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POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Researchers describe carcinogenic effects of EDCs

Longtime environmental health researchers at Tufts University School of Medicine describe the carcinogenic effects of endocrine-disrupting chemicals, ubiquitous chemicals that have hormone-like effects in the body. In a review article published online May 25 in Nature Reviews Endocrinology, the researchers express the need for more complex strategies for studying how these chemicals affect health but report that ample evidence already supports changing public health and environmental policies to protect the public from exposure to EDCs.

26 May 2010

Boston Scientific initiates study to compare PROMUS Element Stent to XIENCE PRIME Stent System

Boston Scientific Corporation today announced the initiation of the PLATINUM PLUS clinical trial, an investigator-sponsored research (ISR) study designed to compare the performance of the PROMUS® Element™ Everolimus-Eluting Coronary Stent System to the XIENCE PRIME™ Everolimus-Eluting Coronary Stent System.

26 May 2010

East African examines 10-year research program to address agriculture, food security, climate change in rural areas

The East African examines the Climate Change, Agriculture and Food Security program, a 10-year research collaboration between the Consultative Group on International Agriculture Research and the Earth System Science Partnership that aims to help rural communities address these issues (Butunyi, 5/24).

26 May 2010

$FDA warns on possible fracture risk with proton pump inhibitors use$

FDA warns on possible fracture risk with proton pump inhibitors use

The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

26 May 2010

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

Vertex Pharmaceuticals Incorporated today announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial.

26 May 2010

QIAGEN acquires rights to 70 molecular food safety tests developed by Institute for Product Quality

QIAGEN today announced that it has entered into an agreement with the Institute for Product Quality (ifp), pursuant to which QIAGEN has acquired all rights to 70 molecular food safety tests developed by the Berlin-based specialized laboratory center for food analysis.

From QIAGEN Manchester Limited 26 May 2010

Lumizyme receives FDA approval for patients with late-onset Pompe disease

The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

26 May 2010

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets. Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

26 May 2010

ALFA recognizes Emeritus Senior Living with 2010 Best of the Best Award

The Assisted Living Federation of America (ALFA) has awarded Emeritus Senior Living, headquartered in Seattle, Washington, its prestigious 2010 Best of the Best Award, a national recognition reserved for the nation's most innovative and effective business practices in the senior living industry. 2010 winners will be profiled in the May/June issue of ALFA's flagship magazine, Assisted Living Executive.

25 May 2010

Medtronic fiscal year 2010 revenue up 8% to $15.817 billion

Medtronic, Inc. today announced financial results for its fourth quarter and fiscal year ended April 30, 2010.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

Nutritious gluten-free breads for coeliac disease patients

Researchers at Teagasc Food Research Ashtown are producing tasty, nutritious gluten-free breads for coeliac disease sufferers. The research focused on using the so-called 'pseudocereals' amaranth, quinoa and buckwheat to replace wheat in bread formulations. These cereals are gluten-free, and are also rich in nutrients; therefore, their incorporation in the gluten-free diet could not only add variety but also improve nutritional quality.

25 May 2010

Genzyme signs consent decree of permanent injunction, agrees to disgorgement

Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced today.

25 May 2010

Family of EPA-registered disinfecting products to be launched

An innovative family of EPA-registered disinfecting products will be launched through a new direct selling company, it was announced today.

25 May 2010

DAPT Study expands into seven countries in the EU: HCRI

The Harvard Clinical Research Institute announced today that the DAPT Study has expanded into seven countries in the European Union. John Irving, MBChB, MRCP, M.D., consultant cardiologist at Ninewells Hospital in Dundee, United Kingdom, was the first European investigator to enroll patients into the study.

25 May 2010

NC Quantum Apex PTCA Dilatation Balloon Catheter receives CE Mark and FDA approval

Boston Scientific Corporation today announced CE Mark and U.S. Food and Drug Administration approval of its NC Quantum Apex PTCA Dilatation Balloon Catheter. The Company plans to launch the product in European markets this week and in the U.S. next month.

25 May 2010

Shah to discuss U.S. role in global agriculture at Food Security Investment Forum in Bangladesh

USAID Administrator Rajiv Shah will arrive in Bangladesh on Tuesday to participate in the Food Security Investment Forum and other meetings, All Headline News reports (5/23).

25 May 2010

Dermatologists recommend broad spectrum sunscreen products to protect against UVA and UVB rays

Sunscreen active ingredients, which are compounds that absorb, scatter or reflect ultraviolet (UV) light, are regulated as over-the-counter (OTC) drugs by the U.S. Food and Drug Administration (FDA).

25 May 2010

Combination therapy improves patients with depression symptoms: Study

New data presented today at the American Psychiatric Association's annual meeting suggests a benefit to combining L-methylfolate, a prescription medical food called Deplin, with an antidepressant at the start of treatment. This retrospective analysis showed a significantly greater improvement in depression symptoms in a shorter period of time, when patients with Major Depressive Disorder were started on combination therapy.

25 May 2010