to the burn and wound care industry. This summer, CEO Bold spoke to MassDevice.com about the company’s SkinGun and CellMist technologies and what he thinks they can do to improve outcomes and reduce pain compared to current wound care treatments. The company’s SkinGun uses a sample of stem cells collected from a patient’s healthy skin, which are isolated and placed into a water-based solution in a syringe, which is then attached to the dev...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Wound Care RenovaCare Source Type: news

7 medtech stories we missed this week: Oct. 20, 2017
[Image from unsplash.com]From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime Embolic Protection System (EPS). The MGuard Prime EPS treats acute coronary syndromes like acute myocardial infarctions. 2. Medacta launches MiniMed hip stem Medacta has launched its MiniMAX Hip System in the U.S., according to an Oct. 12 press relea...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Implants Orthopedics Patient Monitoring Regulatory/Compliance Surgical Ultrasound Esaote Hill-Rom Holdings Inc. Honeywell InspireMD Medacta Source Type: news

YAG Laser Treats Symptomatic Vitreous Floaters YAG Laser Treats Symptomatic Vitreous Floaters
YAG laser treatment of symptomatic Weiss ring floaters was superior to sham treatment in a small clinical trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 20, 2017 Category: Consumer Health News Tags: Ophthalmology News Source Type: news

YAG Laser Treats Weiss Ring Floaters YAG Laser Treats Weiss Ring Floaters
YAG laser treatment of symptomatic Weiss ring floaters was superior to sham treatment in a small clinical trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 20, 2017 Category: Consumer Health News Tags: Ophthalmology News Source Type: news

Cover Story: Clinical trials deliver a real dose of hope to cancer patients
Far from being a last resort or a Hail Mary for cancer patients, clinical trials often help test subjects and provide vital foundations for future treatments, practitioners and researchers say. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 20, 2017 Category: American Health Authors: Elise Reuter Source Type: news

Cover Story: A report on clinical trials
This week's special report examines clinical trials targeting cancer, and the accompanying infographic takes a look at clinical trials in Kansas and Missouri, plus a breakdown of the phases of a trial. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 20, 2017 Category: Biotechnology Source Type: news

Cover Story: Clinical trials deliver a real dose of hope to cancer patients
Far from being a last resort or a Hail Mary for cancer patients, clinical trials often help test subjects and provide vital foundations for future treatments, practitioners and researchers say. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 20, 2017 Category: Biotechnology Authors: Elise Reuter Source Type: news

Tufts wins award to participate in new national emergency medicine clinical trials network
(Tufts Clinical and Translational Science Institute) Tufts Medical Center (Tufts MC) joins an elite group of institutions selected to lead national clinical trials in the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Network, a new initiative of the National Institutes of Health (NIH) to advance critical emergency medicine research. The SIREN Network is five-year NIH cooperative award that brings together 15 'Hub' institutions and their local 'spoke' sites to provide a national infrastructure for conducting large multi-site clinical trials. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 20, 2017 Category: International Medicine & Public Health Source Type: news

Weight Loss in Italy?
One of the women I work with wanted to know about the new diet drug called Belviq. The FDA is always approving a new “miracle” weight-loss pill, only to recall it a few years later. To date, at least 34 diet drugs have been taken off the market. Diet pills cause all kinds of problems — heart attack, stroke and psychiatric disorders. And Belviq isn’t any different. Some of its side effects include suicidal thoughts, a racing heartbeat, hallucinations and more… The European Union banned Belviq. The reason? It causes cancer in animals.  And here’s the real irony… Clinical tri...
Source: Al Sears, MD Natural Remedies - October 19, 2017 Category: Complementary Medicine Authors: Cathy Card Tags: Anti-Aging Source Type: news

Prostate problem? Take 2 nuts
By age 60, you have a 50/50 chance of having a clinically enlarged prostate. And it only gets worse every year. When your prostate isn’t functioning properly, it’s hard to enjoy life. Traditional doctors give you two choices. Go under the knife or you take Big Pharma’s drugs. Either way, you have a good chance of ending up with your manhood on the line… If you have surgery, there’s a big risk you’ll be saying goodbye to your sex life for good. The rate of impotence is a shocking 50 to 60% after prostate surgery.1 Big Pharma’s meds to shrink your prostate are no better. These sy...
Source: Al Sears, MD Natural Remedies - October 19, 2017 Category: Complementary Medicine Authors: Cathy Card Tags: Anti-Aging Source Type: news

This company helps cell therapies travel around the world
With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient’s own cells to genetically engineer a cancer-killing cellular therapy that is then delivered back to the patient. And one 55-person company is responsible for getting those products safely from the manufacturer to the patient. Get the full story at our sister site, Drug Delivery Business News. The post This company helps cell therapies travel around the world appeared first on...
Source: Mass Device - October 19, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Pharmaceuticals Wall Street Beat cryoport Gilead Sciences kitepharma Novartis Source Type: news

