Latest News For 'Generic Pharmacy'
July 5th, 2007
Gene therapy using nerve growth factors reversed erectile dysfunction in rats within four weeks, say University of Pittsburgh School of Medicine researchers.The Pittsburgh team found that the genes for the “glial cell line derived neurotrophic factor” (GDNF) and the GDNF family ligand, called neurturin, were both effective in treating erectile dysfunction in the rats. The genes were placed in a genetically engineered herpes simplex virus, which was then injected into the rats’ damaged cavernous nerve.
The finding suggests a potential new treatment for ED in men.
“Because the herpes virus persists in the nerve cell for as long as it is alive and nerve cells typically do not reproduce, this represents the first-ever demonstration of a long-term treatment for ED that does not rely on the chronic administration of drugs that can have potentially harmful side effects,” study co-leader Joseph C. Glorioso, chairman of the department of biochemistry and molecular genetics, said in a prepared statement.
The study was to be presented over the weekend at the annual meeting of the American Society of Gene Therapy, in Seattle.
July 4th, 2007
I don’t know about you, but I hope all the Armani-clad zillion-dollar-a-year health-care CEOs are squirming in their $1,000 leather office chairs while Michael Moore’s “Sicko” hits theater screens this week. I haven’t seen Moore’s film about our much-flawed health-care system yet, but I, for one, believe it’s way overdue.
Like any industry, the health-care business is all about the Benjamins. In a moment, I will offer my simple prescription for taking America’s sicko health-care system off life support.
If I sound a little peeved at our lack of affordable, available health care, I am. In the spirit of full disclosure, I’ll share a couple personal examples of why I believe Moore needed to make this film.
Just recently, my monthly co-pay for the cholesterol-fighting drug Lipitor increased by 150 percent. I don’t care whose fault that is. One hundred fifty percent increases are criminal. Within seconds, I was on the phone to my primary care physician. He prescribed Simvastatin, the generic replacement i.e. Generic Viagra for the Pfizer pill. My co-pay returned to $10. I guess I shouldn’t be surprised at the meteoric rise in prescription costs. Moore’s film claims there are four health-care industry lobbyists for every member of Congress. Somebody has to feed their babies.
This next example is even better. Early last year, I had to pay $5,000 cash up front for a surgical procedure, since the surgeon I elected to use was out of my health-care network. In fact, he doesn’t even accept managed care plans. But, since he’s the top guy in his field, I felt the investment was worth it, knowing I was entitled to a partial reimbursement from my health-care provider afterward.
Weeks after the operation, I submitted a request for reimbursement, using the specified forms provided. I waited. And waited. And waited. Nothing.
Just so happens, I have a friend whose job is dealing with insurance payments for her doctor’s office. She offered to look into why I wasn’t receiving some money back. She knew how to navigate the system, which buttons to push. She knew who to ask for. Nearly a year after filing my original claim, a check for $1,400 showed up in my mailbox. Without my friend, I’d be just another American getting ripped off because of an insurance system that is convoluted and, in my opinion, deliberately burdensome.
Memo to those looking for a new career: Become a billing advocate for those of us hopelessly confused by today’s insurance procedures. You’ll make a fortune.
In all fairness to the “system,” we consumers need to take accountability by staying healthy. The fix? Eat well. Exercise. Doctors, how about taking down those clocks and posters in your office sponsored by the drug companies? They’re insulting to hard-working Americans. Can you replace your Viagra wall clock with one sponsored by the broccoli growers industry instead? Throw out your Ambien pens, and use pens from the American Heart Association.
source: http://www.nashuatelegraph.com
July 4th, 2007
The first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin underneath the nail.
Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy’s Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.
The remaining patent or exclusivity for Lamisil expired on June 30, 2007.
According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.
In addition to terbinafine tablets, there is a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete’s foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.
July 3rd, 2007
An old ulcer operation is getting new attention as a possible alternative obesity surgery: a quick snip of a nerve that helps control hunger.
