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Astrazeneca Company

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BUSINESS
December 11, 2007 | From Reuters
U.S. regulators said Monday that they had cleared AstraZeneca's bestselling heartburn drugs Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk of hip fractures. The Food and Drug Administration concluded the drugs had no negative effect on the heart, an issue under scrutiny after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from surgery to remedy severe acid reflux disease.
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BUSINESS
December 11, 2007 | From Reuters
U.S. regulators said Monday that they had cleared AstraZeneca's bestselling heartburn drugs Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk of hip fractures. The Food and Drug Administration concluded the drugs had no negative effect on the heart, an issue under scrutiny after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from surgery to remedy severe acid reflux disease.
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BUSINESS
September 25, 2002 | DENISE GELLENE, TIMES STAFF WRITER
A Food and Drug Administration advisory panel Tuesday recommended approval for an AstraZeneca cancer medication that agency reviewers had criticized for showing only "hints of drug activity." Shares of AstraZeneca and its closest rivals soared after the panel of outside experts voted 11 to 3 to endorse Iressa. The FDA is not required to take the advice of its experts, but frequently does so.
BUSINESS
May 19, 2007 | From Times Wire Services
AstraZeneca said U.S. regulators had approved a new once-daily version of its Seroquel schizophrenia drug. Seroquel is the London-based company's second-biggest-selling drug, with global sales of $3.4 billion last year. Analysts said Food and Drug Administration approval of Seroquel XR was important to extend the life cycle of the family of drugs. The new version of the drug is under patent until 2017.
BUSINESS
October 30, 2004 | From Bloomberg News
Britain's AstraZeneca said U.S. prosecutors demanded documents related to the status of the company's ulcer medicines, Prilosec and Nexium, on the lists of drugs covered by health plans. The U.S. attorney's office for the Eastern District of Pennsylvania is probing the billing practices of insurers and pharmacy-benefit managers.
NATIONAL
August 13, 2003 | From Times Wire Reports
The Food and Drug Administration approved the cholesterol-lowering drug called Crestor after long debate about the risk of side effects. Made by AstraZeneca Pharmaceuticals, Crestor, a statin, comes with a warning about taking higher-than-recommended doses, which have contributed to rare cases of a potentially fatal, muscle-destroying condition called rhabdomyolysis.
BUSINESS
May 19, 2007 | From Times Wire Services
AstraZeneca said U.S. regulators had approved a new once-daily version of its Seroquel schizophrenia drug. Seroquel is the London-based company's second-biggest-selling drug, with global sales of $3.4 billion last year. Analysts said Food and Drug Administration approval of Seroquel XR was important to extend the life cycle of the family of drugs. The new version of the drug is under patent until 2017.
BUSINESS
November 27, 2001 | Bloomberg News
AstraZeneca and Merck & Co. said the Food and Drug Administration approved six-month extensions of exclusive marketing rights for Lisinopril, a heart drug that each company sells in the U.S. under a different name. The FDA granted the additional protection until June 29 after each company supplied the agency with research on the use of the drug in children. AstraZeneca sells the drug as Zestril and Merck sells it as Prinivil.
NATIONAL
March 12, 2005 | From Times Wire Reports
AstraZeneca has received its second warning in four months from the U.S. Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor, the company said in New York. The latest letter said claims that Crestor lowers cholesterol better than Pfizer Inc.'s Lipitor were misleading because it cherry picked results from a study comparing the two medicines.
BUSINESS
June 26, 2002 | Bloomberg News
AstraZeneca persuaded a federal judge to dismiss two antitrust lawsuits filed by consumers who accused the drug maker of filing patent infringement claims to block generic competition to Prilosec. U.S. District Judge Jed Rakoff said the plaintiffs failed to prove that AstraZeneca's suits against 10 generic-drug makers were sham litigation designed to thwart competition to the heartburn drug. The antitrust lawsuits were filed last year on behalf of consumers and union insurance plans.
BUSINESS
April 24, 2007 | From Bloomberg News
AstraZeneca, struggling to develop new medicines, said Monday that it agreed to buy biotechnology company MedImmune Inc. for $15.2 billion in cash to gain flu vaccines and an antiviral treatment for babies. MedImmune investors will get $58 a share, AstraZeneca said. That's 21% more than MedImmune's Friday closing price of $48.01. MedImmune, based in Gaithersburg, Md., put itself up for sale April 12 under pressure from billionaire Carl Icahn and other shareholders.