Pixium Vision wins French approval for Prima sub-retinal implant study
Pixium Vision (EPA:PIX) said today it won approval from France’s regulatory agency to launch a feasibility clinical study of its next-gen Prima sub-retinal implant in patients with advanced dry age-related macular degeneration. The Prima system is a next-gen wireless implant with a micro photovoltaic chip designed to be implanted under the retina to convert pulsed near-infra-red invisible light received from external glasses with an integrated mini-camera into electrical signals transmitted to the brain through the optic nerve, the company said. The system is designed to treat retinal dystrophies with a foc...
Source: Mass Device - October 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Pixium Vision Source Type: news

Dana-Farber/Brigham and Women's researchers laud FDA approval of CAR T-cell therapy
(Dana-Farber Cancer Institute) Following a successful clinical trial involving Dana-Farber Cancer Institute and Brigham and Women's Hospital, the first chimeric antigen receptor (CAR) T-cell therapy for adult cancers was approved by the Food and Drug Administration (FDA) today. Dana-Farber/Brigham and Women's Cancer Center, the only facility in the northeast to be part of the clinical trial, is one of a few locations certified to offer this new therapy nationwide. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 19, 2017 Category: International Medicine & Public Health Source Type: news

FDA-approved clinical trial tests stem cells to heal wounds
(Sanford Health/Sanford Research) Sanford Health is launching its second adipose-derived stem cell clinical trial -- this one to focus on non-healing leg wounds. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 19, 2017 Category: International Medicine & Public Health Source Type: news

FDA committee backs Novo Nordisk ’ s once-weekly type II diabetes drug
An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug. Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece. Get the full story at our sister site, Drug Delivery Business News. The post FDA committee backs Novo Nordisk’s once-weekly type II diabetes drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news

Effect of flowable composites on the clinical performance of non-carious cervical lesions: A systematic review and meta-analysis
ConclusionsWe have moderate confidence that the resin composite viscosity does not influence the retention rates at 3 years. Similar marginal discoloration and better marginal adaptation was observed for flowable composites but the quality of evidence is doubtful. (PROSPERO CRD42015019560). (Source: Dental Technology Blog)
Source: Dental Technology Blog - October 18, 2017 Category: Dentistry Source Type: news

Tiny Ignyta's Lung Cancer Drug Bested Pfizer's. Probably. Will We Ever Know For Sure?
Results of a 32-patient study of a drug made by Ignyta Pharmaceuticals, a San Diego-based drugmaker, are a best case scenario for the company. The drug shrank tumors in 79% of patients and kept workingabout 10 months longer than the current drug, Pfizer ’s Xalkori, did in earlier clinical trials. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - October 18, 2017 Category: Pharmaceuticals Authors: Matthew Herper, Forbes Staff Tags: NASDAQ:RXDX NYSE:PFE Source Type: news

FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product. The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both its guidance of between $70 and $80 million and Wall Street consensus of $80.1 million. Revenue for MiMedx grew 31% compared to sales from the 3rd quarter of the previous year, according to an SEC filing. “Our third quarter revenue performance was very strong, and we a...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials MiMedx Group Inc. Source Type: news

Second Sight wins go-ahead for German Argus II study in better-sighted RP patients
This study has the potential to change the management of patients with RP and, if successful, greatly expand the patient population who can benefit from this treatment, and for whom the Argus II could be a solution,” Dr. Walter of Germany’s Universitätsklinikum Aachen said in a prepared statement. In July, Second Sight said its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia. See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif. The post...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Regulatory/Compliance Second Sight Source Type: news

Researchers combine a smart phone, insulin pump and CGM in diabetes study
In a study published this week in Diabetes Care, researchers combined an insulin pump, a continuous glucose monitoring receiver and a smart phone with cloud-based algorithms to automatically monitor and adjust a patient’s glucose levels. The team pointed towards a number of systems that are designed to function as an artificial pancreas, but still require that users input their carbohydrate estimates when they need insulin after meals. Get the full story at our sister site, Drug Delivery Business News. The post Researchers combine a smart phone, insulin pump and CGM in diabetes study appeared first on MassDevice...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pharmaceuticals Harvard University Source Type: news

TCT 2017: Rich in Clinical Trials, Star Power TCT 2017: Rich in Clinical Trials, Star Power
Oscar-winner Tom Hanks headlines a conference that will feature clinical trials looking at management of left main disease, cardiogenic shock, and bioabsorbable scaffolds.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 17, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Medical News Today: Type 2 diabetes: Blood sugar pill shows promise
In a 26-week phase II clinical trial for type 2 diabetes patients, glycemic control using semaglutide in pill form was better than using a placebo. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - October 17, 2017 Category: Consumer Health News Tags: Diabetes Source Type: news

