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Unapproved cyanide antidote kits seized from Keystone Pharmaceuticals

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.

23 Jul 2010

Nestle announces collaborative study with Cleveland Clinic Lerner Research Institute on diet rich in whole grains

Nestle USA Chairman and CEO Brad Alford has announced that Nestle Research Center, based in Lausanne, Switzerland, has donated US $500,000 to Cleveland Clinic's Lerner Research Institute. The gift will fund a collaborative study focused on examining the effects of a diet rich in whole grains on body composition and energy metabolism.

23 Jul 2010

FDA approves Mylan's ANDA for generic Solodyn ER tablets for acne treatment

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan Pharmaceuticals Inc. commenced immediate shipment of the product after approval.

23 Jul 2010

FDA approves Impax's ANDA for generic OPANA ER 30mg tablet

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.

23 Jul 2010

Poor intake of vitamins tends to have low bone density in children with celiac disease

Children with celiac disease need to include certain must-have vitamins in their diets to stave off weak bones and osteoporosis, say researchers at the University of Alberta. A study of 43 children and teens from three to 18 years of age diagnosed with celiac disease showed that they also tended to have low bone density, likely due to poor intake and absorption of vitamins and minerals. That means they should be getting more of bone-boosting vitamins such as K and D in their diets, says Diana Mager, a professor of agricultural, food and nutritional science at the U of A, and one of the researchers on the project.

23 Jul 2010

Three toxins in food identified as triggers to gluten intolerance: study

Coeliac disease cause by intolerance to gluten present in food and drinks like bread, pasta, cereals, biscuits and beer commonly affects many people all over the world. This affects 1 percent of all people in UK, especially women. Patients are advised to stay away from gluten to prevent damage to their intestines. In spite of this in five years most patients develop problems in their intestines. A gluten free diet is also difficult to maintain. Possible symptoms include diarrhoea, nausea and vomiting, recurrent stomach pain, tiredness, headaches, weight loss and mouth ulcers. These may be mild, moderate or severe in different individuals.

22 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Baxter second-quarter global sales increase 2% to $3.2 billion

Baxter International Inc. today announced its financial results for the second quarter of 2010, reporting earnings in line with the company's previously issued guidance of $0.90 to $0.93 per diluted share.

From Baxter International Inc. 22 Jul 2010

Alexion second-quarter non-GAAP net income increases 56% to $36.9 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2010.

22 Jul 2010

New understanding on insulin resistance, action of diabetes drugs may lead to safer medication

A new understanding of insulin resistance and the action of diabetes drugs such as Avandia and Actos could pave the way for improved medications that are more selective and safer, say scientists from Dana-Farber Cancer Institute and The Scripps Research Institute.Our findings strongly suggest that good and bad effects of these drugs can be separated by designing second-generation drugs that focus on the newly uncovered mechanism, said Bruce Spiegelman, PhD, of Dana-Farber, senior author on a report appearing in the July 22 issue of Nature.

22 Jul 2010

Fatal risk of software defects in implantable medical devices

Software vulnerabilities in life-sustaining medical devices such as pacemakers and infusion pumps pose a growing threat to public health, warns a new report published by the Software Freedom Law Center (SFLC).

22 Jul 2010

Strong feelings alter one's ability to resist temptations: Study

While it may be convenient to add in a trip to the grocery store after a good workout at the gym, a recent study confirms it may not be the best idea for your waistline.The study in the current issue of the Journal of Consumer Research indicates mood, positive or negative, has a noticeable effect on the choices made by consumers. Co-authors Alexander Fedorikhin, of Indiana University's Kelley School of Business Indianapolis, and Vanessa Patrick, of the University of Houston, conducted three experiments to show how strong feelings alter one's ability to resist temptations.

22 Jul 2010

Burden of funding, driving research on rare diseases too often falls upon patients, families: NORD

An advocate for people with rare diseases today told a U.S. Senate committee that the burden of funding and driving research on rare diseases too often falls upon patients and their families.

22 Jul 2010

New carbon nanomaterial fights disease causing bacteria

A new form of paper with the built-in ability to fight disease-causing bacteria could have applications that range from anti-bacterial bandages to food packaging that keeps food fresher longer to shoes that ward off foot odor. A report about the new material, which consists of the thinnest possible sheets of carbon, appears in ACS Nano, a monthly journal.

22 Jul 2010

Fera acquires investigational new drug for treatment of fungal otitis externa

Fera Pharmaceuticals announces the acquisition of an investigational new drug to treat fungal otitis externa (FOE).

22 Jul 2010

Herbal dietary supplements may contain toxic metals

Millions of people are taking herbs and other plant-based dietary supplements to improve their health, but they have precious little information on the actual effectiveness or potential ill effects of these products. That's the topic of an article in the current issue of Chemical & Engineering News weekly newsmagazine.

22 Jul 2010

Elan total revenue increases 10% to $579.4 million for first half of 2010

Elan Corporation, plc today reported its second quarter and first half 2010 financial results.

22 Jul 2010

Smoking cessation effectively alter subgingival microbiome in patients on periodontal therapy: Study

Patients with chronic gum disease who quit smoking in addition to undergoing nonsurgical therapy not only demonstrated a lower abundance of harmful oral pathogens, but also an increase in health-associated bacteria. The researchers from The Ohio State University, Columbus Ohio, and Newcastle University, United Kingdom report their findings in the July 2010 issue of the Journal of Clinical Microbiology.

22 Jul 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010