BUSINESS
January 12, 2007 | From the Associated Press
The announcement by Bristol-Myers Squibb Co. and AstraZeneca on Thursday that they will share the risks and rewards of developing two diabetes drugs highlights how expensive and precarious the route to product approval can be. By joining forces, the companies lower the financial risks of drug development at a time when numerous high-profile products haven't proved effective in late-stage clinical trials. Under the deal, AstraZeneca will pay as much as $1.
BUSINESS
November 17, 2005 | From Bloomberg News
British drug maker AstraZeneca didn't deceive consumers about the benefits of its Nexium heartburn medication, a federal judge ruled as she threw out a class-action lawsuit against the company. U.S. District Judge Sue Robinson in Wilmington, Del., granted AstraZeneca's motion to dismiss the case after finding that statements made in advertising were consistent with the label approved by the Food & Drug Administration.
BUSINESS
July 12, 2005 | From Bloomberg News
AstraZeneca will pay as much as $340 million to Avanir Pharmaceuticals to develop experimental heart-disease treatments. The companies will work to develop medicines from so-called reverse cholesterol transport enhancing compounds, which may allow the body to reverse damage to blood vessels, AstraZeneca said. AstraZeneca will pay $10 million now with as much as $330 million linked to the experimental drugs meeting development goals, the companies said.
NATIONAL
June 7, 2005 | From Times Wire Reports
AstraZeneca's Crestor cholesterol drug may have triggered a temporary weakening in a 67-year-old woman's heart, Mayo Clinic doctors said in a letter published in the Annals of Internal Medicine. Kidney and muscle complications from Crestor may have caused the woman's heart to pump about a fifth as much blood as normal on each beat, James Ireland, a Mayo Clinic doctor, said in Rochester. He was one of four authors of the letter, published under the heading "Clinical Observation."
NATIONAL
March 12, 2005 | From Times Wire Reports
AstraZeneca has received its second warning in four months from the U.S. Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor, the company said in New York. The latest letter said claims that Crestor lowers cholesterol better than Pfizer Inc.'s Lipitor were misleading because it cherry picked results from a study comparing the two medicines.
BUSINESS
October 25, 2002 | Chris Elser, Bloomberg News
LONDON -- AstraZeneca, Merck & Co., Bristol-Myers Squibb Co. and Schering-Plough Corp. on Thursday reported that third-quarter earnings fell as the arrival of cheaper generic drugs took sales and orders away from their top-selling medications. AstraZeneca, Europe's second-largest drug maker, said net income dropped 5% as demand for the ulcer treatment Prilosec declined in anticipation of generic rivals in the U.S. next year.
BUSINESS
August 13, 2003 | From Bloomberg News
AstraZeneca won Food and Drug Administration approval of its Crestor cholesterol-lowering drug, increasing competition for the world's top-selling medicine, Pfizer Inc.'s Lipitor. AstraZeneca is readying a marketing campaign for Crestor that some estimate will cost about $1 billion. Crestor worked better than other cholesterol drugs in some tests, and London-based AstraZeneca will stress this as Crestor competes with drugs that doctors already know well, analysts said. With U.S.
BUSINESS
March 4, 2005 | From Associated Press
Pharmaceutical giant AstraZeneca told an FDA committee this week that the failure of its last-chance cancer drug, Iressa, to significantly improve survival rates in a clinical trial was a surprise and that a review was underway to determine why the product didn't do better. Iressa won Food and Drug Administration approval in 2003 for advanced lung cancer patients who had exhausted standard therapy after studies showed that it shrank tumors in some terminally ill patients.
BUSINESS
December 23, 2004 | From Associated Press
The Food and Drug Administration is seeking to block an ad touting the safety of the cholesterol drug Crestor, calling the claims misleading. The agency asked the drug maker, AstraZeneca, to "immediately cease the dissemination" of the ad. AstraZeneca spokeswoman Emily Denney said that the ad ran for only a short time and that the FDA had been advised that it was no longer being used.
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