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Novus Scientific's TIGR Matrix Surgical Mesh receives FDA marketing approval

Novus Scientific Pte. Ltd today announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the TIGR™ Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists. TIGR™ Matrix Surgical Mesh is a 100 percent resorbable, synthetic matrix, knitted from two different resorbable fibers that degrade at different rates following implantation.

5 Feb 2010

Voila helps restore and set up public safety communication networks in Haiti relief efforts

Haiti telecom operator Voila has been busy since the January 12 earthquake providing local and international service to over a million Haitian customers and thousands of incoming relief workers. However, Voila technicians are also assisting a host of agencies – from the US Coast Guard to international NGOs – to set up or restore public safety communications networks and to launch new text services tailored specifically for disaster relief.

5 Feb 2010

Making relationship between evolution and ecology - a model of reciprocity, say experts

In the natural stream communities of Trinidad, guppy populations live close together, but evolve differently. Upstream, fewer predators mean more guppies but less food for each; they grow slowly and larger, reproduce later and less, and die older. Downstream, where predators thrive, guppies eat more, grow rapidly, stay small, reproduce quickly and die younger.

5 Feb 2010

FDA investigates Salmonella Montevideo outbreak in Italian sausage products

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

5 Feb 2010

Study: More than 100,600 people receive emergency food each year through Eastern Illinois Foodbank

On Tuesday, representatives of the Eastern Illinois Foodbank shared results of a national study sponsored by Feeding America, the nation's largest domestic hunger-relief organization. The study is completed every four years by nearly 200 food banks and analyzes the effectiveness of emergency food distribution throughout the United States.

5 Feb 2010

FDA awards highest quality rating for Carol Milgard Breast Center

The Carol Milgard Breast Center was awarded the highest quality review possible by the Food and Drug Administration (FDA) for adhering to the most rigorous quality and safety standards set forth by the Mammography Quality Standards Act (MQSA).

5 Feb 2010

New report finds low adult vaccination rates in U.S.

A new report, Adult Immunization: Shots to Save Lives, released today by the Trust for America's Health (TFAH), the Infectious Diseases Society of America (IDSA), and the Robert Wood Johnson Foundation (RWJF) found that more than 30 percent of adults ages 65 and older had not been immunized against pneumonia in 36 states as of 2008.

5 Feb 2010

Mylan first to file ANDA patent for Caduet Tablets

Mylan Inc. today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg.

5 Feb 2010

U.N. taps Bill Clinton to lead Haiti rebuilding; 200,000 people died in quake, Haitian PM says

U.N. Secretary-General Ban Ki-moon on Wednesday asked former President Bill Clinton, currently the U.N. special envoy for Haiti, to oversee aid and rebuilding efforts in Haiti, CNN reports (2/3).

5 Feb 2010

Patients with mild gallstone pancreatitis can be operated within 48 hours of admission

Patients with mild gallstone pancreatitis usually stay in the hospital for several days, waiting for the symptoms to subside, before undergoing surgery to remedy the condition. A new study from researchers at Los Angeles Biomedical Research Institute (LA BioMed) indicates patients may no longer have to wait so long for surgery and could leave the hospital sooner.

5 Feb 2010

Low-cost soy chicken offers numerous health benefits

Sure, some delicacies might taste just like chicken, but they usually feel and look much different. Soy meat alternatives, such as the soy burger, have become more popular recently, with increased sales of eight percent from 2007 to 2008.

5 Feb 2010

Opinions: G8 and maternal, child mortality; rebuilding Haiti

In a National Post opinion piece, Canadian Member of Parliament Keith Martin, "who chaired the drafting committee at the 2009 G8 International Parliamentarians' Conference in Rome, which put together a plan of action to reduce maternal and infant mortality," welcomes the recent announcement by Canadian Prime Minister Stephen Harper that maternal and child mortality will be a focus of the G8 summit this summer.

5 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

Aradigm Corporation announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix”) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system. The Company will receive quarterly royalty payments on all SUMAVEL DosePro sales. In 2006, the Company sold all assets related to the Intraject* needle-free injector technology (now rebranded as DosePro) to Zogenix in exchange for milestone and royalty payments.

5 Feb 2010

St. Jude Medical receives European approval for Fortify ST ICD and Unify CRT-D defibrillators

St. Jude Medical, Inc. today announced European CE Mark approval and first implants of its Fortify™ and Fortify ST implantable cardioverter defibrillators (ICD) and Unify™ cardiac resynchronization therapy defibrillator (CRT-D). The devices will be fully launched in Europe later this spring, and U.S. versions of the Fortify ICD and Unify CRT-D are expected to be launched later this year. The reduced size of these new devices compared to those of previous generations creates the smallest available device footprint in the industry.

5 Feb 2010

Polymedco's automated immunoassay fecal occult blood test system receives FDA clearance

Polymedco, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis.

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Isotechnika Pharma Inc. today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM).

4 Feb 2010

FDA approves first laser treatment for stretch marks

Palomar Medical Technologies, Inc. is pleased to announce that the Lux1540™ Fractional non-ablative laser handpiece has received the first clearance by the United States Food and Drug Administration (FDA) for the treatment of striae (stretch marks) using a fractional laser. This new clearance will allow aesthetic practitioners to treat the millions of women worldwide who have unwanted stretch marks.

4 Feb 2010

"Knowledge deficit" about methadone responsible for resulting deaths

In a unique and comprehensive literature review of poisoning deaths involving opioids from 1999 -- 2009, the deaths involving methadone were found to be disproportionately high. Methadone represented less than five percent of all opioid prescriptions but is responsible for a third of the deaths. After four years of investigation, the major underlying cause was found to be fundamental misunderstandings about the properties of the medicine -- a "knowledge deficit" -- especially when converting patients from other opioids.

4 Feb 2010

Food News and Research

Novus Scientific's TIGR Matrix Surgical Mesh receives FDA marketing approval

Voila helps restore and set up public safety communication networks in Haiti relief efforts

Making relationship between evolution and ecology - a model of reciprocity, say experts

FDA investigates Salmonella Montevideo outbreak in Italian sausage products

Study: More than 100,600 people receive emergency food each year through Eastern Illinois Foodbank

FDA awards highest quality rating for Carol Milgard Breast Center

New report finds low adult vaccination rates in U.S.

Mylan first to file ANDA patent for Caduet Tablets

U.N. taps Bill Clinton to lead Haiti rebuilding; 200,000 people died in quake, Haitian PM says

Patients with mild gallstone pancreatitis can be operated within 48 hours of admission

Low-cost soy chicken offers numerous health benefits

Opinions: G8 and maternal, child mortality; rebuilding Haiti

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

St. Jude Medical receives European approval for Fortify ST ICD and Unify CRT-D defibrillators

Polymedco's automated immunoassay fecal occult blood test system receives FDA clearance

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

FDA approves first laser treatment for stretch marks

"Knowledge deficit" about methadone responsible for resulting deaths

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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