It’s far from clear if cutting the vagus nerve really helps _ initial pilot studies in a few dozen patients have just begun. Skeptics abound, and even proponents say it wouldn’t lead to nearly as much weight loss as more traumatic operations that shrink the stomach and reroute intestines.
It’s part of a hunt for middle-ground options for people scared of today’s surgery, or those not quite fat enough to qualify for it.
“By no means do I think this is a panacea,” cautions Dr. Robert Lustig of the University of California, San Francisco, who is studying the method along with University of Rochester surgeons.
“But I think this will be a rational alternative for a cadre of patients that are sort of in the middle there. With as much obesity as we have in this country, that’s a big middle.”
More than 177,000 people underwent obesity surgery last year, according to the American Society for Metabolic and Bariatric Surgery. The most popular method is gastric bypass, stapling the stomach to create a tiny pouch. Options include placing an adjustable band around the stomach, or cutting off the stomach’s side and rerouting the intestines.
Surgery can produce life-altering weight loss, if recipients adhere to diet and exercise advice, but each method comes with varying degrees of pain and risk, including a rare chance of death. So doctors are searching for alternatives.
Enter the vagus nerve, which snakes from the brain to the abdomen, with fibers reaching into multiple organs with different effects. Among them: The nerve spurs gastric acid production, and in the 1970s, surgery to cut where it attaches to the front and back of the stomach brought ulcer sufferers great relief _ after they recovered from open-abdominal surgery. Once better acid-reducing medications came along, this arduous operation was abandoned.
Yet surgeons at the time noticed, and subsequent animal studies confirmed, that these vagotomies could trigger weight loss. In addition to a less acidic stomach’s slower digestion, the vagus helps control appetite-stimulating brain hormones and signals our bodies to store more fat, Lustig explains.
Since doctors today can snip the nerve far less invasively, through just five pencil-sized cuts in the abdomen, it was time to test in the obese.
Thirty patients had a vagus snip at UCSF or the University of Rochester. The study isn’t complete. But of the 11 who are a year past surgery, all but one are shedding pounds, losing an average of 18 percent of excess weight so far, Lustig and Rochester’s Dr. Thad Boss reported at last month’s bariatric society meeting.
They suffered no serious side effects, and went home hours later with little pain.
“Every patient who had the vagus nerve cut says they’re not hungry,” adds Lustig _ although the one who didn’t respond got hungry again six weeks after surgery, perhaps because the nerve healed.
That’s less than half the weight loss of standard surgeries, warns Dr. Neil Hutcher of Bon Secour St. Mary’s Hospital in Richmond, Va., and a past president of the bariatric society.
“I have my doubts that vagotomy alone is going to be a significant weapon,” says Hutcher, who often cuts the nerve during standard gastric bypasses for a different reason _ to help those patients avoid the side effect of heartburn-causing acid buildup.
But, when Greensboro, N.C., surgeons added a vagotomy to 25 patients getting bands on their stomachs, the nerve-snip seemed to make that usually more modest operation about as effective as a gastric bypass _ with 43 percent loss of excess weight at six months, and counting.
For a more rigorous study, Rochester’s Boss is about to recruit 60 more patients headed for band surgery, giving half a vagotomy as well.
The pilot studies were funded by a startup medical device company called EndoVx Inc. that hopes one day to further simplify vagotomies, cutting the nerve by beaming high-intensity ultrasound waves down the throat.
Other doctors are testing if implants that treat epilepsy by stimulating the vagus nerve also might trigger weight loss, with mixed results so far.
For now, Boss stresses that vagus nerve-snipping remains highly experimental. He and Lustig will track their 30 patients for 18 months to check if ultimate weight loss is enough to warrant further study, and who responds best.
The goal is to help people like Garth Michaels of Walnut Creek, Calif., who twice backed out of standard obesity surgery, fearful of side effects and a long recovery. Thirteen months after he volunteered for the vagotomy experiment, he has dropped 66 pounds, to 246.
That’s a much more gradual loss than with regular surgery, but Michaels says having his hunger curbed help him finally learn to exercise. He spends a half-hour on an exercise bike most days. And he learned to avoid former diet saboteurs _ french fries, sweets _ that caused foul burping after his vagotomy, in favor of fruits and vegetables.
