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BUSINESS
June 5, 2013 | By David Sell, Inquirer Staff Writer
The controversial diabetes drug Avandia, made by GlaxoSmithKline, might not cause as many heart problems as was thought, the U.S. Food and Drug Administration said in a report released Monday. The report was prepared in advance of an unusual advisory-committee hearing scheduled this week to reexamine a clinical trial called Record, done by Glaxo in the mid-2000s to support continued approval of the medication. The FDA is in something of a bind with this drug. It approved the medication in 1999, but then was criticized after a 2007 study found cardiovascular problems in those who used it. The agency did not ban the drug, but in 2007 added restrictions to the official label on how it could be prescribed.
BUSINESS
June 13, 2007 | By Karl Stark, Inquirer Staff Writer
Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine. But within two weeks, his ankles started swelling. His weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs, who runs the Lionville Natural Pharmacy & Health Food Store in Chester County. The symptoms stopped after he went off the drug, he said. Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk.
BUSINESS
November 17, 2012 | By Jef Feeley and Catherine Larkin, Bloomberg News
GlaxoSmithKline P.L.C. agreed to pay $90 million to settle claims by 37 states, including Pennsylvania and New Jersey, and the District of Columbia that the company illegally promoted the Avandia diabetes medicine. The settlement resolves claims by state attorneys general that the London-based Glaxo misled consumers about whether Avandia caused heart attacks and strokes in order to pump up sales. The company has paid more than $3 billion to resolve government probes of its marketing of Avandia and other medications, as well as patient lawsuits over the diabetes drug.
BUSINESS
June 8, 2013 | By David Sell, Inquirer Staff Writer
A splintered panel of advisers to the U.S. Food and Drug Administration recommended Thursday that the agency modify an extra warning on the type 2 diabetes drug Avandia, made by pharmaceutical giant GlaxoSmithKline. Thirteen of the 26 panelists voted to keep the extra warning, which refers to increased risk of heart attack, with modifications, but there was little consensus on how to change the warning. Seven voted to remove it. Five voted to keep it as is. One voted to withdraw approval of the drug completely.
BUSINESS
June 29, 2012 | By David Sell and INQUIRER STAFF WRITER
GlaxoSmithKline lost a federal appeals court decision Thursday that could have costly repercussions for the company and other drugmakers whose products are later subject to investigations, recalls and lawsuits. The U.S Court of Appeals for the Third Circuit in Philadelphia ruled that Humana, one of the nation's largest insurance companies, could sue Glaxo to recover costs incurred by some Medicare patients who used versions of the diabetes drug Avandia, which was later pulled from the market because it was found to cause heart problems.
BUSINESS
June 13, 2007 | By Karl Stark INQUIRER STAFF WRITER
Like many diabetics, pharmacist Ben Briggs was eager to see his blood sugar drop when he began taking his new medicine. But within two weeks, his ankles started swelling. His weight surged eight pounds, and he felt short of breath. "I was feeling awful," said Briggs, who runs the Lionville Natural Pharmacy & Health Food Store in Chester County. The symptoms stopped after he went off the drug, he said. Briggs wasn't taking Avandia, the GlaxoSmithKline drug caught in a media firestorm in recent weeks because of its alleged links to higher heart-attack risk.
BUSINESS
May 23, 2007 | By Jeff Gelles INQUIRER STAFF WRITER
A day after a new study suggested that the widely prescribed diabetes drug Avandia might increase the risk of heart attack and death, the prognosis for the medicine and its manufacturer, GlaxoSmithKline P.L.C., remained unclear. London-based GlaxoSmithKline, with U.S. headquarters in Philadelphia and North Carolina, stood by its statement Monday that it "strongly disagrees with the conclusions reached" in the New England Journal of Medicine article. At the same time, critics of the Food and Drug Administration continued to raise the specter of Vioxx, the Merck & Co. Inc. pain reliever that was pulled from the market three years ago after studies raised similar concerns and critics accused Merck of withholding other evidence of Vioxx's risks.
BUSINESS
November 20, 2008 | By Miriam Hill INQUIRER STAFF WRITER
A Maryland doctor said she felt "threatened and disappointed" after GlaxoSmithKline P.L.C. urged her to stop discussing her concerns that the company's diabetes drug, Avandia, caused heart problems. Her assertion marks the second time that GlaxoSmithKline has been accused of trying to intimidate a researcher who pointed out problems with Avandia, which before its side effects became well-known was the top-selling diabetes drug. In 2007, University of North Carolina researcher John Buse testified before Congress that GlaxoSmithKline had called him a liar and suggested it might sue him if his comments about Avandia's potential safety problems caused the company's stock to drop.
BUSINESS
July 18, 2010 | By Jeff Gelles, Inquirer Columnist
You might think two of last week's biggest stories - financial reform and controversy over the diabetes drug Avandia - had nothing to do with each other. If so, you'd be wrong. Both are about a fundamental problem in any market economy: Bad incentives for businesses, stoked by the demands of Wall Street, can imperil us all. During the housing bubble, mortgage brokers had bad incentives to write risky loans to unqualified buyers, because they could sell the mortgages and dodge the risks themselves.
