- (
) Alli and the weight loss drug market
The doors could be wide open for additional growth of the only FDA-approved over-the-counter product in light of the general underachievement of the weight loss drug category. However, one of the major obstacles standing in its way are dietary supplements, which currently snatch up some of alli's potential market share. GlaxoSmithKline's (GSK) recent petition to the US Food and Drug Administration (FDA), which requests all weight loss claims be considered drug claims, could eliminate this competition.As part of a series on the GSK petition and its impact on the US dietary supplements industry, NutraIngredients-USA.com here examines the state of the market for weight loss drugs.Underachievement for drugsAccording to a report published yesterday by Edison Investment Research, an equity research firm, the market for weight loss drugs has until now been stunted because of the side effects or limited efficacy of most products."Although prescription pharmaceuticals for treating obesity have been available for most of the 20th century, their development has been beset with problems. More>>
- (
) Unexpected events don't faze El Paso challenge participants
Central El Paso resident Isabel Castillo said participating in the second GECU Savings Challenge has given her peace of mind. Castillo woke up with a start about 3:30 a.m. April 13 to find that a driver who had fallen asleep behind the wheel had hit her pickup, which was parked in front of her home.
She said she was in shock to see her recently paid-off truck totaled, but she was calm inside.
"When the police officer asked me for my insurance, I realized everything was OK," she said. "I had my things in order. When I thought about my deductible being $1,000, if I wasn't in the Savings Challenge, I wouldn't have had that money in my savings."
Castillo, who is single, is one of six sets of participants in GECU's second edition of its Savings Challenge program. She works as an executive assistant at Channel 4-KDBC (cable Channel 3) and owns One Take VO, which does voice-overs and translations and creates scripts for advertisements. More>>
- (
) Busy Hurricane Season Predicted
With weather forecasters calling for an above average hurricane season, Fresenius Medical Care North America, operator of the nation's leading network of dialysis clinics, is urging all kidney failure patients to plan for a hurricane or other disaster.
About 26 million people in the United States have kidney disease, according to the National Kidney Foundation, and more than 360,000 of them are on dialysis. These patients represent one of the most vulnerable segments of the population during a natural disaster. They typically need dialysis every two days; when storms disrupt electrical power or make routine travel to treatments impractical, any substantial delay in dialysis care can be life-threatening.
"People on dialysis need it to live. With hurricane season approaching, this is a good time to make sure they have backup plans in case a disaster strikes," said Bill Numbers, Vice President of Operations Support and Incident Commander for Disaster Response and Planning at Fresenius Medical Care. More>>
- (
) FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.
"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food," said Margaret O'K. More>>
- (
) Adalimumab shows long-term remission in Crohn's patients: Abbott
Results from an open-label extension study of two Abbott pivotal studies, Charm and Gain, demonstrate that adult moderate-to-severe Crohn's patients treated with Humira (adalimumab) achieved long-term clinical remission and clinical response, respectively, according to data presentations at Digestive Disease Week (DDW) in San Diego.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Patients from Charm and Gain were followed through into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients from Charm were followed a total of two years, and patients from the 4-week Gain study were followed a total of one year.
The Charm extension data demonstrated that three out of four patients (77 percent) taking Humira, who were in remission at the end of the one-year pivotal study, maintained clinical remission for an additional year. More>>