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MassBiologics gets FDA orphan drug designation for MBL-HCV1 antibody

MassBiologics of the University of Massachusetts Medical School has received an orphan drug designation from the U.S. Food and Drug Administration for MBL-HCV1, a monoclonal antibody developed to prevent hepatitis C virus recurrence in patients receiving a liver transplant.

5 Dec 2013

Researchers discover how PC7 protein affects certain types of cognitive performance

A team of Montr-al researchers at the IRCM led by Dr. Nabil G. Seidah, in collaboration with Dr. William C. Wetsel's team at Duke University in the United States, discovered that the protein PC7 plays a critical role in the brain by affecting certain types of cognitive performance such as anxiety, learning and emotional memory. Their results, recently published in the scientific journals Proceedings of the National Academy of Sciences (PNAS) and Nature, could have a significant impact on regulating behaviour related to anxiety disorders and trauma.

4 Dec 2013

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company's Gencaro Investigational New Drug application for atrial fibrillation has been accepted by the U.S. Food and Drug Administration and is now active.

4 Dec 2013

Food expert to hold talk on healthy eating

Food expert Dr Nazanin Zand is taking her healthy eating message into the community with a talk to parents and young people in Kent.

4 Dec 2013

Scientists explore new ways to tackle obesity

Scientists are attempting to tackle obesity by exploring ways of helping people stay healthy.

4 Dec 2013

FDA grants QIDP status to Astellas' isavuconazole for treatment of invasive aspergillosis

Astellas Pharma US, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis.

4 Dec 2013

Linagliptin as monotherapy or in combination with metformin reduces blood glucose levels in T2D patients

Boehringer Ingelheim and Eli Lilly and Company today announced new data from a Phase IV study evaluating linagliptin (5 mg) as monotherapy and in combination with metformin (1500 or 2000 mg) in treatment-naive adults with newly diagnosed (<12 months) uncontrolled Type 2 Diabetes.

4 Dec 2013

Study indicates that black neighborhoods have limited access to healthy foods

When it comes to health, you are what you eat, as the adage goes. But many Americans have little choice in the matter, with race being an even bigger determinant than poverty.

4 Dec 2013

U.S. physicians use CSI's Diamondback 360 Coronary OAS for coronary artery disease treatment

Cardiovascular Systems, Inc., today announced that its new Diamondback 360 Coronary Orbital Atherectomy System is being used by physicians across the country to treat coronary artery disease. This follows the company's recent PMA approval from the U.S. Food and Drug Administration to market the device as a treatment for severely calcified coronary arteries.

3 Dec 2013

LabCorp's HCV GenoSure NS3/4 test now available for Q80K polymorphism screening

Laboratory Corporation of America Holdings announced today the immediate availability of an enhanced version of its HCV GenoSure NS3/4, a drug resistance test that screens for the Q80K polymorphism. Q80K is a naturally occurring polymorphism that develops in certain strains of HCV, making the virus less susceptible to Janssen Therapeutics' OLYSIO (simeprevir), which was recently approved by the U.S. Food and Drug Administration for the treatment of certain adult patients diagnosed with genotype 1chronic hepatitis C.

3 Dec 2013

Researchers find way to replace Paneth cells with two small molecules that maintain stem cells

Researchers at MIT and Brigham and Women's Hospital have shown that they can grow unlimited quantities of intestinal stem cells, then stimulate them to develop into nearly pure populations of different types of mature intestinal cells. Using these cells, scientists could develop and test new drugs to treat diseases such as ulcerative colitis.

3 Dec 2013

FDA clears Cochlear Baha 4 Attract System for use in the U.S.

Cochlear Limited, the global leader in implantable hearing solutions, announced that the US Food and Drug Administration cleared the Cochlear Baha 4 Attract System for use in the United States. Cochlear is the only company to now offer patients a choice of either a magnetic or a direct bone conduction hearing solution.

3 Dec 2013

PrimeraDx gets FDA clearance for ICEPlex C. difficile Assay Kit and ICEPlex System

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex C. difficile Assay Kit and the ICEPlex System have received 510(k) clearance from the United States Food and Drug Administration.

3 Dec 2013

Religious liberty issues color Supreme Court consideration of health law's contraception coverage mandate

The Supreme Court in early spring will hear two legal challenges to Obamacare's contraception coverage requirement, a case that addresses a complex question that has never come squarely before the court: Can a for-profit company engaged in commercial activities declare religious beliefs?

3 Dec 2013

Reimbursement cuts for image-guided breast biopsies may reduce women's access to mammography

Drastic reimbursement cuts for image-guided breast biopsies, and other medical imaging techniques in the 2014 Medicare Fee Schedule Final Rule, may further reduce women's access to mammography and other breast cancer services. The Centers for Medicare and Medicaid Services directly cut imaging reimbursement every year since 2007. This, along with 12 Medicare imaging cuts in the last six years due to legislation, increasingly threatens patient care.

3 Dec 2013

Experts explain how to prevent heartburn during holidays

Attracted by the decadent treats, fried meats, and festive cocktails of the Thanksgiving-to-New-Year feast, heartburn can be an unwelcome guest during the holidays. According to the American Society for Gastrointestinal Endoscopy, acid reflux affects about 30 million Americans.

3 Dec 2013

Gore receives Shonin approval from Japan to market GORE C3 Delivery System

W. L. Gore & Associates, Inc. has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE EXCLUDER AAA Endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm.

3 Dec 2013

Evidence reveals bronchial thermoplasty has long-term benefit for asthma patients

The beneficial effects of bronchial thermoplasty, a non-pharmacologic treatment for asthma, last at least five years, according to researchers at National Jewish Health and other institutions.

3 Dec 2013

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.

3 Dec 2013

Virginia Mason first to use non-invasive FibroScan technology to evaluate liver diseases

Virginia Mason today becomes the first in the Pacific Northwest to use non-invasive FibroScan technology to evaluate disease stage in patients diagnosed with liver ailments.

3 Dec 2013

Food News and Research

MassBiologics gets FDA orphan drug designation for MBL-HCV1 antibody

Researchers discover how PC7 protein affects certain types of cognitive performance

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

Food expert to hold talk on healthy eating

Scientists explore new ways to tackle obesity

FDA grants QIDP status to Astellas' isavuconazole for treatment of invasive aspergillosis

Linagliptin as monotherapy or in combination with metformin reduces blood glucose levels in T2D patients

Study indicates that black neighborhoods have limited access to healthy foods

U.S. physicians use CSI's Diamondback 360 Coronary OAS for coronary artery disease treatment

LabCorp's HCV GenoSure NS3/4 test now available for Q80K polymorphism screening

Researchers find way to replace Paneth cells with two small molecules that maintain stem cells

FDA clears Cochlear Baha 4 Attract System for use in the U.S.

PrimeraDx gets FDA clearance for ICEPlex C. difficile Assay Kit and ICEPlex System

Religious liberty issues color Supreme Court consideration of health law's contraception coverage mandate

Reimbursement cuts for image-guided breast biopsies may reduce women's access to mammography

Experts explain how to prevent heartburn during holidays

Gore receives Shonin approval from Japan to market GORE C3 Delivery System

Evidence reveals bronchial thermoplasty has long-term benefit for asthma patients

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Virginia Mason first to use non-invasive FibroScan technology to evaluate liver diseases

The future is bioengineered: Synthetic biology and global sustainability eBook

Improving healthcare sustainability through carbon data

Managing vibration in IVF laboratories

A New Approach to Preventing Bladder Cancer Recurrence

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