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PA State Police, PCCD join national effort to collect medications on Sept. 25

Pennsylvanians are urged to turn in expired, unused and unwanted prescription medications at collection sites statewide during the first National Prescription Drug Take-Back Day on Saturday, Sept. 25, State Police and the Pennsylvania Commission on Crime and Delinquency said today.

22 Sep 2010

Gen-Probe submits PMA to FDA for PROGENSA PCA3 assay

Gen-Probe announced today that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer.

22 Sep 2010

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Apricus Biosciences, backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud's syndrome secondary to scleroderma.

22 Sep 2010

Study: College women with heavy roommates gain less weight during freshman year

A new University of Michigan study finds that college women with roommates who weigh more than average gain less weight during their freshman year than women with slimmer roommates: half a pound versus 2.5 pounds.

22 Sep 2010

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Boston Scientific Corporation today announced data from its PLATINUM QCA study, which is designed to evaluate the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent. The results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the PROMUS Element Stent.

22 Sep 2010

Palomar Medical Technologies to introduce home-use laser device for cosmetic treatments

Palomar Medical Technologies Inc., a leading researcher and developer of light-based systems for cosmetic treatments, today announced that it would move the launch of its patented, home use laser for the treatment of periorbital wrinkles by a few months.

22 Sep 2010

Secretary-General opens U.N. summit on MDGS with appeal for world leaders to maintain target commitments

On the first of the three-day U.N. Summit on the Millennium Development Goals (MDGs), U.N. Secretary-General Ban Ki-moon on Monday appealed "to the assembled presidents, prime ministers and kings to use their power to meet U.N. goals to help the world's poorest by 2015," the Associated Press reports.

22 Sep 2010

Study: Doctors who are overweight or lack training are reluctant to counsel patients about diet, exercise

Physician's confidence in their abilities to counsel patients on a healthy diet and exercise may be related to their own personal habits, according to a study by the University of Michigan Cardiovascular Center.

22 Sep 2010

FDA grants orphan-drug designation to Catalyst's CPP-115 investigational drug

Catalyst Pharmaceutical Partners, Inc. today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been granted orphan-drug designation for the treatment of infantile spasms (West Syndrome) by the U.S. Food and Drug Administration (FDA).

22 Sep 2010

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

PROMUS Element Stent receives expanded indications approval for high-risk diabetic and AMI patient groups

Boston Scientific Corporation today announced that its PROMUS® Element™ Everolimus-Eluting Coronary Stent System has received CE Mark approval for use in patients with diabetes and those experiencing an acute myocardial infarction (AMI), or heart attack.

21 Sep 2010

Health Canada issues license for IgX PLEX Celiac test kit

SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that Health Canada has issued a medical device license for its automated IgX PLEX Celiac(TM) microarray test kit that runs on the Company's automated SQiDworks(TM) platform. The license allows the Company to market and sell the IgX PLEX Celiac product in Canada.

21 Sep 2010

FDA grants orphan drug designation for MultiStem stem cell therapy

Athersys, Inc. announced today that MultiStem, Athersys' multipotent adult progenitor stem cell therapy, has been granted orphan drug designation by the U. S. Food and Drug Administration for the prevention of graft vs. host disease (GvHD).

21 Sep 2010

FDA approves Mylan's generic Prograf Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

21 Sep 2010

New MTWA technology is integrated in Quinton Q-Stress cardiac stress systems

Cambridge Heart, Inc., a developer of noninvasive diagnostic tests for cardiac disease, today announced the launch of its Microvolt T-Wave Alternans (MTWA) technology as an integrated part of industry-leading cardiac stress test systems manufactured and distributed by Cardiac Science Corporation. The MTWA technology, which can predict a patient's risk of sudden cardiac arrest (SCA), is now being offered to new and existing users of Cardiac Science's Quinton Q-Stress cardiac stress systems.

21 Sep 2010

Social exclusion induces people to spend money and consume in service of affiliation

People who feel excluded will go to any length to try to become part of a group, even if it involves spending large sums of cash, eating something dicey, or doing illicit drugs, according to a new study in the Journal of Consumer Research.

21 Sep 2010

USAID, GAIN announce $1 million to reduce malnutrition burden

The United States Agency for International Development (USAID) and the Global Alliance for Improved Nutrition (GAIN) announced today $1 million to expand efforts to reduce the growing burden of malnutrition. The announcement will be made today at a historic gathering of the First Ladies of Africa, who convened to declare nutrition as a critical priority for eliminating poverty, improving health and advancing food security in their nations.

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Multinational study demonstrates positive effects of laquinimod in patients with RRMS

Teva Pharmaceutical Industries Ltd. and Active Biotech today announced results from a 36-week active extension study evaluating two doses of laquinimod, an investigational, once-daily oral immunomodulator, for the treatment of relapsing remitting multiple sclerosis.

21 Sep 2010

Researchers renew call for governmental agencies to identify BPA products

Researchers have discovered that women, female monkeys and female mice have major similarities when it comes to how bisphenol A (BPA) is metabolized, and they have renewed their call for governmental regulation when it comes to the estrogen-like chemical found in many everyday products.

21 Sep 2010

Food News and Research

PA State Police, PCCD join national effort to collect medications on Sept. 25

Gen-Probe submits PMA to FDA for PROGENSA PCA3 assay

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Study: College women with heavy roommates gain less weight during freshman year

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Palomar Medical Technologies to introduce home-use laser device for cosmetic treatments

Secretary-General opens U.N. summit on MDGS with appeal for world leaders to maintain target commitments

Study: Doctors who are overweight or lack training are reluctant to counsel patients about diet, exercise

FDA grants orphan-drug designation to Catalyst's CPP-115 investigational drug

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

PROMUS Element Stent receives expanded indications approval for high-risk diabetic and AMI patient groups

Health Canada issues license for IgX PLEX Celiac test kit

FDA grants orphan drug designation for MultiStem stem cell therapy

FDA approves Mylan's generic Prograf Capsules ANDA

New MTWA technology is integrated in Quinton Q-Stress cardiac stress systems

Social exclusion induces people to spend money and consume in service of affiliation

USAID, GAIN announce $1 million to reduce malnutrition burden

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Multinational study demonstrates positive effects of laquinimod in patients with RRMS

Researchers renew call for governmental agencies to identify BPA products

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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