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Government investigators pinpoint $5.6 billion in 'suspect' Medicare billings from pharmacies

This report from the Health and Human Services inspector general concluded that corner drugstores are vulnerable to fraud.

11 May 2012

$EC approves CTI’s Pixuvri to treat multiply relapsed or refractory aggressive NHL$

EC approves CTI’s Pixuvri to treat multiply relapsed or refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it has received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas.

11 May 2012

TherapeuticsMD introduces third prescription prenatal vitamin

TherapeuticsMD, Inc., parent company of vitaMedMD, LLC, a specialty pharmaceutical company, announced that on May 10, 2012 it launched its third prescription prenatal vitamin, vitaMedMD RediChew Rx, following the successful launch of vitaMedMD One Rx earlier this month and vitaMedMD Plus Rx last month.

11 May 2012

Eisai, Arena announce expansion of lorcaserin marketing and supply agreement

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.

11 May 2012

Cardionovum to introduce two DEB dilatation catheter product families

Cardionovum GmbH will launch two drug-eluting balloon (DEB) dilatation catheter product families at next week's EuroPCR 2012 congress: Paclitaxel-coated drug-eluting balloons for coronary and peripheral applications.

11 May 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

Georgia Tech project to design new warehousing and storage system for vaccines, drugs

The Georgia Institute of Technology has received a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation. The program funds individuals worldwide to explore ideas that can break the mold in how persistent global health and development challenges are solved.

10 May 2012

BBI from soybeans shows promise against cancer

Soybeans soaking in warm water could become a new "green" source for production of a cancer-fighting substance now manufactured in a complicated and time-consuming industrial process, scientists are reporting in ACS' Journal of Agricultural and Food Chemistry.

10 May 2012

Newly diagnosed schizophrenia patients continue to use oral Abilify as first-line therapy

BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that analysis of U.S. longitudinal patient-level claims data reveals the use of Bristol-Myers Squibb's oral Abilify as a first-line therapy for newly diagnosed schizophrenia patients continues to grow.

10 May 2012

NCATS initiative to use abandoned experimental drugs for other uses 'a step in the right direction'

The National Institutes of Health's (NIH) National Center for Advancing Translational Science (NCATS) -- a new plan to help speed drug development by making abandoned experimental drugs available to researchers who can look for alternative uses -- "is an indication that the Obama administration and the medical research enterprise are thinking out of the box," Michael Manganiello, a partner at HCM Strategists, writes in a Huffington Post "Politics Blog" opinion piece.

10 May 2012

Researchers use clever screening methods to speed vaccine production

Infectious diseases-both old and new-continue to exact a devastating toll, causing some 13 million fatalities per year around the world. Vaccines remain the best line of defense against deadly pathogens and now Kathryn Sykes and Stephen Johnston, researchers at Arizona State University's Biodesign Institute, along with co-author Michael McGuire from the University of Texas Southwestern Medical Center are using clever functional screening methods to attempt to speed new vaccines into production that are both safer and more potent.

10 May 2012

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

Today Biogen Idec announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis.

10 May 2012

Treatment with IL-12 triggers T cell exhaustion in cancer patients

Rather than stimulating immune cells to more effectively battle cancerous tumors, treatment with the protein interleukin-12 (IL-12) has the opposite effect, driving these intracellular fighters to exhaustion, a Mayo Clinic study has found.

10 May 2012

$Women with spine fractures can benefit from alendronate therapy$

Women with spine fractures can benefit from alendronate therapy

Continuing a popular but controversial treatment for osteoporosis could reduce spine fracture risk for a particular group of patients, but others could see little to no change if they discontinue it. Based on available evidence, a UCSF researcher reevaluated his 2006 finding from a randomized 10-year study of alendronate, a type of bisphosphonate - a class of drugs that prevent loss of bone mass.

10 May 2012

Discovery Labs reports data from SURFAXIN preclinical study on RDS

Discovery Laboratories, Inc., a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, reported that data from a preclinical study of SURFAXIN LS (lyophilized KL4 surfactant) was recently published in the May issue of Pediatric Research.

10 May 2012

Chronic exposure to cocaine drives structural changes in the brain

Chronic exposure to cocaine reduces the expression of a protein known to regulate brain plasticity, according to new, in vivo research on the molecular basis of cocaine addiction. That reduction drives structural changes in the brain, which produce greater sensitivity to the rewarding effects of cocaine.

10 May 2012

G&D, IAVI and GMI partner to develop new HIV/AIDS vaccine

The International AIDS Vaccine Initiative (IAVI), GlycoMimetics, Inc. (GMI), and Glycosensors and Diagnostics, LLC (G&D) today announced a collaboration to develop an AIDS vaccine using novel compounds that mimic carbohydrates, called glycomimetics.

10 May 2012

FDA AAC recommends approval of Pfizer’s tofacitinib for RA

Pfizer Inc. announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

10 May 2012

Warfarin may not be as effective in elderly women with AF

Older women who have been diagnosed with an irregular heart beat are at higher risk of stroke than men. A new study led by the Research Institute of the McGill University Health Centre (RI MUHC) shows that warfarin, the most common anticoagulant therapy used to prevent stroke in patients with Atrial fibrillation (AF) may not be as effective in women, 75 years or older, as in men.

10 May 2012

Shire, Cosmo and Giuliani International file suit against Watson over generic Lialda

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Mesalamine Delayed-release Tablets, 1.2g. Watson's ANDA product is a generic version of Shire Development LLC's Lialda.

10 May 2012