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FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form.

11 Oct 2010

VBI researchers receive grant to study immune responses to gut pathogens

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has awarded a $10.6 million grant to researchers at the Virginia Bioinformatics Institute (VBI) and collaborators to determine how the human immune system responds to infection by pathogens of the gut. The funding will be used to apply mathematical modeling to the study of immune responses to gut pathogens.

11 Oct 2010

New experimental vaccine against Alzheimer's disease

Researchers at UT Southwestern Medical Center have created an experimental vaccine against beta-amyloid, the small protein that forms plaques in the brain and is believed to contribute to the development of Alzheimer's disease.

11 Oct 2010

Health insurance: Coverage expands for children, young adults; not necessarily for retirees

Glenn Franco, a retired community-college instructor in Michigan, tried to get his 24-year-old daughter on his health plan—and was turned away. Many large employers are telling retirees the same thing.

11 Oct 2010

Childcare centers address food allergies of ethnically diverse population

Attention to children's food allergies at childcare centers can be a life-or-death issue. As these centers wrestle with the problem, some also have unique needs to address, such as an ethnically diverse child population.

11 Oct 2010

American Specialty Health named to fastest-growing company list on 2010 Inc. 5000

Health and wellness company American Specialty Health Incorporated (ASH) was recently named to Inc. magazine's fourth annual list of the 5,000 fastest growing privately-held companies in the United States for a second consecutive year. The list is a comprehensive look at one of the most important segments of the economy—America's independent-minded entrepreneurs—and serves as a unique illustration of the profound changes taking place in the U.S. economy.

11 Oct 2010

Asia Pacific Conference on Tobacco addresses developing country smoking

American Public Media's "Marketplace" reports on the Asia Pacific Conference on Tobacco or Health, where experts from 41 countries discussed how the tobacco industry has "been been targeting developing countries more and more" (10/7).

11 Oct 2010

Ipsen announces sale of shares in PregLem Holding to Gedeon Richter

Ipsen today disclosed that it has sold its shares in PregLem Holding SA to Gedeon Richter Plc, as have all PregLem's other shareholders.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

Senate leaders eye temporary, one-month 'doc fix' for Medicare reimbursement

Congress Daily: "Senate leaders are eyeing a temporary, one-month patch for a looming Medicare physician pay cut, hoping to buy time to work out a longer-term fix despite pushing deadlines for a number of other provider reimbursement issues.

11 Oct 2010

UT Southwestern initiates study on hormone leptin for people with type 1 diabetes

A clinical trial at UT Southwestern Medical Center aims to determine whether adding the hormone leptin to standard insulin therapy might help rein in the tumultuous blood-sugar levels of people with type 1 (insulin-dependent) diabetes.

11 Oct 2010

Lifestyle interventions benefit overweight, obese and severely obese adults

Lifestyle interventions, including physical activity and structured weight loss programs, can result in significant weight loss for overweight, obese and severely obese adults, according to two reports that were posted online today by JAMA. The studies and accompanying editorials were made available early online to coincide with the presentation of these papers at the 28th Annual Scientific Meeting of the Obesity Society. The articles will appear in the October 27 print issue of JAMA.

11 Oct 2010

Charges and counter-charges on health law infiltrate political debates

CNN: "The two candidates vying for President Barack Obama's old Senate seat sat side-by-side and calmly accused each other of lying and other improprieties in a televised debate Sunday," on NBC's Meet the Press (Cohen, 10/10).

11 Oct 2010

University of Missouri creates National Botanical Research Center with $7.5M NIH grant

Americans spend $25 billion a year on dietary supplement products such as herbs and other botanicals. While the Nutrition Business Journal forecasts that sales of botanical dietary supplements will increase by about 19 percent over the next five years, scientists still don't know the precise properties that make certain plants helpful or harmful to humans. Now, with a new $7.5 million grant from the National Institutes of Health, University of Missouri researchers have created a National Botanical Research Center to answer these questions.

11 Oct 2010

Montreux invests $30 million in GCAL

Montreux Equity Partners, LLC, and GC Aesthetics, Ltd., today announced the completion of a US$30 million private equity investment by Montreux into GCAL. GCAL is a leading designer, manufacturer, and distributor of medical devices for the global aesthetics industry. Montreux entered into the financing agreement with GCAL to accelerate the company's expansion plans.

11 Oct 2010

Federal judge in Michigan rules health law constitutional

His decision rejected the "argument that Congress lacked the power to create the legislation's 'individual mandate,' which requires virtually all Americans to purchase health insurance," The Washington Post reports. "Other federal courts have already dismissed some challenges to the law on technical grounds — ruling, for instance, that the plaintiffs lacked standing.

11 Oct 2010

Progress in understanding mechanism behind photocontact allergy

What happens to sunscreens when they are exposed to sunlight? And how is the skin affected by the degradation products that form? This has been the subject of research at the University of Gothenburg and Chalmers University of Technology that will be presented at the upcoming dermatologist conference in Gothenburg.

11 Oct 2010

Research-based tip sheets provide details on breast cancer

Throughout October, National Breast Cancer Awareness Month, experts from Fred Hutchinson Cancer Research Center and its clinical care partner, the Seattle Cancer Care Alliance, are offering a series of weekly research-based tip sheets regarding a variety of topics related to breast cancer, including breast cancer prevention, screening and early detection, treatment, and survivorship.

11 Oct 2010

Philadelphia paramedics plan to sue over health coverage; healthcare merger seeks to lower costs in wash

The city's paramedics are planning to sue over Mayor Nutter's efforts to keep them out of the firefighters union. The dispute goes back to a ruling by the Pennsylvania Labor Relations Board last month that gave the city the right to shift paramedics out of the firefighters union.

11 Oct 2010

Exelixis enters two new collaboration agreements with Bristol-Myers Squibb

Exelixis, Inc. announced today that it has entered into two new collaboration agreements with Bristol-Myers Squibb Company. Under the first agreement, Exelixis will grant to Bristol-Myers Squibb an exclusive license to its small-molecule TGR5 agonist program including backups.

11 Oct 2010