Diabetes Pill Might Replace Injection to Control Blood Sugar
TUESDAY, Oct. 17, 2017 -- An injectable class of diabetes medication -- called glucagon-like peptide-1 or GLP-1 -- might one day be available in pill form, research suggests. Based on the results of a global phase 2 clinical trial, the study... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 17, 2017 Category: General Medicine Source Type: news

m-Health Data Scientist
Location: Lausanne, Switzerland Job Type: Full-Time Employer: Nestlé Research Center (NRC) The m-Health Data Scientist will be part of a Biostatistics and Data Management Group within the Clinical Development Unit and will contribute to establishing a digital clinical research platform for capturing, managing and analyzing data from clinical trials and other external sources (e.g. mobile health devices, real-world data) to answer specific research questions, build real-world evidence and generate new business and scientific insights. (Source: eHealth News EU)
Source: eHealth News EU - October 17, 2017 Category: Information Technology Tags: Featured Jobs Source Type: news

UB spinoff company For-Robin moves one step closer to human clinical trials
(University at Buffalo) Scientists from For-Robin Inc., a University at Buffalo biotechnology spinoff, have published new scientific results showing that the company's cancer-fighting antibody can target, penetrate and kill human tumor cells effectively. The findings bring the company closer to human clinical trials. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 17, 2017 Category: Cancer & Oncology Source Type: news

Three of the most deadly cancers get critical funding for research
(Alliance for Cancer Gene Therapy) Three of the most deadly cancers -- glioblastoma, sarcoma and ovarian -- get critical funding for clinical trials from Alliance for Cancer Gene Therapy. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 17, 2017 Category: Cancer & Oncology Source Type: news

HIV infection, even with antiretroviral therapy, appears to damage a growing child's brain
(Frontiers) One of the largest and best-documented trials of children receiving early antiretroviral therapy -- the CHER clinical trial in South Africa -- finds ongoing white matter damage in HIV-positive children at the age of 7 years. The study aims to contribute to a better understanding of brain development in HIV-infected and exposed children, as well as the impact of long-term antiretroviral treatment. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - October 17, 2017 Category: Biology Source Type: news

'Magic mushrooms' may help 'reset' depressive brains, study claims
Conclusion For people with depression who are not helped by conventional treatment such as antidepressants and talking therapies, studies such as this one may offer a glimmer of hope. This and previous studies on psilocybin suggest it may one day become a treatment option for people with a range of psychiatric conditions. It's important to note that this is experimental, early-stage research. The study lacked a control group, so it's hard to know whether the improvement in mood, or the changes seen on MRI scans, can be attributed to the drug. The study is very small and we should bear in mind that half of those taking part...
Source: NHS News Feed - October 16, 2017 Category: Consumer Health News Tags: Mental health Neurology Source Type: news

When Is Digital Technology Not a Medical Device in the US?
Conclusion Whether you are an incumbent, a contender, or a hopeful, the direction of FDA regulation in this area is positive. Since the first iPad was launched, several types of healthcare software have moved from regulated to not regulated, and FDA’s guidance documents confirm that they intend to focus their enforcement resources on high-risk software products. If companies design their products in ways such that they are fairly described as not “active” or not “primary,” then the five “non-medical device” categories of the Cures Act will become the standard way to consciousl...
Source: MDDI - October 16, 2017 Category: Medical Devices Authors: Roger Cepeda Tags: Regulatory and Compliance Source Type: news

NanOlogy takes nanoparticle tech into Phase II trials
In the last two weeks, NanOlogy has launched trials evaluating its cancer-fighting paclitaxel nanoparticle suspension in patients with prostate cancer and in patients with ovarian cancer. The Texas-based company’s nanoparticle tech is based on a production process that cuts the size of chemotherapy crystals by up to 400 times, creating stable nanoparticles with increased surface area and unique geometry, NanOlogy explained. The particles do not require coating agents for stability and are suspended prior to use. Get the full story at our sister site, Drug Delivery Business News. The post NanOlogy takes nano...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Oncology Pharmaceuticals nanology Source Type: news

4 questions to ask about electronic informed consent
What is electronic informed consent? Informed Consent is a voluntary agreement to participate in research.  Clinical research professionals know that the informed consent process is more than just a signature on a form; it is a process of information exchange that may include:  providing subject recruitment materials, verbal instructions, question/answer sessions, time for the patient to read the form individually or with family members, and measures of subject understanding.  This is all in addition to actually signing the informed consent document.   Traditionally, paper-based consent has been the met...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

