Clinical - Approvals News: Breaking Clinical - Approvals News, Comments and Articles. - Page: 3

Smile Perfected 20 Minute Whitening System Supports the American Dental Association's Preference of Dental Supervision During Treatments

ORLANDO, Fla., May 23, 2013 /PRNewswire/ -- The teeth whitening experts at SmilePerfected.com have announced their approval and support of the American Dental Association (ADA) considerations paper discussing tooth whitening treatment considerations.  Smile Perfected feels it is very important that a dentist and the dental team are involved in the treatment decision for a patient conside...

One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after one year. The new one year study data from the EnligHTN I trial was presented today at EuroPCR 2013 in Paris.

Verenium To Present At Two Upcoming Conferences

SAN DIEGO, May 23, 2013 /PRNewswire/ -- Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that Jeffrey Black, Chief Financial Officer, will present at two upcoming conferences. (Logo: http://photos.prnewswire.com/prnh/20120924/MM79973LOGO) Mr. Black will present at the...

Intercept Pharmaceuticals to Present at Deutsche Bank Healthcare Conference

NEW YORK, May 23, 2013 /PRNewswire/ -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, such as primary biliary cirrhosis, today announced that Mark Pruzanski, MD, President and Chief Executive Officer, will present at the Deut...

Zensun Announces Positive Clinical Results for Neucardin™ to Improve Heart Function and Reduce Mortality in Chronic Heart Failure Patients

SAN DIEGO and SHANGHAI, May 23, 2013 /PRNewswire/ -- Zensun Sci & Tech, Ltd., a biopharmaceutical company based in Shanghai and San Diego, announced today positive results of four completed Phase 2 clinical trials including three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the United States Phase 2 trial for Zensun's in...

MannKind's Afrezza And The Oramed Threat

ByCory Renauer:My last article concerning MannKind Corp. (MNKD) was a discussion of how its Afrezza will succeed where Pfizer's (PFE) Exubera failed. I still believe it can, but I didn't give MannKind's competitive landscape as much attention as I should have. A recent article here, makes a fairly bold statement about an orally administered insulin capsule that will "sweep past" the efforts of Man...

Medtronic's In.Pact Falcon Drug-Eluting Balloon Yields Positive Outcomes in Small Coronary Arteries

Presented at EuroPCR, One-Year Data from BELLO Study Show Durability of Clinical Results Following Treatment of De Novo Lesions with Novel Angioplasty Device PARIS -- May 23, 2013 -- One-year data from an Italian multicenter randomized controlled trial of the IN.PACT Falcon drug-eluting balloon from Medtronic, Inc. (NYSE: MDT) demonstrate positive and durable clinical results with the novel ang...

Guest blog: Cell therapy approval and reimbursement must pace in synch within the modern scenarios

Cell therapy approval and reimbursement must pace in synch within the modern scenarios. Gil Van Bokkelen, Athersys CEO, and Micheal Werner, Alliance for Regenerative Medicine [...]

Aeterna Zentaris: Posters to be Presented on Phase 1 and Phase 2 Trials with AEZS-108 in Prostate and Breast Cancer at Upcoming ASCO Meeting

QUÉBEC CITY, May 23, 2013 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the following posters will be presented on AEZS-108, the Company's lead oncology compound, at the upcoming American Society of Clinical Oncology ("ASCO") annual meeting, which will be held May 31 to June 4, 2013, in Chicago. Abstract # 5062:...

Johnson & Johnson Pharmaceuticals Segment Poised to Continue Driving Growth with More than 10 Potential New Product Filings by 2017

NEW BRUNSWICK, N.J., May 23, 2013 /PRNewswire/ -- At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017. To view the multimedia assets associated with this release, please click: http://www...

OrphanReach: Healthcare at Home and QED partner on orphan diseases

Healthcare at Home and QED partner on orphan diseases OrphanReach alliance will see companies provide product lifecycle services Healthcare at Home and QED Clinical Services [...]

