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Clearance in Medical Technology

Project Zero Delay Accelerates Drug's Path to Clinical Trial

... two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human ... In addition, tasks usually done after FDA clearance of an Investigational New Drug (IND) application ... protocol to first patient in 46 days, with FDA clearance of the IND on day 44. Research elsewhere cited ...

Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles

... Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the ... and rhytids for skin phototypes I-IV. The clearance was granted based on clinical data demonstrating ... on the face through six months. "Today's FDA clearance of the Pelleve system represents a very exciting ...

Studies Show Combination Laser Therapy Effective At Clearing Acne, Reducing Oil Production

... 5-aminolevulinic acid provides long-lasting clearance of acne lesions. "Laser technology has made ... the ALA PDT treatment group experienced complete clearance of their acne. She reported that an average of ... alone or conventional therapy achieved complete clearance of their acne. "The first-of-a-kind study ...

PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications

... (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting ... The PEAK Surgery System, which received FDA clearance for use in general surgery in July 2008, includes ... in the first half of 2009. "With the FDA clearance of expanded surgical indications and ...

Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery

... C-Port system, and subject to receiving clearance of the PAS-Port system from the FDA, we will be ... has submitted a 510(k) premarket notification for clearance to market the PAS-Port system in the United ... with whether and when Cardica receives FDA clearance for the PAS-Port system, and the lack of ...

Cardium's Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack

... Control System(TM) has received FDA 510(k) clearance for use in inducing, maintaining and reversing ... modulation is expected to receive FDA clearance in the second quarter 2008, and to initially have the same clearance as the Celsius Control System. The RapidBlue ...

Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance

... Diagnostics subsidiaries have received FDA 510(k) clearance for two new point of care tests. The HemoCue(R) ... laboratories. The company also received FDA clearance for Focus Diagnostics' HerpeSelect(R) Express(TM) ... numerous conditions and disorders. With 510(k) clearance for marketing, physicians who operate ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... age. Renal impairment: Patients with creatinine clearance > or = 45 ml/min require no dose adjustment other ... for all patients. Use in patients with creatinine clearance below 45 ml/min is not recommended. See also ... secreted could potentially result in delayed clearance of pemetrexed. If necessary, ...

St. Francis Surgeon Uses Tissue Regeneration Technology to Rebuild Patients' Heart Structures

... products for cardiovascular applications. The company currently has U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair. For more information, visit ...

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

... stemming from this trial to support its 510(k) filing for marketing clearance with the United States Food and Drug Administration later this year. ... our 510(k) for DuraTech during the third quarter of 2009 and anticipate clearance of the product before the end of the year," said Sam Owusu-Akyaw, ...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial

... to be effective and well tolerated in stimulating mucus hydration and clearance in people with chronic obstructive lung diseases. In particular, Bronchitol has been shown to increase mucus clearance from the lungs and significantly improve quality of life for people with ...

Medarex Announces Preclinical Data from Multiple Research Programs Demonstrating Anti-Tumor Activity in Cancer

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology

... technique for prostate cancer. A regulatory application for FDA 510(k) clearance of InnerCool's UroCool(TM) catheter is expected to be submitted in the ... system. We plan to submit a regulatory application for FDA 510(k) clearance for the new UroCool(TM) catheter this month," stated Christopher J. ...

Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma

... 2 /PRNewswire/ -- Aerovance Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines ... fractional concentration of expired nitric oxide (FeNO). "Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and ...

Update of Long-Term Data on Brain Cancer Patients Receiving DCVax(R)-Brain Continues to Show Striking Improvements in Delay of Disease and Survival

... patients at 11 sites across the U.S. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

Synvista Therapeutics Announces Published Data Demonstrating Elevation of Carboxymethyl-Lysine (CML) Is Associated with Decline in Renal Function and Arterial Stiffness in Older Adults

... clinical diagnostic assay as it prepares to submit a CML kit for 510(k) clearance in the second half of 2009. "These studies represent an important ... Synvista Therapeutics. "We believe that a clinical diagnostic test, upon clearance by the FDA, to measure CML levels may one day provide these patients and ...

Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Long-Term Phase I and Phase I/II Trial Data Continue to Show Striking Improvement in Survival of Brain Cancer Patients Who Receive DCVax(R)-Brain

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Medarex Highlights Strength in Antibody Development and Underlying Pipeline Strategy at R&D Day Event in New York City

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Positive Mid-Term Results on CryoValve(R) SG Pulmonary Human Heart Valve Presented at Western Thoracic Meeting

... valve received market clearance from the FDA in February 2008. The market clearance was supported by documenting the substantial equivalence of the CryoValve ... throughout the United States and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using ...

Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test

... to the U.S. Food & Drug Administration (FDA) requesting regulatory clearance of its Ovarian Tumor Triage Test known as OVA1(TM). As announced ... and CEO of Vermillion. "We also look forward to receiving regulatory clearance from the FDA and making OVA1 available to the hundreds of thousands of ...

Intellect Neurosciences, Inc. and Medical Research Council Technology (U.K.) Reach Important Milestone in Generating an Alzheimer's Therapeutic Antibody

... of Alzheimer's disease. The antibody is intended to be used to promote clearance from the brain of beta amyloid, the toxin that leads to Alzheimer's ... available to bind to the endogenous beta-amyloid toxin, thus promoting its clearance away from the brain. This therapeutic outcome can be achieved either by ...

Interim Phase 1/2 Data of Ipilimumab in Prostate Cancer Presented at American Society of Clinical Oncology Annual Meeting

... will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting

... No. 442673, Sunday, May 18, 8:00 a.m. - 5:00 p.m., Sails Pavilion. clearance of HCV at 5 Year Follow-Up for Peginterferon Alfa-2b with or without ... thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min. Avoid Pregnancy REBETOL therapy should not be ...

