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Synovis Life Technologies' Flow Coupler receives FDA marketing approval

Synovis Life Technologies, Inc., has received Food and Drug Administration 510(k) marketing clearance for its Flow Coupler®, an innovative extension of the company’s well-established Microvascular Anastomotic Coupler used in several surgical procedures to connect small blood vessels more quickly and with equal or greater reliability than hand suturing. The Flow Coupler incorporates Doppler technology to immediately measure blood flow after connecting the small blood vessels.

9 Feb 2010

Teva Pharmaceutical Industries extends marketing rights for laquinimod, includes Nordic and Baltic regions

Teva Pharmaceutical Industries Ltd. and Active Biotech announced today that they have amended the marketing and distribution agreement for oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Under the new agreement, Teva extended its marketing and distribution rights to include the Nordic and Baltic regions, previously held by Active Biotech. Active Biotech will receive a higher royalty rate for sales in these territories compared to the royalty rate set under the original licensing agreement signed in 2004 for sales in the rest of the world.

9 Feb 2010

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome.

8 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

Compulsive food seeking despite painful consequences

Ever get a buzz from eating chocolate? A study published in the open access journal BMC Neuroscience has shown that chocolate-craving mice are ready to tolerate electric shocks to get their fix.

8 Feb 2010

Self-love heals physical, emotional, mental and spiritual wounds

"Healing" has become a buzzword in American culture. But what exactly does it mean? In his new book, Healing (Hawk Press, 2010), healer David Elliott defines healing as "the journey back to our natural state of balance and harmony that is called love."

8 Feb 2010

Beer may help prevent osteoporosis

A new study suggests that beer is a significant source of dietary silicon, a key ingredient for increasing bone mineral density. Researchers from the Department of Food Science & Technology at the University of California, Davis studied commercial beer production to determine the relationship between beer production methods and the resulting silicon content, concluding that beer is a rich source of dietary silicon. Details of this study are available in the February issue of the Journal of the Science of Food and Agriculture, published by Wiley-Blackwell on behalf of the Society of Chemical Industry.

8 Feb 2010

Stronger animal disease traceability system will help minimize harm to other food animals, food producers and the public

In response to a statement by Agriculture Secretary Tom Vilsack today, the American Veterinary Medical Association (AVMA) is reaffirming its call for a strong, national animal disease traceability program to help maintain and improve the health of U.S. livestock.

6 Feb 2010

WFP has reached 600,000 Haitians with food voucher plan

On Thursday, a food distribution voucher campaign that launched last Sunday, "hit all 16 fixed distribution points around the capital" of Port-au-Prince, CNN reports. "So far, 600,000 people affected by the devastating January 12 earthquake have been able to collect food under this plan, said Marcus Prior, spokesman for the United Nations World Food Programme [WFP]. 'We're encouraged by the way the system is working to get food out into the city to those in need, but still have a long way to go,' Prior said" (Basu, 2/5).

6 Feb 2010

Haiti relief efforts: HFHN distributes $35M

"Hope for Haiti Now" (HFHN) today announced the distribution of $35M as the first installment of funds raised through the January 22nd telethon: "Hope for Haiti Now: A Global Benefit for Earthquake Relief." Six of the telethon beneficiaries (Oxfam America, Partners In Health, the American Red Cross, UNICEF, United Nations World Food Programme, and Yele Haiti Foundation) submitted proposals last week.

6 Feb 2010

EndoSheath Systems advantageous over germicidal immersion in preventing flexible ENT scope contamination

Results of a clinical study presented Thursday, Feb. 4 at the annual Triological Society meetings in Orlando, Fla., suggest a sterile barrier sheath system has distinct advantages over germicidal immersion processes used to prevent contamination of fiberoptic nasopharyngolaryngoscopes (flexible ENT scopes). Flexible ENT scopes are used by otolaryngologists to examine the nose and throat area for various disorders such as dysphagia, reflux disease, snoring, and chronic sinusitis.

6 Feb 2010

Artificial pancreas can help manage diabetes in kids overnight

In a landmark study in children and teenagers with type 1 diabetes, JDRF-funded researchers at the University of Cambridge showed that using a first-generation artificial pancreas system overnight can lower the risk of low blood sugar emergencies while sleeping, and at the same time improve diabetes control.

6 Feb 2010

$1.2B needed to aid women, children in 28 countries 'in crisis,' UNICEF says

UNICEF on Thursday launched a $1.2 billion appeal aimed at providing "life saving emergency assistance to millions of children and women in dire need," VOA News reports (Schlein, 2/4). "The appeal is part of UNICEF's Humanitarian Action Report 2010, released in Geneva ... which spotlights the desperate situation of children and women in 28 countries and territories facing deep humanitarian crises," the U.N. News Centre writes (2/4).

6 Feb 2010

Combination of Motrin and Robitussin drugs is safe for adults and children

A viral e-mail currently making the rounds between private accounts and public message boards warning of a danger posed by mixing over-the-counter medications Motrin and Robitussin is unfounded.

6 Feb 2010

Reliv International adds new products to its portfolio

Reliv International, Inc. introduced three new products to its Relivables line at the company's national conference here today. The products represent the first extension of the Relivables line since it was introduced last August.

6 Feb 2010

HHS donates more than $119 million to support health promotion initiatives

The U.S. Department of Health and Human Services (HHS) today awarded more than $119 million to states and U.S. territories to support public health efforts to reduce obesity, increase physical activity, improve nutrition, and decrease smoking-the four most important actions for combating chronic diseases and promoting health

6 Feb 2010

FDA's issues guidance on Bayesian statistical methods in medical device clinical trials

The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

6 Feb 2010

Local organizations team up to support Haiti's healthcare system

Injured Haitians desperately in need of medical treatment will soon have advanced technology available to the medical professionals providing their care. Through a partnership of Stamford Hospital, FUJIFILM Medical Systems USA (Fujifilm), and AmeriCares, a portable digital x-ray system is being donated to the Haitian relief effort and will be sent to a hospital where currently x-ray capabilities are simply non-existent.

6 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Solvay Pharmaceuticals, Inc. announced that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

5 Feb 2010