Biogen Idec seeks FDA approval for Plegridy in multiple sclerosis therapy

Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication.

Pusan National University Announces Science Translational Medicine Publication Highlighting Landmark Demonstration of Functional Anti-Cancer Antibody Induction in Patients Following JX-594 Treatment

BUSAN, South Korea, May 23, 2013 /PRNewswire/ -- Pusan National University Yangsan Hospital, in collaboration with SillaJen, Inc., a private biotherapeutics and contract research company focused on research and development of targeted biological products for cancer, announced today a publication reporting the induction of functional anti-cancer antibodies in patients treated with the oncolytic and...

Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease

SEATTLE, May 23, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases tha...

Contract Research Organization WCCT Global Announces Strong Focus on Diabetes Clinical Trials

With the rise of Diabetes, WCCT Global is focusing energy on Diabetes clinical trials. Costa Mesa, CA (PRWEB) May 23, 2013 WCCT Global, a full-service contract research organization headquartered in Southern California announces today, a strong focus on diabetes research. WCCT Global has been building a patient database for years now and has had a steady flow of possible participants interested i...

Critical Response Systems Announces New Solution Designed to Overcome Alarm Fatigue

Critical Response Systems (CRS), a provider of leading-edge, mission-critical communication systems, announced today that the company has developed a solution to relieve “alarm fatigue” in hospitals. Norcross, GA (PRWEB) May 23, 2013 Critical Response Systems (CRS), a provider of leading-edge, mission-critical communication systems, announced today that the company has developed a solution to...

More Baby Boomers Rejected by Long Term Care Insurance Companies

LTC Tree, the number one “virtual” seller of Long Term Care Insurance in the industry, has launched a Health and Wellness section on their website designed to help clients reduce the risk that they will need to use their Long Term Care Insurance policy. LTC Tree Health provides the latest research and information on nutrition, fitness, mental health, and aging to encourage consumers to make he...

Race and gender of study personnel affect clinical-research participation

Race and gender of study personnel affect clinical-research participation

Cardiologist Density and Outcomes

Patients who have an MI or develop heart failure in a part of the country with a low density of practicing cardiologists have a slightly higher risk of death at 30 days and one year compared with those who have the same clinical events in an area...

OncoGenex Announces Plans for the Initiation of the Cedar™ Clinical Trial Evaluating OGX-427 in Combination with Chemotherapy in Advanced Squamous Cell Lung Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, May 23, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer. This trial will be the seventh...

Manchester nuclear hormone research approach is a UK first

Researchers and doctors from Manchester institutes have joined forces with pharmaceutical company GlaxoSmithKline (GSK) to launch an innovative joined-up approach to tackling chronic inflammatory disease. The creation of the Manchester Centre for Nuc...

Advanced Bionics Announces the Commercial Release of the Naída CI Q70 Sound Processor in Europe, Canada and Several Other Countries around the World

-- The World’s Newest, Most Advanced Behind-the-Ear Sound Processor Receives Regulatory Approval for Commercial Release in Europe and Canada -- Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the new Naída CI Q70* (Naída CI) sound processor

PAREXEL International To Present At Jefferies Healthcare Conference

BOSTON, May 23, 2013 /PRNewswire/ -- PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the Jefferies Healthcare Conference in New York.  James Winschel, Sr. Vice President and Chief Financial Officer, will be making a presentation on PAREXEL and discussing business developments at 1:30 p.m. ET on Monday, June 3, 2013. A live webcast of t...

BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress

BOTHELL, Wash., May 23, 2013 /PRNewswire/ -- BioLife Solutions, Inc. (OTC:BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced its participation at the Terrapinn World Stem Cells & Regenerative Medicine Congress 2013 this week...

InspireMD's MGuard Embolic Protection Stent (EPS) Shows Lower Mortality Rate in STEMI Patients at Six Months Compared to Control Group

PARIS, May 23, 2013 /PRNewswire/ -- InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), the leader in embolic protection stents, today announced new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation...