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FDA accepts Handa's generic DEXILANT ANDA for review

Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration.

2 Mar 2011

FDA clears Meridian's illumigene C. difficile molecular amplification test

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration for a new pediatric claim for its illumigene C. difficile molecular amplification test. C. difficile is a bacterium that is frequently associated with antibiotic therapy often causing diarrhea and, in severe cases, a life-threatening inflammation of the colon.

2 Mar 2011

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

GTx, Inc. today announced that the company and Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.

2 Mar 2011

NEI/FDA conference to analyze functional vision outcomes from clinical trials of visual prostheses

The National Eye Institute and Food and Drug Administration are sponsoring a conference to determine how functional vision-related endpoints for clinical trials of visual prostheses will be analyzed and correlated with objective measures of visual acuity, visual fields and contrast sensitivity.

2 Mar 2011

Dietitians of Canada releases new nutritional website

Dietitians of Canada today launched Nutrition Month 2011 with the release of Cook! This brand new Canadian treasure is a dazzling collection of 275 satisfying recipes, 32 mouth-watering food photographs, nutrition tips and practical family cooking lessons.

2 Mar 2011

UH Ahuja Medical Center officially opens its doors to patients on March 2

University Hospitals Ahuja Medical Center – the first new stand-alone hospital in Cuyahoga County in 30 years –officially opens its doors to patients on March 2.

2 Mar 2011

CDA launches new awareness campaign about risk of developing type 2 diabetes

Today, the Canadian Diabetes Association launched "Get Checked Now" - a national public awareness campaign aimed at Canadians 40 and older alerting them to the consequences of being passive about their potential risk for developing type 2 diabetes and leading them to take action against the disease by getting checked now.

2 Mar 2011

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

March designated as Nutrition Month

The OPDQ is pleased that March has once again been designated as Nutrition Month. Across Quebec and the rest of Canada, dieticians/nutritionists will be holding events and activities aimed at raising public awareness about the importance of a healthful diet and teaching people how to maintain or improve their health by eating right.

2 Mar 2011

Thermo Fisher Scientific plans for new manufacturing facility in China

Thermo Fisher Scientific Inc., the world leader in serving science, today announced plans for a new manufacturing facility in China within the Suzhou Science and Technology Town - part of the company's strategy to aggressively expand its presence in the Asia-Pacific region.

From Thermo Fisher Scientific Inc. 2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

From Baxter International Inc. 2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Thirty organizations call on Congress to reverse cuts to life-saving programs in the U.S. budget

A coalition of 30 Christian and Jewish organizations in the U.S. have joined together with the ONE Campaign to urge senators now considering fiscal 2011 budget measures to reverse the disproportionate and devastating cuts to international assistance approved by House lawmakers last week.

2 Mar 2011

Good oral health habits begin even before the first baby teeth appear

For many parents, thoughts of their children's dental health often comes long after the first baby teeth appear. Yet a lifetime of good oral health habits begins even with toothless infants, says Dr. Louis Amendola, D.D.S., Chief Dental Director at Western Dental Services, Inc.

2 Mar 2011

Wako receives FDA 510(k) clearance for uTASWako i30 with AFP-L3 and DCP assays

Wako Diagnostics, a division of Wako Chemicals USA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA.

2 Mar 2011

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

The Institute for OneWorld Health (iOWH) announced a major milestone in the fight against cholera. The Food and Drug Administration (FDA) granted iOWH permission to begin phase 1 trials for iOWH032, a drug to treat secretory diarrhea. This is the first submission of an Investigational New Drug application for a completely new chemical entity by a non-profit of this size to receive such rapid FDA clearance, and it could be the first synthetic drug of its kind for diarrheal diseases.

2 Mar 2011

Nations meet to negotiate international food aid terms

A group of nations are meeting in London this week to negotiate the Food Aid Convention (FAC), an "international agreement that governs food-aid commitments to hungry countries," the Globe and Mail reports. Argentina, Australia, Canada, the European Union and its member states, Japan, Norway, Switzerland and the U.S. currently are included in the convention, which was last updated in 1999.

2 Mar 2011

FDA clears Valeritas' V-Go Disposable Insulin Delivery Device for use with NovoLog

Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the U.S. Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for use with Novo Nordisk's NovoLog for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin.

1 Mar 2011

European Commission approves BMY's BARACLUDE(r) to treat CHB in adult patients with liver disease

Bristol-Myers Squibb announced today that BARACLUDE(R) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B in adult patients with evidence of decompensated liver disease.

1 Mar 2011

Food News and Research

FDA accepts Handa's generic DEXILANT ANDA for review

FDA clears Meridian's illumigene C. difficile molecular amplification test

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

NEI/FDA conference to analyze functional vision outcomes from clinical trials of visual prostheses

Dietitians of Canada releases new nutritional website

UH Ahuja Medical Center officially opens its doors to patients on March 2

CDA launches new awareness campaign about risk of developing type 2 diabetes

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

March designated as Nutrition Month

Thermo Fisher Scientific plans for new manufacturing facility in China

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Thirty organizations call on Congress to reverse cuts to life-saving programs in the U.S. budget

Good oral health habits begin even before the first baby teeth appear

Wako receives FDA 510(k) clearance for uTASWako i30 with AFP-L3 and DCP assays

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

Nations meet to negotiate international food aid terms

FDA clears Valeritas' V-Go Disposable Insulin Delivery Device for use with NovoLog

European Commission approves BMY's BARACLUDE(r) to treat CHB in adult patients with liver disease

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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