“I will lose more, there’s no doubt about it,” says Michaels, 56, whose goal is 175 pounds. “It has given me such hope.”
July 2nd, 2007
Can an antipsychotic drug from the 1950s be paired with a 1980s antibiotic to shrink 21st-century tumors? Might an anticlotting drug help a steroid relieve arthritis? How about a cholesterol treatment and a pain reliever teaming up to tame diabetes?
Alexis Borisy, the pharmaceutical industry’s master matchmaker, is betting they can. And if he is right, he may have found a cheap and quick way to develop a new cornucopia of medicines.
Borisy is the 35-year-old co-founder and chief executive of CombinatoRx, a biotechnology company dedicated to the proposition that two old generic drugs can together make a powerful new medicine, often for an entirely different disease.
It is too early to tell if Borisy will succeed and, indeed, one of his company’s drugs failed in a clinical trial last week.
But with drug makers big and small struggling to fill their product pipelines, other biotechnology companies are also betting that pairing old drugs can be a better business than inventing new ones from scratch - which can take years and cost hundreds of millions of dollars, with no guarantee of success.
For example, Pozen, based in Chapel Hill, North Carolina, is developing combination drugs in partnerships with the pharmaceutical giants GlaxoSmithKline and AstraZeneca.
Orexigen Therapeutics of San Diego, recently went public based on the prospects for two combination drugs it is developing to treat obesity. And privately held Celator Pharmaceuticals of Princeton, New Jersey, has raised more than $40 million from venture capitalists to combine old cancer drugs in a new way.
“We think if we prove this concept clinically we have an almost unlimited pipeline,” said Andrew Janoff, the chief executive of Celator.
Helping propel the trend is the growing supply of drugs that have lost patent protection, providing a lode of material to test for newfound potential.
Information technology also plays a key role for CombinatoRx (which is pronounced com-bin-a-TOR-ics, as in the mathematics field that deals with combinations). The company relies on the latest robotic drug-screening technology and software to test several thousand pairs of medicines a day.
At its laboratory here, researchers and robots systematically pair about 2,000 generic drugs with one another, with two million different combinations possible.
Each is tested on human cells. If a drug pair inhibits the cells’ production of inflammatory proteins, for example, that might be reason to explore whether the combination might work against arthritis.
Borisy describes it as a “dumb, brute-force, empirical approach” that assumes current knowledge of disease is too limited to predict in advance what combinations might work. The company does, though, give priority to testing pairs it believes have the best chance of working.
Eight of the company’s randomly arranged marriages, including drugs for cancer, arthritis and diabetes, have moved into clinical trials - an unusually high number for a company that is only seven years old.
Besides being quicker or cheaper to develop than single new drugs, combinations might also be more effective. Doctors routinely use two or more drugs to treat people with cancer, heart disease, HIV infection and other diseases.
But only more recently have pharmaceutical companies decided to do the combination themselves as a way to increase their profit.
Successful combination drugs already on the market include Advair from GlaxoSmithKline, which pairs two asthma drugs, and Vytorin, which combines cholesterol-lowering drugs from Merck and Schering-Plough that work in different ways.
July 2nd, 2007
All veterinary products like generic drugs must be registered with the Health Ministry by the end of the month. Health Minister Datuk Seri Dr Chua Soi Lek said on Saturday it was to ensure that these products were safe for the use by farmers and those in the rearing industry. He said Beta Agonis, for example - which was banned in animal feeds - was still being used by pig farmers in the country. He said the drug was also found to have side effects on human being. “It is time that we make it compulsory for manufacturers and importers to register their products to help us to monitor and control the use of the drugs,” he said. Dr Chua said currently veterinary products need not be registered with the ministry. Dr Chua said the regulation applied to products manufactured locally and imported ones.
He said through the process, they could ensure that the veterinary products were of quality, effective and safe for use by farmers.
Dr Chua said manufacturers and importers of such products could register on-line with the Drugs Control Division of the ministry.
Source:- http://thestar.com.my/news/story.asp
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