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FDA issues warning letters to three companies for claiming plaque removal by mouth rinse products

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

29 Sep 2010

Further trials needed to determine clinical application of Abatacept in SLE

Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

29 Sep 2010

Oakley grants $1 million to YSC to assist young women with breast cancer

Young Survival Coalition (YSC) is proud to announce that Oakley, Inc.'s support of YSC has exceeded $1 million. YSC is the premier global organization dedicated to providing education, resources and hope to young women who are diagnosed with breast cancer.

29 Sep 2010

Former Geisinger head to run CMS Innovation Center

CQ HealthBeat reports that Richard Gilfillan, a former head of the Geisinger Health Plan in Pennsylvania, will run the Center for Medicare and Medicaid Services Innovation Center that was created by the health law. Gilfillan was chosen Monday. At Geisinger, Gilfillan ran a plan that "many health policy analysts see as a national model for delivering quality, affordable care" (Reichard, 9/27).

29 Sep 2010

New disposable, microfluidic PDMS device for identification of advanced breast cancer

A new disposable device based on advances in microfluidics may help identify advanced breast cancer patients who are candidates for therapy with the drug trastuzumab (Herceptin). The device is described in the American Institute of Physics' journal Biomicrofluidics.

29 Sep 2010

Researchers identify biomarkers for mesothelioma and pancreatic cancer

Using a novel aptamer-based proteomics array technology, researchers and collaborators have identified biomarkers and protein signatures that are hallmarks of cancer at an early stage for two of the most aggressive and deadly forms of cancer, pancreatic and mesothelioma.

29 Sep 2010

Medicare Advantage plans draw attention

The Boston Globe: "Harvard Pilgrim Health Care has notified customers that it will drop its Medicare Advantage health insurance program at the end of the year, forcing 22,000 senior citizens in Massachusetts, New Hampshire, and Maine to seek alternative supplemental coverage." The reason is that federal reimbursements for such plans have been frozen, and Harvard's particular Advantage product, a private fee-for-service plan, would have to develop a network of contracted providers for the first time under the new rules (Weisman, 9/28).

29 Sep 2010

RV262 Phase I study launched to evaluate DNA prime/MVA vector boost vaccine regimen for HIV

A Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost vaccine regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa and South America.

29 Sep 2010

Saudi FDA approves Apligraf for treatment of diabetic foot ulcers, chronic wounds

Organogenesis, Inc. announced that its Apligraf® bilayered living cellular construct has been approved for the treatment of diabetic foot ulcers and other chronic wounds by the Saudi Food and Drug Authority (SFDA) of the Kingdom of Saudi Arabia. Apligraf is a living cell based product used by physicians to heal chronic wounds in patients in the U.S. and around the world.

29 Sep 2010

HUYA, Quintiles announce agreement to develop HBI-8000 cancer drug

HUYA Bioscience International, the leader in U.S.-China pharmaceutical co-development, and Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today announced an agreement to co-develop a new cancer drug, HBI-8000, sourced in China by HUYA.

29 Sep 2010

Scientists to identify microbial risk predictors for preterm birth

A team of scientists from Mayo Clinic, the University of Illinois at Urbana-Champaign, and the J. Craig Venter Institute are leveraging a long-standing research relationship to apply results from the Human Microbiome Project to help identify microbial risk predictors for preterm birth.

29 Sep 2010

NIH grants Akonni $3M for development of multi-drug resistant/extensively drug-resistant genotyping test

Akonni Biosystems, a molecular diagnostics company that develops, manufactures, and plans to market sophisticated genetic testing devices for complex infectious and human diseases, today announced receipt of a nearly $3 million Challenge Grant from the National Institutes of Health (NIH), a new program made possible under the American Recovery and Reinvestment Act (ARRA).

29 Sep 2010

Escalon Medical reports 0.2% increase in product revenue for fiscal year 2010

Escalon Medical Corp. today announced results for its fiscal year ended June 30, 2010. Consolidated product revenue from continued operations for fiscal 2010 increased approximately 0.2% to $30,657,000, compared with $30,600,000 in the prior fiscal year.

29 Sep 2010

Text: The Republican 'Pledge' on health care

With an eye on the midterm elections, Republicans in the House of Representative released "A Pledge to America" -- an outline of what they plan to do if they gain control of Congress.

29 Sep 2010

Hypertension drug market to decline by $3 billion in 2019: Decision Resources

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that, owing to increasing generic availability of antihypertensive agents, the hypertension drug market will decline from $26 billion in 2009 to $23 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

29 Sep 2010

NCI awards A&G $1.2M Phase II SBIR grant for development of breast cancer drug candidate

A&G Pharmaceutical announced today that it has received $1.2 million in Phase II Small Business Innovation Research (SBIR) funding from the National Cancer Institute (NCI) for the program, "Novel Targeted Therapy for Breast Cancer," focused on the development of a neutralizing therapeutic antibody against a novel cancer-associated protein, GP88.

29 Sep 2010

ADLS receives $1.5M from exercise of unit warrants

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced it has received $1.5 million of proceeds from the exercise of the unit warrants issued in the public offering of securities announced on July 1, 2010.

29 Sep 2010

Today's Opinions: Challenging health law critics' words; The case for Calif. health exchange; Holes in the GOP pledge

If critics really want to go back to the days when insurance companies ran wild with no accountability, they should have the courage to say so openly instead of hiding behind distracting attacks. In the meantime, we're going to keep standing up for American families and small business owners who deserve a system that works for them (Health and Human Services Secretary Kathleen Sebelius, 9/28).

29 Sep 2010

Firefly stem cells may help doctors to heal damaged hearts: Research

Stem cells that glow like fireflies could someday help doctors heal damaged hearts without cutting into patients' chests.In his University of Central Florida lab, Steven Ebert engineered stem cells with the same enzyme that makes fireflies glow. The "firefly" stem cells glow brighter and brighter as they develop into healthy heart muscle, allowing doctors to track whether and where the stem cells are working.

29 Sep 2010

SGC releases 1000th high resolution protein structure

The Structural Genomics Consortium (SGC), an international public private partnership that aims to determine three dimensional structures of medically important proteins, announced today the release into the public domain of its 1000th high resolution protein structure.

29 Sep 2010