BUSINESS
November 15, 2007 | By Karl Stark INQUIRER STAFF WRITER
GlaxoSmithKline P.L.C.'s once popular diabetes drug Avandia received the government's strongest warning - a black-box label - yesterday, indicating that users may face a small but increased chance of heart attacks. But the Food and Drug Administration stopped short of banning the former blockbuster, saying Avandia did not appear to be more dangerous than other diabetes medicines. "We are keeping Avandia on the market because we have concluded there isn't enough evidence that the risk of heart attacks is higher than other treatments," said Janet Woodcock, the FDA's acting director of the Center for Drug Evaluation and Research.
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BUSINESS
July 27, 2013
Drugmaker GlaxoSmithKline P.L.C. has agreed to pay $229 million to eight states to settle civil lawsuits related to the development and marketing of the diabetes drug Avandia and a separate suit by Louisiana related to other products. Glaxo's headquarters is in London but it operates in Philadelphia and surrounding areas. The company admitted no wrongdoing and disclosed the agreement in a filing with the Securities Exchange Commission. Avandia was approved by the FDA to treat type 2 diabetes, but later faced greater restrictions because of reports that it caused increased risk of heart attacks.
BUSINESS
July 26, 2013
In the Region REIT buys interest in 12 properties Resource Real Estate Opportunity REIT , a Philadelphia real estate investment company, agreed to pay $52.7 million for Paladin Realty Income Properties L.P. , Resource Real Estate announced. The deal includes interests in 10 apartment complexes with 2,513 units and two office complexes with 75,518 rentable square feet. Resource Real Estate is a subsidiary of Resource America Inc. , which managed $15.3 billion as of March 31. - Harold Brubaker Dow may sell three businesses Dow Chemical Co. , which bought the Philadelphia-based Rohm & Haas in 2009, may sell three businesses with $6 billion in combined revenue if the largest U.S. chemicals maker fails to improve profit margins.
BUSINESS
June 8, 2013 | By David Sell, Inquirer Staff Writer
A splintered panel of advisers to the U.S. Food and Drug Administration recommended Thursday that the agency modify an extra warning on the type 2 diabetes drug Avandia, made by pharmaceutical giant GlaxoSmithKline. Thirteen of the 26 panelists voted to keep the extra warning, which refers to increased risk of heart attack, with modifications, but there was little consensus on how to change the warning. Seven voted to remove it. Five voted to keep it as is. One voted to withdraw approval of the drug completely.
BUSINESS
June 5, 2013 | By David Sell, Inquirer Staff Writer
The controversial diabetes drug Avandia, made by GlaxoSmithKline, might not cause as many heart problems as was thought, the U.S. Food and Drug Administration said in a report released Monday. The report was prepared in advance of an unusual advisory-committee hearing scheduled this week to reexamine a clinical trial called Record, done by Glaxo in the mid-2000s to support continued approval of the medication. The FDA is in something of a bind with this drug. It approved the medication in 1999, but then was criticized after a 2007 study found cardiovascular problems in those who used it. The agency did not ban the drug, but in 2007 added restrictions to the official label on how it could be prescribed.
BUSINESS
October 14, 2012 | By David Sell, Inquirer Staff Writer
In a significant departure from industry practice, GlaxoSmithKline P.L.C., said it would make available to outside researchers the raw but anonymous patient data from clinical trials for drugs it has developed or discontinued, and its tuberculosis compound library. Pharmaceutical companies generally don't divulge such information, claiming that it is a proprietary secret. "As a truly global health care company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," Glaxo chief executive Andrew Witty said in a statement.
BUSINESS
July 27, 2012 | By David Sell, Inquirer Staff Writer
Billion-dollar fines for inappropriate drug marketing are considered part of the cost of doing business for pharmaceutical companies, industry critics argue, and such conduct won't change until more executives go to jail for illegal activity. Asked Wednesday about that criticism, GlaxoSmithKline chief executive officer Andrew Witty said he would let "governments and society" choose the drivers of enforcement. But he insisted that his company's operations have improved under his watch, whatever anyone might think in the wake of Glaxo's recent $3 billion payment for conduct under its previous leadership.
BUSINESS
June 29, 2012 | By David Sell and INQUIRER STAFF WRITER
GlaxoSmithKline lost a federal appeals court decision Thursday that could have costly repercussions for the company and other drugmakers whose products are later subject to investigations, recalls and lawsuits. The U.S Court of Appeals for the Third Circuit in Philadelphia ruled that Humana, one of the nation's largest insurance companies, could sue Glaxo to recover costs incurred by some Medicare patients who used versions of the diabetes drug Avandia, which was later pulled from the market because it was found to cause heart problems.
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