|
|
 |
 |
 |
|
 |
|
|
|
|
|
| | WASHINGTON (Reuters) - U.S. health regulators have finalized new warnings for controversial inhaled asthma drugs, but exercised new powers to order the changes on products made by GlaxoSmithKline Plc and AstraZeneca Plc
Susan Heavey
The warnings, expected since February, say medicines known as long-acting beta-agonists, or LABAs, should never be used on their own to treat asthma, Food and Drug Administration officials said on Wednesday. While some of the companies accepted the changes, the two British drugmakers resisted, agency officials said.
Glaxo's Serevent and Novartis AG's Foradil, which Merck & Co Inc markets in the United States, are LABA drugs. Two more widely used blockbuster medicines -- Glaxo's Advair and AstraZeneca's Symbicort -- are combination drugs that include a LABA with a corticosteroid.
Letters announcing the final label warning were also sent to Sepracor Inc, now part of Dainippon Sumitomo Pharma Co and the maker of Brovana, and Dey Pharma, a subsidiary of Mylan Inc that makes Perforomist, the FDA said.
"FDA is ordering the involved companies to make labeling changes capturing these new recommendations,Dr. Badrul Chowdhury, head of the FDA's pulmonary drugs division, told Reuters. Note all of the companies have accepted all the changes ... so that's where the ordering comes in. | |  | |
| | | |
| | CHICAGO (Reuters) - A highly sensitive blood test may be able to predict whether prostate cancer is cured or is likely to come back, giving doctors an early sign of whether treatments are working, U.S. researchers said Wednesday.
Xavier Briand They said the nanotechnology-based blood test is far more sensitive than currently available commercial tests for prostate-specific antigen, or PSA, a protein produced by cells in the prostate gland.
"Our assay can detect PSA in blood samples 300 times better than the current standard PSA tests," Dr. Shad Thaxton of Northwestern University's Feinberg School of Medicine in Chicago said in a telephone interview.
The test is not intended for routine prostate cancer screening, but is meant to look for signs that prostate cancer has spread to other organs in patients who have had their prostate gland removed.
Through the technology, it appears we will be better at determining which patients are cured and which patients are destined for prostate cancer recurrence," said Thaxton, whose study was presented at the American Urological Association meeting in San Francisco.
It may allow physicians to act at the earliest and most sensitive time, which we know will provide the patient with the best chance of long-term surviva he said.
The new test takes advantage of some special properties of gold nanoparticles -- which are 1,000 to 100,000 times smaller than the width of a human hair.
Gold nanoparticles have the ability to act as catalysts, and they interact very intensely in light," Thaxton said.
To make a blood test, the team added antibodies onto the surface of the gold particles, which seek out and stick to tiny bits of PSA in the blood.
Men who have had the prostate removed because of cancer should have only trace amounts of PSA in their blood. But if a prostate tumor has spread to other organs, it may be producing PSA. That is what the new test is looking for, Thaxton said.
The team studied the test using frozen blood taken from men after prostate surgery whose blood had tested clean for PSA using standard tests.
The new test showed that low or steady PSA levels meant that the prostate cancer was gone 10 years later. But in men whose PSA level was higher than expected, prostate cancer was more likely to come back.
The next step would be a clinical trial comparing the new test to traditional PSA tests to see if earlier detection can save lives.
The test, known as VeriSens PSA, is currently available for research use only from privately held Nanosphere Inc of Northbrook, Illinois.
| | | |
| | | |
| | WASHINGTON (Reuters) - Low doses of GlaxoSmithKline's diabetes drug Avandia combined with metformin can prevent diabetes without causing the most common side-effects, Canadian doctors reported on Wednesday.
Eric Walsh
Taking half a dose of Glaxo's combination pill reduced by two-thirds the risk that patients would go from having high blood sugar -- pre-diabetes -- to full type-2 diabetes, the researchers reported in the Lancet medical journal.
Fourteen percent of the patients treated with the drugs developed diabetes after four years, compared to 39 percent of those given placebo, the researchers found.
The effect would likely be the same with Avandia's rival drug in the same class, Takeda's Actos, said Dr. Bernard Zinman of Mount Sinai Hospital at the University of Toronto, who led the study.
"I think it is a class effect," Zinman said in a telephone interview.
Actos, known generically as pioglitazone and Avandia, known generically as rosiglitazone, belong to a class of drugs called thiazolidinediones, which help the body better use insulin.
Type-2 diabetes is caused as the body gradually loses its ability to respond to insulin, a condition called insulin resistance. Overeating,a lack of exercise, genes and other factors all play a role.
As insulin works less and less well, levels of glucose rise in the blood, damaging blood vessels and organs. The beta cells in the pancreas begins to lose their ability to make insulin. | | | |
| | | |
|
|
|
