Showing posts with label rosiglitazone. Show all posts
Showing posts with label rosiglitazone. Show all posts
Monday, September 06, 2010
Thursday, August 12, 2010
Thursday, June 24, 2010
LOLPharma contd. ...
Nissen on patient enrollment in TIDE: "500 patients in 14 months. To get 16,000 patients will take another 448 months."
Monday, May 10, 2010
GSK - Avandia: 700 suits settled for $60 million
May 10 (Bloomberg) -- GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say.
Glaxo, the U.K.’s biggest drugmaker, agreed to resolve more than 700 Avandia suits filed by three attorneys, including Houston-based plaintiffs’ lawyer Mark Lanier and Philadelphia- based litigator Sol Weiss, the people said. The settlements come as Glaxo is set to face its first Avandia trial in state court in Philadelphia in July. The company faces about 4,000 lawsuits that have been filed so far over the drug.
“Settlement of litigation tends to be seen positively by the market because it’s minimizing risk,” Michael Leacock, an analyst at Royal Bank of Scotland Group Plc, said by phone from London today. “This all seems quite manageable.”
Mary Anne Rhyne, a U.S. spokeswoman for London-based Glaxo, said she couldn’t immediately comment on the Avandia settlements today.
Regulators approved Avandia for sale in the U.S. in 1999 and the medicine tallied annual revenue of $3 billion by 2006, including sales of a combination of Avandia and another drug.
Avandia sales plunged after a May 2007 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks, prompting U.S. and European regulators to order Glaxo to strengthen its warnings. Avandia was the world’s best-selling diabetes pill before safety concerns emerged.
Legal Reserves
Last month, Glaxo officials reported first-quarter profit that beat analysts’ estimates. They also noted the reserves budgeted for legal matters for the quarter increased by 210 million pounds ($311.8 million) because of “the progress we are making toward settlement of existing cases,” according to a April 28 statement.
Gbola Amusa, an analyst at UBS AG in London, said in March Glaxo faces as much as $6 billion in liability on Avandia and there’s a risk that U.S. regulators may force the company to take the drug off the market.
The Food and Drug Administration is reviewing Avandia’s safety profile and will present its findings to an advisory committee in July, officials said in a March 30 letter to two U.S. senators who released a critical report about the drug.
“Avandia withdrawal from the U.S. market would tilt the liability risk towards the top end of our $1 billion to $6 billion range,” Amusa said in the March 4 note to investors. He still rates the company as a “buy.”
Status Conference
Lanier, who won the first jury verdict against Merck & Co. over its withdrawn painkiller Vioxx in 2005, resolved more than 500 Avandia cases, the people said. Weiss, who was among a group of plaintiffs’ lawyers who negotiated a $3.75 billion settlement of suits over Wyeth’s diet drugs in 2000, resolved more than 200 Avandia cases, the people added.
Weiss announced he’d settled his Avandia cases at a status conference last month in Philadelphia Common Pleas Court on the suits slated to be tried there, the people said.
Ted Oshman, a Manhattan-based plaintiffs’ lawyer, also settled a number of cases, the people said. None of the three attorneys returned calls for comment on the accords.
The case is In Re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-1871, U.S. District Court for Eastern District of Pennsylvania (Philadelphia).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; Trista Kelley in London at tkelley2@bloomberg.net
Source
Glaxo, the U.K.’s biggest drugmaker, agreed to resolve more than 700 Avandia suits filed by three attorneys, including Houston-based plaintiffs’ lawyer Mark Lanier and Philadelphia- based litigator Sol Weiss, the people said. The settlements come as Glaxo is set to face its first Avandia trial in state court in Philadelphia in July. The company faces about 4,000 lawsuits that have been filed so far over the drug.
“Settlement of litigation tends to be seen positively by the market because it’s minimizing risk,” Michael Leacock, an analyst at Royal Bank of Scotland Group Plc, said by phone from London today. “This all seems quite manageable.”
Mary Anne Rhyne, a U.S. spokeswoman for London-based Glaxo, said she couldn’t immediately comment on the Avandia settlements today.
Regulators approved Avandia for sale in the U.S. in 1999 and the medicine tallied annual revenue of $3 billion by 2006, including sales of a combination of Avandia and another drug.
Avandia sales plunged after a May 2007 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks, prompting U.S. and European regulators to order Glaxo to strengthen its warnings. Avandia was the world’s best-selling diabetes pill before safety concerns emerged.
Legal Reserves
Last month, Glaxo officials reported first-quarter profit that beat analysts’ estimates. They also noted the reserves budgeted for legal matters for the quarter increased by 210 million pounds ($311.8 million) because of “the progress we are making toward settlement of existing cases,” according to a April 28 statement.