BrainStorm enrolls first ALS patient in late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that the first patients have been enrolled in its Phase III trial evaluating NurOwn as a treatment for amyotrophic lateral sclerosis, or ALS, at Massachusetts General Hospital and UC Irvine Medical Center. The trial, which is slated to enroll 200 patients, is designed to include the pre-specified patient subgroups who saw superior outcomes in the NurOwn Phase II ALS trial. BrainStorm said it expects top-line data from the trial in 2019. Get the full story at our sister site, Drug Delivery Business News. The post BrainStorm enrolls first ALS patient in late-stage NurO...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Stem Cells Wall Street Beat BrainStorm Cell Therapeutics Inc. Source Type: news

ReWalk Robotics aims for 2018 release for Restore softsuit robotic exoskeleton
ReWalk Robotics (NSDQ:RWLK) said today it completed all internal processes related to its Restore robotic rehabilitation softsuit exoskeleton and is ready to initiate clinical trials of the device in 2018, with hopes for a commercial launch in the same year. The Restore softsuit is designed to transmit power to key joints in the legs with cable technologies, powered by software and mechanics similar to those used in its ReWalk exoskeleton system for patients with spinal cord injuries. The cables are connect to fabric-based designs that attach to the leg and foot, and make it a ‘soft suit’, the Israel-...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Research & Development Robotics ReWalk Robotics Source Type: news

West Virginians Speak Out on Medical and Health Research (October 2017)
Results from an online survey of 403 West Virginian adults on the opioid epidemic, federal spending on medical and health research, STEM education, rural health research, health disparities, health information exchange, and clinical trials. (Source: HSR Information Central)
Source: HSR Information Central - October 16, 2017 Category: International Medicine & Public Health Source Type: news

Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: a randomized clinical trial demonstrating clinical utility - Bradley P, Shiekh M, Mehra V, Vrbicky K, Layle S, Olson MC, Maciel A, Cullors A, Garces JA, Lukowiak AA.
The objective of this study was to evaluate the effect of pharmacogenetics-guided treatment on patients diagnosed with depression and/or anxiety, in a diverse set of clinical settings, as compared to the standard of care. The trial design followed a prospe... (Source: SafetyLit)
Source: SafetyLit - October 14, 2017 Category: International Medicine & Public Health Tags: Program and Other Evaluations, Effectiveness Studies Source Type: news

With nod from panel, Aerie inches toward FDA approval
Aerie Pharmaceuticals (Nasdaq: AERI) – which is in the process of building out its research and development team locally – is moving closer to U.S. Food and Drug Administration approval. On Friday, an FDA advisory committee voted in favor of Rhopressa – an Aerie eye drop product candidate for the treatment of glaucoma. The 10-pe rson panel voted unanimously that clinical trials of Rhopressa support its efficacy; it voted 9-1 that its efficacy outweighs safety risks. While the FDA normally… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 13, 2017 Category: Biotechnology Authors: Jennifer Henderson Source Type: news

With nod from panel, Aerie inches toward FDA approval
Aerie Pharmaceuticals (Nasdaq: AERI) – which is in the process of building out its research and development team locally – is moving closer to U.S. Food and Drug Administration approval. On Friday, an FDA advisory committee voted in favor of Rhopressa – an Aerie eye drop product candidate for the treatment of glaucoma. The 10-pe rson panel voted unanimously that clinical trials of Rhopressa support its efficacy; it voted 9-1 that its efficacy outweighs safety risks. While the FDA normally… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 13, 2017 Category: Pharmaceuticals Authors: Jennifer Henderson Source Type: news

GSK Shingles Vaccine Shingrix Gets First Okay in Canada GSK Shingles Vaccine Shingrix Gets First Okay in Canada
Shingrix, given in two doses 2 to 6 months apart, is for adults aged 50 years and older. It was shown to achieve ≥ 90% efficacy in clinical trials.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 13, 2017 Category: Consumer Health News Tags: Infectious Diseases News Alert Source Type: news

FDA ’ s Shuren bullish on improved patient inclusion in trials at 1st PEAC meeting
The FDA is looking to step up its patient engagement efforts, FDA Center for Devices and Radiological Health Director Jeffrey Shuren said during the 1st meeting of the federal watchdog’s Patient Engagement Advisory Committee. Shuren said that with MDUFA IV, the agency is now better equipped to move forward with patient engagement efforts, according to a Regulatory Affairs Professionals Society report. “We’re now, for the first time, getting resources to build out a patient engagement group at CDRH. Prior to that, believe it or not, there were never dollars that had been allocated to us specifically for th...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

FDA advisory committee backs Aerie ’s Rhopressa eye drug
An FDA advisory committee voted today in favor of Aerie Pharmaceuticals‘ (NSDQ:AERI) Rhopressa product candidate. The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say that the product’s efficacy outweighs its safety risks, while one member voted against that claim. Get the full story at our sister site, Drug Delivery Business News. The post FDA advisor...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat Aerie Pharmaceuticals Source Type: news