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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

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010

HHS awards Sanofi Pasteur 3-year, $56.94M egg supply contract for pandemic vaccine preparedness

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, has been awarded a three-year contract for $56.94 million by the U.S. Department of Health and Human Services (HHS) to maintain flocks to enable manufacturing pandemic influenza vaccine at full capacity on a year-round basis.

11 Oct 2010

Abbott to withdraw sibutramine from Canadian market

Abbott will voluntarily withdraw sibutramine from the Canadian market after discussion with Health Canada. Sibutramine is marketed by Abbott in Canada as Meridia.

11 Oct 2010

Drugs may prevent temporary combativeness in children after surgery

Temporary combativeness after surgery-a complication affecting up to half of anesthetized children-may be preventable with drugs that decrease epinephrine production, according to a Medical College of Georgia pediatric anesthesiologist.

11 Oct 2010

Takeda, Envoy enter three-year research alliance to develop schizophrenia drug

Takeda Pharmaceutical Company Limited, a global pharmaceutical company, and Envoy Therapeutics Inc., a recently formed drug discovery company, today announced that they have formed a three-year research alliance aimed at discovering drugs for schizophrenia that will have greater efficacy and safety compared to current therapies.

11 Oct 2010

Abbott to withdraw Meridia medicine from the U.S. market

Abbott will voluntarily withdraw Meridia (sibutramine) from the U.S. market at the request of the U.S. Food and Drug Administration (FDA).

11 Oct 2010

Researchers create experimental vaccine for 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

Meridia – weight loss pill off the shelves in US

Abbott Pharmaceuticals has announced the withdrawal of weight loss drug Meridia from shelves in the United States and urged patients to stop taking it after regulators questioned its safety. The withdrawal happened last Friday in the US. In January, Meridia sales were suspended in Europe.

10 Oct 2010

Weight loss pill off shelves due to heart attack risk

Final verdict on a popular weight loss drug Reductil is to be delivered today. It is being debated whether the pill should be taken off the shelves in Australia and New Zealand. The drug Sibutramine sold as Reductil is linked to increased risk of heart attacks.

10 Oct 2010

Biologists determine three-dimensional structure of molecule involved in HIV, cancer

In a technical tour de force, structural biologists funded by the National Institutes of Health have determined the three-dimensional structure of a molecule involved in HIV infection and in many forms of cancer. The high-resolution structure sheds light on how the molecule functions and could point to ways to control its activity, potentially locking out HIV and stalling cancer's spread.

8 Oct 2010

Suneva Medical publishes Artefill data for treatment of atrophic acne scars

Suneva Medical, a privately-held aesthetic medical device company, today announced the publication of an open-label, single center, pilot study on Artefill for the treatment of atrophic acne scars conducted by James M. Spencer, M.D. M.S. and sponsored by Suneva Medical.

8 Oct 2010

CMA to apply intervener status in Insite case

The Canadian Medical Association (CMA) Board of Directors has decided that the CMA will apply for intervener status before the Supreme Court of Canada in its pending appeal of a case involving Insite, the supervised injection facility in Vancouver, British Columbia.

8 Oct 2010

MRSA pathogen influences U.S. physician drug selection for treating skin structure infections

Arlington Medical Resources (AMR), a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that methicillin-resistant Staphylococcus aureus (MRSA) is the most concerning pathogen to surveyed U.S. physicians with regard to their treatment of skin and skin structure infections.

8 Oct 2010

Spanish mothers more concerned about the safety of childhood vaccines

Researchers from the University of Alicante (UA) taking part in the European VACSATC project have studied mothers' and fathers' opinions on vaccinating their children in five countries. The results of the survey show that Spanish mothers are more resistant than those in other countries to the idea of paying for vaccines, while 20.9% expressed some concern about the safety of vaccines.

8 Oct 2010

CDC issues new universal influenza vaccination recommendation for all Americans

With the influenza vaccine already available and more supply anticipated than ever before, the National Foundation for Infectious Diseases convened ten of the country's leading medical and public health groups to call on all Americans to get vaccinated this season.

8 Oct 2010

IV ibuprofen effective in reducing fever in hospitalized patients

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.

8 Oct 2010