Gbola Amusa, an analyst at UBS AG in London, said in March Glaxo faces as much as $6 billion in liability on Avandia and there’s a risk that U.S. regulators may force the company to take the drug off the market.
The Food and Drug Administration is reviewing Avandia’s safety profile and will present its findings to an advisory committee in July, officials said in a March 30 letter to two U.S. senators who released a critical report about the drug.
“Avandia withdrawal from the U.S. market would tilt the liability risk towards the top end of our $1 billion to $6 billion range,” Amusa said in the March 4 note to investors. He still rates the company as a “buy.”
Status Conference
Lanier, who won the first jury verdict against Merck & Co. over its withdrawn painkiller Vioxx in 2005, resolved more than 500 Avandia cases, the people said. Weiss, who was among a group of plaintiffs’ lawyers who negotiated a $3.75 billion settlement of suits over Wyeth’s diet drugs in 2000, resolved more than 200 Avandia cases, the people added.
Weiss announced he’d settled his Avandia cases at a status conference last month in Philadelphia Common Pleas Court on the suits slated to be tried there, the people said.
Ted Oshman, a Manhattan-based plaintiffs’ lawyer, also settled a number of cases, the people said. None of the three attorneys returned calls for comment on the accords.
The case is In Re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-1871, U.S. District Court for Eastern District of Pennsylvania (Philadelphia).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; Trista Kelley in London at tkelley2@bloomberg.net
Source
Friday, February 26, 2010
Monday, February 22, 2010
Saturday, February 20, 2010
GSK - Avandia: “Rosiglitazone should be removed from the market,”
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
Wednesday, November 12, 2008
GSK - Avandia: not so rosy
GlaxoSmithKline's diabetes medicine Avandia failed to significantly reduce progression of plaque build up in coronary arteries in a clinical trial presented at a major heart meeting on Wednesday.
A positive outcome would have been welcome news for Glaxo as Avandia has been under a cloud since an analysis of past clinical studies appeared to find increased risk of heart attack not seen with similar diabetes medicines.
Sales of the drug fell 23 percent in the third quarter to $314 million and Glaxo was forced to defend the drug again last month amid charges from a public advocacy group that Avandia had caused more than a dozen cases of liver failure.
The new clinical trial of 672 patients with type 2 diabetes and heart disease compared Avandia's impact on atherosclerosis -- or buildup of fatty plaque in the arteries -- with that of a much older, generically available diabetes medicine called glipizide.
More
A positive outcome would have been welcome news for Glaxo as Avandia has been under a cloud since an analysis of past clinical studies appeared to find increased risk of heart attack not seen with similar diabetes medicines.
Sales of the drug fell 23 percent in the third quarter to $314 million and Glaxo was forced to defend the drug again last month amid charges from a public advocacy group that Avandia had caused more than a dozen cases of liver failure.
The new clinical trial of 672 patients with type 2 diabetes and heart disease compared Avandia's impact on atherosclerosis -- or buildup of fatty plaque in the arteries -- with that of a much older, generically available diabetes medicine called glipizide.
More
Wednesday, February 06, 2008
GSK - Avandia - ACCORD - clinical trials, ain't they a bitch!
The National Heart, Lung, and Blood Institute has stopped the intensive glucose lowering arm of the ACCORD trial due to excess mortality in that treatment arm.
ACCORD was designed to evaluate the impact of different glucose and lipid-lowering strategies on cardiovascular events in more than 10,251 participants with type 2 diabetes.
According to a press release, there have been 257 deaths in the intensive-treatment group and 203 in the standard treatment group, which is an excess of 54 deaths, or three per 1,000 participants each year, over an average of fours years of treatment.
The NHBLI said, however, that the death rates in both groups were lower than mortality seen in similar populations in other studies.
Patients in the intensive-glucose lowering arm received a number of medications, including rosiglitazone (Avandia), a drug that has been linked to excess events in studies published over the past year.
ACCORD was designed to evaluate the impact of different glucose and lipid-lowering strategies on cardiovascular events in more than 10,251 participants with type 2 diabetes.
According to a press release, there have been 257 deaths in the intensive-treatment group and 203 in the standard treatment group, which is an excess of 54 deaths, or three per 1,000 participants each year, over an average of fours years of treatment.
The NHBLI said, however, that the death rates in both groups were lower than mortality seen in similar populations in other studies.
Patients in the intensive-glucose lowering arm received a number of medications, including rosiglitazone (Avandia), a drug that has been linked to excess events in studies published over the past year.
"Because of the recent concerns with rosiglitazone, our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link," Dr. William Friedewald, clinical professor of medicine and public health at Columbia University in New York and one of the directors of the trial, said in a statement.
"A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes," said Elizabeth G. Nabel, M.D., director of the NHLBI.
"Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD."
Subscribe to:
Posts (Atom)