The latest in Food and Drug Administration

FDA seeks more data on MannKind's inhaled insulin

2010-03-16T00:15:14Z

<div><p>BOSTON (Reuters) - U.S. regulators have requested more information on an inhaled insulin device being developed by MannKind Corp, sending the company's shares down 24.7 percent.</p><p>MannKind said on Monday that it had received a so-called complete response letter from t...

Boston Scientific suspends defibrillator sales

2010-03-15T16:30:12Z

<div><p>Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the best-selling devices.</p><p>The company said it uncovered two production changes that were not cleared with the ATLANTA (Reuters) - Adding a drug that lowers blood fats known as triglycerides to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study.</p><p>The study run by the Medtronic to drug therapy over at least one year in 245 patients in the Amylin Pharmaceuticals shares rise on FDA response for once-weekly diabetes drug</div><div><p>Shares of Amylin Pharmaceuticals jumped 13 percent Monday as the Food and Drug Administration asked for more information on its potential diabetes treatment.</p><p>Amylin, along...

BioSante cancer vaccine gets 'orphan drug' status

2010-03-15T10:00:21Z

<div id="subtitle">FDA gives BioSante pancreatic cancer treatment 'orphan drug' designation</div><div><p>BioSante Pharmaceuticals has received orphan drug status for its potential pancreatic cancer treatment, the company said Monday.</p><p>The company said the Food and Drug Administration<...

Cryogenic balloon offers hope to heart patients

2010-03-15T08:15:51Z

<div><p>An experimental ablation therapy system that freezes heart tissue with a balloon catheter to treat a common heart rhythm disorder is far more effective than drug therapy, a study found Monday.</p><p>Researchers compared the safety and efficacy of the Arctic Front CryoAblation Catheter System produced by US firm Medtronic to drug therapy over at least one year in 245 patients in the FDA) announced Friday it would reexamine its policy that bans gay men from donating blood</div><div><p> <p>The Food & Drug Administration (FDA) announced Friday it would reexamine its policy that bans gay men from donating blood, the 'Los Angeles Times...

Hair Restoration Methods

2010-03-15T13:46:54Z

If you are losing your hair, regardless of whether it is just starting to thin or if you are developing bald patches, there are hair restoration methods that can help. Although there are a number of different methods for restoring hair, surgical methods are often the most effective. Of course, the method will depend on individual circumstances, as well as the amount of hair that has been lost, but most people find that surgical hair restoration is a lasting and reliable solution to the proble...

FDA asks for risk plan info on diabetes drug

2010-03-15T04:00:20Z

<div id="subtitle">FDA asks Amylin and partners for risk plan, manufacturing information on diabetes drug</div><div><p>Amylin Pharmaceuticals Inc. said Monday it received a Food and Drug Administration request for information on manufacturing and a risk mitigation plan for a potential once-weekly diab...

No heart benefit seen with fibrates in diabetics

2010-03-14T14:15:32Z

<div><p>ATLANTA (Reuters) - Adding a triglyceride-lowering drug to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study.</p><p>The study run by the Plavix anti-blood clotting agent to add a boxed warning to its packets saying the drug may be less effective in preventing heart attacks in people who cannot metabolize it properly.</p><p>The new boxed warning ordered by the Food and Drug Administration is a further step up from jus...

Salmonella Recall Spreads Quickly to Other Products

2010-03-13T00:15:40Z

<div id="subtitle">Tainted spices and ingredients used in large number of food products</div><div><p>If you doubt how interconnected the food industry is, just look at what happens when a tainted ingredient enters the supply chain.</p><p>In January a meat processor recalled a large quantity of Italian meats because of suspected Salmonella contamination. From the start, however, inspectors believed the source was not the meat itself, but an ingredient or season...

Feds Probe Reports of Dog Deaths, Illnesses From Pork Bone Treats

2010-03-13T00:15:35Z

<div id="subtitle">Missouri company says it is "proud" of its products, refuses to compensate pet owners</div><div><p>A Missouri pet products company is under investigation by the Food and Drug Administration (FDA) amid reports that scores of dogs have became seriously ill or died after eating the manufacturer’s treats. The company at the...

FDA warning: some patients cannot process Plavix

2010-03-12T16:01:12Z

<div id="subtitle">FDA puts black box warning on Plavix, says certain patients can't process blood thinner</div><div><p>The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner.</p><p>The FDA said in a statement Friday th...

US orders new warning of limited Plavix effectiveness

2010-03-12T15:15:29Z

<div><p>US health officials Friday ordered the makers of the Plavix anti-blood clotting agent to add a boxed warning to its packets saying the drug may be less effective in preventing heart attacks in people who cannot metabolize it properly.</p><p>The new boxed warning ordered by the Food and Drug Administration is a further step up from jus...

Business Highlights

2010-03-12T15:01:15Z

<div><p>Retail sales show surprising gain in February</p><p>WASHINGTON (AP) — Retail sales posted a surprising increase in February as consumers refused to let snowstorms stop them from stepping up purchases for everything from clothes to appliances. The improvement provided hope that the recovery from the Great Recession is gaining momentum.</p><p>Some economists cautioned that spending increases will remain modest as long as wages stay flat and job creation ...

Summary Box: FDA puts black box warning on Plavix

2010-03-12T12:30:25Z

<div id="subtitle">Summary Box: FDA warns that some patients cannot process blood thinner Plavix</div><div><p>PLAVIX PROBLEM: The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner.</p><p>GENETIC CAUSE: A small percenta...

Eisai says FDA approved new Dacogen dosing

2010-03-12T04:15:12Z

<div id="subtitle">Eisai says 5-day bone marrow disease drug treatment approved; 3-day regimen approved in 2006</div><div><p>Drugmaker Eisai Inc. said the Food and Drug Administration approved a new, longer dosing regimen of its bone marrow disease treatment Dacogen.</p><p...

Vermont Court Holds R.J. Reynolds Accountable for Misleading Ads

2010-03-12T00:15:24Z

<div id="subtitle">Eclipse cigarette claims held deceptive and misleading</div><div><p>Big Tobacco suffered a big loss as Vermont Superior Court Judge Dennis Pearson found that R.J. Reynolds Tobacco Company’s advertising claims of a “reduced risk” cigarette were deceptive and misleading, in violation of Vermont’s Consumer Fraud Act and a 1998 set...