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LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

Gamida Cell-Teva Joint Venture's StemEx program receives FDA Fast Track Designation

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.

21 Jun 2010

FDA grants EarlySense marketing clearance for EverOn Touch system

EarlySense announced today that its EverOn Touch system has been cleared for marketing by the U.S. Food and Drug Administration. The FDA clearance covers several key additions to the traditional EverOn contact-free patient supervision system value proposition. For the first time, the EverOn system includes an online display that alerts medical staff regarding a patient's motion level and verifies patient turns as indicated by nurses. Identifying low patient movement and then turning patients methodically are key elements in the prevention of pressure ulcers, the most costly patient safety risk in U.S. hospitals.

21 Jun 2010

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. announced guidance today regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed study's design, timing and regulatory review.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

OncoGenex Pharmaceuticals, Inc. announced today the initiation of a Phase 3 registration trial of custirsen sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC). This trial, referred to as the Prostate Cancer SATURN Trial, is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries to develop and commercialize OGX-011/ TV-1011.

21 Jun 2010

FDA accepts ev3's Pipeline Embolization Device PMA for expedited review

ev3 Inc., a global endovascular device company, today announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the Pipeline Embolization Device for treatment of large, giant and wide-necked cerebral aneurysms. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is May 18, 2010, the date the FDA received ev3's PMA submission.

21 Jun 2010

Spark Together for Health Kids program promotes access to physical activity, healthy food

A new survey by the Heart and Stroke Foundation of Ontario found the majority of kids in the Greater Toronto Area (GTA) will be missing out on physical activity this summer, as parents scramble to find child care solutions once school is out.

21 Jun 2010

New tobacco regulations and FDA rules authorized by Family Smoking and Prevention Act to be released

Starting tomorrow (June 22), new regulations and FDA rules authorized by the Family Smoking and Prevention Act will further limit the tobacco industry's ability to deceive consumers with misleading marketing and labeling that imply "light," "mild" or "low-tar" cigarettes are safer, as well as other practices that make products more appealing to youth.

21 Jun 2010

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam, which is marketed by Bristol-Myers Squibb.

21 Jun 2010

Exelixis announces regaining of rights to develop and commercialize XL184

Exelixis, Inc. today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials.

21 Jun 2010

Picking right soundtrack could improve getting a date, suggest French researchers

If you're having trouble getting a date, French researchers suggest that picking the right soundtrack could improve the odds. Women were more prepared to give their number to an 'average' young man after listening to romantic background music, according to research that appears today in the journal Psychology of Music, published by SAGE.

21 Jun 2010

Magic Power Coffee can dangerously lower blood pressure, warns FDA

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

21 Jun 2010

American Heart Association CEO on first anniversary of Family Smoking Prevention and Tobacco Control Act

The one-year anniversary of the Family Smoking Prevention and Tobacco Control Act brings new consumer protections that will make it increasingly difficult for the tobacco industry to recruit the next Marlboro man, woman or child. With many important provisions already in effect, we can celebrate the lives we have saved with rules restricting Big Tobacco's deceptive marketing practices, particularly towards children.

19 Jun 2010

Medtronic's anatomically-designed ablation catheters reduce lab time for PVI

Data from the FAST-PVI study, supported by Medtronic, Inc., shows lab time using anatomically-designed ablation catheters are more than one-third (35 percent) faster than traditional point-by-point focal ablation procedures in achieving pulmonary vein isolation (PVI). PVI is the cornerstone catheter procedure to treat paroxysmal atrial fibrillation (PAF).

19 Jun 2010

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

19 Jun 2010

Report examines G8's $22B food security pledge, highlights need for funding delivery

A report from the anti-poverty group ActionAid finds that less than one-third of the $22 billion that was pledged to improve food security during a 2009 G8 meeting in L'Aquila, Italy, is from new funding sources, the U.K. Press Association reports (6/18).

19 Jun 2010

ARS research physiologist develops preliminary model that predicts individual's vitamin D requirements

Your skin tone and the amount of sunshine you receive--in addition to what foods you eat--all can influence the amount of vitamin D that your body has on hand for optimum health. In a preliminary and apparently first-of-its-kind study, Agricultural Research Service research physiologist Charles B. Stephensen and colleagues have developed a preliminary model that predicts an individual's vitamin D requirements.

19 Jun 2010

Phase III clinical trial data of Cayston versus TIS in CF patients with P. aeruginosa presented at ECFC 2010

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) percent predicted after 28 days of treatment.

19 Jun 2010

Food News and Research

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Gamida Cell-Teva Joint Venture's StemEx program receives FDA Fast Track Designation

FDA grants EarlySense marketing clearance for EverOn Touch system

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

FDA accepts ev3's Pipeline Embolization Device PMA for expedited review

Spark Together for Health Kids program promotes access to physical activity, healthy food

New tobacco regulations and FDA rules authorized by Family Smoking and Prevention Act to be released

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

Exelixis announces regaining of rights to develop and commercialize XL184

Picking right soundtrack could improve getting a date, suggest French researchers

Magic Power Coffee can dangerously lower blood pressure, warns FDA

American Heart Association CEO on first anniversary of Family Smoking Prevention and Tobacco Control Act

Medtronic's anatomically-designed ablation catheters reduce lab time for PVI

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

Report examines G8's $22B food security pledge, highlights need for funding delivery

ARS research physiologist develops preliminary model that predicts individual's vitamin D requirements

Phase III clinical trial data of Cayston versus TIS in CF patients with P. aeruginosa presented at ECFC 2010

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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