Pharmabiz
 

OTC version of Omeprazole approved in US

Dr. Venkat Appaji PadmanabhuniWednesday, October 15, 2003, 08:00 Hrs  [IST]

Procter & Gamble has launched its over the counter (OTC) version of blockbuster ulcer and heartburn drug Prilosec (omeprazole) in the US, potentially heralding radical changes in this valuable disease market. The US consumer and health products giant is marketing its OTC switch drug under license from AstraZeneca, which continues to sell the prescription version of Prilosec. Procter & Gamble expects a $100 million investment in marketing to be rewarded by sales of $200-400 million in the first year. US drugstores are selling Prilosec OTC at significantly less than a dollar a pill, representing a substantial saving over the cost of prescription Prilosec. Several large health insurers have announced that they will stop covering prescription Prilosec and its generic equivalents, in a bid to save costs by encouraging consumers to use the cheaper OTC alternative. Spheron discovery, an important breakthrough in quest for Alzheimer therapeutics Spherotoxins have been linked by new lines of evidence to some of the major underlying brain cell death in Alzheimer's disease. Spherotoxins are said to represent in many ways a much more promising approach for an effective Alzheimer's disease drug than other well-known drug development targets such as amyloid beta protein. Currently, there are no treatments for Alzheimer's disease which can modify the basic progressive fatal nature of the disease. New approaches linked to the underlying pathology of Alzheimer's disease are critically needed. According to Nymox's research scientists, spherotoxin molecules are released by bursting spherons in the aging brain, contributing significantly to the cell death and symptoms characteristic of Alzheimer's. Spherons are dense aggregates of protein found in the brains of everyone from age one. Researchers have found that as we grow older, spherons enlarge until they can no longer be contained in their brain cells. They eventually burst, creating senile plaques and setting off cellular damage and biochemical changes that are instrumental to the symptoms of Alzheimer's disease. Vaccine for Pancreatic cancer Pancreatic cancer has the highest mortality rate of all tumors, with less than 3 per cent of those diagnosed surviving for more than five years Scientists at ECCO (European Conference on Clinical Oncology) meeting in Copenhagen have presented research on a new vaccine for the treatment of pancreatic cancer using proteins from the patient's own tumor. Although preliminary results appear encouraging, it will be some time before patients can gain access to the drug. The high mortality rate from pancreatic tumor is the result of the tumor spreading rapidly to distant sites prior to the patient developing symptomatic disease. The pancreatic cancer vaccine is personalized to each patient by using a heat shock protein (HSP) that helps cells recover following adverse events. As cancer cells over-express this specific HSP, the vaccine can stimulate the immune system into attacking the tumor itself. Australia tackles ageing with health foods New ways to detect and prevent bowel cancer, heart disease, Parkinson's and Alzheimer's diseases will be investigated by CSIRO's Preventative Health National Research Flagship (P-Health), Australia. The programme will develop new foods and diets which combat disease and promote well-being and also use genes and proteins to predict and prevent ill-health. The researchers are also to investigate new ways to identify disease before it becomes serious and develop easy ways to help people better manage their health. "We will promote the objectives of 'wellness' and disease prevention and develop a range of measures - from foods and diets to early-stage diagnosis and improved management of disease - to assist healthcare professionals and individuals to reduce the incidence and severity of ill-health," an official of CSIRO said. The P-Health Flagship will bring together genomics and proteomics, nanotechnology and biotechnology, information technology, data mining, biodiscovery of new treatments, psychology and nutritional science. Ginseng warning for pregnant women One of the active chemicals in ginseng - ginsenoside Rb1 - is associated with significant development defects in animal embryos, report Hong Kong researchers in issue of the journal Human Reproduction. Ginseng is taken to enhance stamina and reduce feelings of fatigue and physical stress. It is also believed to have an anti-cancer function and has recently been found to normalise blood glucose levels, improving insulin sensitivity and reducing risk of obesity. However much less is known about the potential toxicity of the herbal and there are no data about its potential effect on the developing human foetus. Ginsenoside Rb1 is only one of the ginsenosides in commercially available ginseng. More than 20 have been identified and previous studies have shown that different ginsenosides might have different actions. Further studies are needed to evaluate the potential teratogenic effects of other ginsenosides, said the researchers. "Before more information in humans becomes available, women should be cautious about using ginseng in the first three months of pregnancy and it is always advisable for pregnant women to consult their doctor before taking any herbal supplement," continued the researcher. India is 2nd largest in mail imported prescription drugs in US Nine out of 10 prescription drugs mailed from outside the U.S. may be unsafe, the FDA says. The federal agency -- in cooperation with the U.S. Customs & Border Protection agency-- opened hundreds of packages at international mail facilities in Miami, New York, San Francisco, and Carson, Calif. They were looking for prescription drugs ordered from outside the U.S. They came up with more than 1,000 imported drug products. The vast majority - 88 per cent -- were unapproved by the FDA. That means they may be unsafe, says Thomas McGinnis, PharmD, FDA director of pharmacy affairs. FDA labs are still testing the confiscated drugs to see what they contained. But even if they are what they're supposed to be, McGinnis says, they still pose safety problems. The biggest drug exporters were based in Canada (16 per cent), India (14 per cent), Thailand (14 per cent), and the Philippines (8 per cent). But they also came from a wide range of other nations as nearby as Mexico and as far off as Malaysia. "The FDA does not go after consumers at all," McGinnis says. "We go after commercial entities, whether they are advertising, marketing, or distributing unapproved drugs or whether they are some kind of facilitator, like these storefront operations that mail your prescription to the overseas pharmacy and charge your credit card." Why are Americans importing so many prescription drugs? Price, of course, the official says. Some of the drugs confiscated by the FDA were ordered in Canada, but shipped from India -- bearing labels in an Asian language.

 
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