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Gen-Probe to merge industrial testing assets into an independent company

Gen-Probe Incorporated announced today that it is spinning off its industrial testing assets into a new, independent company focused on developing rapid, highly accurate molecular assays for biopharmaceutical production, water and food safety testing, and other applications.

14 Sep 2009

Final results of SAPHRIS clinical study released

Schering-Plough Corporation today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study.

14 Sep 2009

GENova to file for Prostaganin patents in the US and in Europe

GENova Biotherapeutics Inc. ("GENova") today announced that it is preparing for patent application filings in both the US (at the FDA (U.S. Food and Drug Administration (www.fda.gov) for a 510(k) submission) and in Europe through EMEA (European Medicines Agency) subsequent to expected efficacious and non-toxic pre-clinical results for Prostaganin.

14 Sep 2009

Chinese SFDA approves Abbott's XIENCE V drug eluting stent for treating coronary artery disease

Abbott (NYSE: ABT) announced today that the Chinese State Food and Drug Administration (SFDA) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD) - the leading cause of death in China. XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS(R) Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, pivotal (phase III) clinical trials.

14 Sep 2009

Mylan Pharmaceutical's ANDA for Teva's Copaxone accepted by FDA (Correction)

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/mL), a generic version of Teva's Copaxone(R), a product indicated for the treatment of multiple sclerosis.

14 Sep 2009

Multi-topic, hour-long series hosted by a cardiac surgeon premiers today

"The Dr. Oz Show," a high octane, multi-topic hour-long series hosted by trusted health expert, best-selling author, and world-renowned cardiac surgeon Dr. Mehmet Oz, premieres in syndication today (check local listings). Episodes airing during its premiere week feature two of the recently announced "Core Team Oz" guest contributors, fashion and style expert Tim Gunn ("Project Runway") and fitness specialist Bob Harper ("The Biggest Loser"). Also debuting this week as a member of Core Team Oz is "America's vet," Dr. Marty Becker, the popular author and regular veterinary contributor on ABC-TV's "Good Morning America."

14 Sep 2009

FDA to consider an additional labelling claim for Noveko's masks and respirators

Noveko International Inc. ("the Company") is pleased to announce that further to its request, the Food and Drugs Administration (the "FDA") accepted to meet with the Company, to consider an additional labelling claim for its Noveko(TM) masks and respirators.

14 Sep 2009

GTx to continue its toremifene Phase III high grade PIN clinical trial for prevention of prostate cancer

GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate.

14 Sep 2009

POS website for one-stop paper shopping experience

POSPaper.com, the Internet’s premier source for point-of-sale supplies, paper products, and accessories, has expanded its website to include a “Restaurant Supplies” section as well as one-stop paper shopping for restaurants, retailers, banks, casinos, resorts, grocers, and more.

14 Sep 2009

Schizophrenia: A major public health problem

Schizophrenia is a major public health problem. Affecting almost 1% of the world's population, it takes an enormous economic and social toll in addition to the distress, dysfunction, disability and mortality for those afflicted with this disease. Elements of the disease are present from birth, other aspects emerge during developmental years, and the illness becomes fully expressed in early adulthood with long-lasting implications for most patients.

14 Sep 2009

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

14 Sep 2009

Eat healthy foods to prevent flu

As flu season grips the nation with heightened awareness of hand washing and cough covering, healthy eating is a potent prevention method getting left out in the cold.

14 Sep 2009

Communities can make an impact on childhood obesity rates

Parents strive to help children stay fit and healthy. Now, a new report says local government should do its part, too.

14 Sep 2009

Acid reflux in children is often overlooked: Director of PAGER Association

The Pediatric Adolescent Gastroesophageal Reflux (PAGER) Association has been helping families learn about acid reflux since 1992. The medical name for the disease is gastroesophageal reflux. It means stomach + esophagus + backwash.

14 Sep 2009

Trabedersen granted orphan drug designation from both FDA And EMEA for treating pancreatic carcinoma

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received orphan drug designation from both the European Medicines Agency EMEA and the US Food and Drug Administration FDA for its investigational drug trabedersen in the treatment of pancreatic carcinoma.

14 Sep 2009

Quest Diagnostics' OVA1 ovarian cancer test cleared by the FDA

The U.S. Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

From Quest Diagnostics 14 Sep 2009

FDA approves Theravance's VIBATIV for treating complicated skin and skin structure infections

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

14 Sep 2009

Laquinimod study data reveals its neuroprotective and anti-inflammatory properties

Teva Pharmaceutical Industries Ltd. and Active Biotech today presented data further illuminating the novel, dual mechanism of action (MOA) of investigational oral, once-daily, laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS), conferring neuroprotective and anti-inflammatory properties.

14 Sep 2009

Recent releases: HIV and nutrition; new global health journal; male circumcision; Chagas disease; malaria research methods

"Despite calls from national and international organizations to integrate HIV and nutritional programs, data are lacking on how such programs can be effectively implemented in resource-poor settings, on the optimum content and duration of nutritional support, and on ideal target recipients," write the authors of a Clinical Infectious Diseases review that examines the relationship between HIV, nutritional deficiencies and food insecurity.

14 Sep 2009

Study estimates economic benefits of lowering sodium consumption

Reducing Americans' average intake of sodium to the amount recommended by health officials could save the nation as much as $18 billion annually in avoided health care costs and improve the quality of life for millions of people, according to a new RAND Corporation study.

14 Sep 2009