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Indoor tanning devices: AADA testifies before FDA panel on needed classification changes and calls for ban

American Academy of Dermatology Association (AADA) President and dermatologist William D. James, MD, FAAD, along with other dermatologists and leading researchers today testified before a Food and Drug Administration (FDA) panel considering changes to the current classification of indoor tanning devices. Currently, the FDA classifies indoor tanning devices as Class 1, the category for items that have minimal potential to cause harm to individuals. Items in Class 1 include adhesive bandages and tongue depressors.

27 Mar 2010

New study may give men a way to combat high cholesterol without drugs

A new study from Iowa State University's Nutrition and Wellness Research Center may give men a way to combat high cholesterol without drugs -- if they don't mind sprinkling some flaxseed into their daily diet.

27 Mar 2010

FDA considers tightening restrictions on tanning beds

The Food and Drug Administration may tighten restrictions on tanning beds "amid evidence they raise the risk of skin cancer beyond exposure to ultraviolet radiation from the sun," The Wall Street Journal reports.

27 Mar 2010

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Graceway® Pharmaceuticals announced today that the Food and Drug Administration has approved the New Drug Application for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.

27 Mar 2010

Recent releases in Global Health

"Sub-Saharan Africa is affected by a disproportionately high prevalence of both HIV infection and food scarcity," write the authors of an American Journal of Clinical Nutrition article on the relationship between malnutrition and the progression of HIV/AIDS. "Underweight individuals will continue to represent a significant proportion of patients who present for HIV care in sub-Saharan Africa.

27 Mar 2010

Health Canada accepts Cipher Pharmaceuticals' NDS for CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced that its New Drug Submission (NDS) to Health Canada for CIP-TRAMADOL ER, its extended-release formulation of tramadol, has been accepted for review. The Company expects the review to be completed by early 2011.

26 Mar 2010

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing.

26 Mar 2010

ADVENTRX Pharmaceuticals to meet FDA to review its NDA for ANX-530

ADVENTRX Pharmaceuticals, Inc. today announced that it will meet the U.S. Food and Drug Administration in Washington D.C. during the last week of April 2010 to review the Company's New Drug Application for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.

26 Mar 2010

AngioScore receives FDA marketing clearance for PTA Scoring Balloon Catheter

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AngioSculpt® PTA Scoring Balloon Catheter for dilatation of lesions in renal arteries.

26 Mar 2010

FDA Advisory Committee to review VIVUS' NDA for Qnexa

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration is tentatively scheduled to review the Company's New Drug Application for Qnexa® for the treatment of obesity on July 15, 2010.

26 Mar 2010

BLS acquires AMPAKINE compounds from Cortex Pharmaceuticals

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL, has acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. for use in the field of respiratory depression, a brain-mediated breathing disorder.

26 Mar 2010

Ontario nurses welcome 1.5% increase in hospital funding

Ontario nurses welcome the 1.5 per cent increase in hospital funding outlined in the Ontario budget, and say this means government and employers must now fast track the promised 9,000 additional nurses to ensure patients receive the quality care they need and deserve.

26 Mar 2010

MGH to create registry of patients who had OCT of coronary arteries

Massachusetts General Hospital, together with a coalition of 20 international sites in five countries, will create the world's largest registry of patients who have had optical coherence tomography of the coronary arteries.

26 Mar 2010

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Santarus, Inc., a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, as part of the budesonide MMX Phase III clinical program for U.S. registration.

26 Mar 2010

New research may help advance treatment strategies for common liver disease

A research article published in the journal PloS Pathogens could lead to improvements in the production of vaccines for hepatitis A, the most widespread viral disease in the world.

26 Mar 2010

Top behavior problems of elderly parents

IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay granted EUA from FDA

IMDx announced today that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization from the U.S. Food and Drug Administration.

26 Mar 2010