Intercell AG to Acquire Iomai Corporation to Expand Late Stage Product Pipeline and Strengthen Leadership in Vaccine Innovation

... is subject to customary closing conditions including antitrust clearances, clearance by the Committee on Foreign Investment in the United States and the ... to be held as soon as practical, receipt of antitrust clearances and clearance by the Committee on Foreign Investment in the United States. Intercell and ...

Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis

... or whether other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting

... after peginterferon alfa-2b and ribavirin treatment predicts long-term clearance of HCV at 5-year follow-up. Manns, M. et al. Platelet count predicts ... thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min. Avoid Pregnancy REBETOL therapy should not be ...

Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting

... or whether other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

Synvista Therapeutics Presents New Preclinical Data Demonstrating the Value of Haptoglobin Genotype Testing In Diabetes at ACC Scientific Sessions

... mice with the Haptoglobin 2-2 genotype that show impairment in the clearance of the Haptoglobin (Hp)-Hemoglobin (Hb) complex may result in a ... patients (Hp2-2) with vitamin E." In the study, researchers assessed clearance of Hb by Hp in diabetic mice that were also tested for Hp type. The study ...

Phase I and Phase I/II DCVax(R)-Brain Data Continues to Show Significantly Improved Survival Rates for Brain Cancer Patients

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has ...

InterCure Announces 100,000th RESPeRATE Unit Sold

... advocacy and consumer awareness began to take hold following the OTC clearance of the device. The second 50,000 units were sold in just 15 months. Growth ... in most key international markets (including FDA over-the-counter ("OTC") clearance in the U.S., the European CE mark and the Chinese SDA among others) and a ...

Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis

... Fifth Disease Indication for HUMIRA Provides Patients with Visible clearance of Inflamed Skin Lesions Caused by Chronic Autoimmune Disease ABBOTT ... and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of ...

Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania

... and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company also ...

Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342

... succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. ...

FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer

... that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of ... multi-center clinical trial was conducted to validate the expanded clearance for CellSearch. The study, which took place in 55 clinical centers in the ...

Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure

... is believed to relate to diminished affinity for the natriuretic peptide clearance receptor and increased resistance to the enzyme neutral endopeptidase, both pathways for clearance of endogenous natriuretic peptides. In animal models, PL-3994 was able to ...
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(Date:8/20/2014)... 20, 2014 George E. Fox, a John and Rebecca ... Houston (UH), was named a fellow in the International Society ... , Fox is one of four members two from ... chosen as fellows in 2014. Fellows are elected every three ... than 500 members from more than 20 countries, the ISSOL ...
(Date:8/20/2014)... LAKE CITY Researchers at Huntsman Cancer Institute (HCI) at ... forms of the gene that encodes BCR-ABL, the unregulated ... According to the American Cancer Society, nearly 6,000 new ... Drugs already in use, called tyrosine kinase inhibitors (TKIs), ... They do not cure CML but control it in ...
(Date:8/20/2014)... /CNW/ -  Issue Serious allergic reactions ... life threatening for some children.    What you ... have food allergies and this number may be increasing, especially ... estimated to have food allergies.  The symptoms ... hives to breathing difficulties and loss of consciousness. Symptoms can ...
Breaking Biology News(10 mins):UH professor named fellow by International Astrobiology Society 2Blueprint for next generation of chronic myeloid leukemia treatment 2Information Update - Allergens and food safety at school - What's in your child's lunch? 2Information Update - Allergens and food safety at school - What's in your child's lunch? 3
(Date:8/21/2014)... -- Not only is eating better and exercising healthy for ... dollars a year, a new study finds. The study, ... at Wake Forest Baptist Medical Center in Winston-Salem, N.C., ... patients. Participants ranged in age from 45 ... "lifestyle change program" focused on diet and exercise, or to ...
(Date:8/21/2014)... Dennis Thompson HealthDay Reporter ... combination of therapy and antidepressants appears to best help ... reports. Four out of five people suffering from ... recovery when treated with cognitive therapy plus antidepressant medication, ... didn,t work much better than drugs alone in helping ...
(Date:8/21/2014)... 2014 A new study published this ... in disability associated with speech problems from 2001-02 to ... 15% increase in disability associated with hearing problems. The ... numbers of children who are experiencing communication disorders, according ... , On a broader level, the new study, ...
(Date:8/21/2014)... Many primary care physicians in rural communities do ... (IPV), according to Penn State medical and public ... such violence have limited resources if they seek ... to help women," said Jennifer S. McCall-Hosenfeld, a ... and public health sciences, Penn State College of ...
(Date:8/21/2014)... New York (PRWEB) August 21, 2014 ... blood thinner caused patients to suffer uncontrollable internal bleeding ... courts, Bernstein Liebhard LLP reports. According to court documents, ... in U.S. District Court, Easter District of New York ... due to a bleeding event that was allegedly caused ...
Breaking Medicine News(10 mins):Health News:Getting Healthier a Big Money-Saver for People With Diabetes 2Health News:Talk Therapy Plus Meds May Be Best for Severe Depression 2Health News:Talk Therapy Plus Meds May Be Best for Severe Depression 3Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 2Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 3Health News:Primary care physicians can be critical resource for abused women in rural areas 2Health News:Xarelto Lawsuits Mount With New Filing in New York Federal Court, Bernstein Liebhard LLP Reports 2Health News:Xarelto Lawsuits Mount With New Filing in New York Federal Court, Bernstein Liebhard LLP Reports 3Health News:Xarelto Lawsuits Mount With New Filing in New York Federal Court, Bernstein Liebhard LLP Reports 4
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