October 24, 2005 |
Drugstore shelves are brimming with shakes, herbs and other products to facilitate weight loss -- but the vast majority of them have not been shown to work. It's possible that a proven medication that helps modestly with weight loss may join their ranks next year. The pharmaceutical company GlaxoSmithKline has asked the Food and Drug Administration for permission to sell a low-dose version of its diet drug Xenical over the counter.
March 14, 2007 |
GlaxoSmithKline won U.S. approval Tuesday for a once-a-day breast cancer pill that the drug maker hopes will launch a new era for its oncology business. The Food and Drug Administration cleared the drug, called Tykerb, for patients with advanced breast cancer in combination with Roche Holding's oral chemotherapy drug, Xeloda, or capecitabine. It is the first of four cancer drugs that Glaxo hopes to have approved by 2010.
July 1, 2005 |
GlaxoSmithKline aims to launch five major vaccines over the next five years targeting markets that could reach $18 billion by 2010, Europe's biggest drug maker said Thursday. The company also plans to double manufacturing capacity in Dresden, Germany, for its flu shot Fluarix to 80 million doses a year by 2008 in order to supply the U.S. market. Vaccines have long been viewed as a low-growth, low-price business, but Glaxo says this is changing with the arrival of new technologies.
June 3, 2004 |
State Atty. Gen. Eliot Spitzer filed a lawsuit Wednesday charging one of the largest pharmaceutical companies in the world with hiding significant information about the benefits and risks of its antidepressant medicine Paxil for use in teenagers. The drug has been banned in England and other countries because of concern about side effects including violence and suicidal thoughts and behavior. In the United States, a strong federal warning was issued last June about its use by children.
August 27, 2004 |
GlaxoSmithKline agreed Thursday to release all data on the safety and effectiveness of its drugs to settle a lawsuit by New York's attorney general, who accused the pharmaceutical maker of withholding negative information about its antidepressant drug Paxil. Glaxo will put summaries of all its studies since December 2000 in a clinical trial registry on its website. The London-based company is the first major drug maker to agree to disclose all its studies. The company also will pay $2.
February 8, 2007 |
The Food and Drug Administration on Wednesday approved the first diet drug to be sold without a prescription. The drug is a lower-dose version of the prescription medicine Xenical and will become available to consumers this summer under the name alli. The pill will be marketed to people over 18 and will compete against nutritional supplements, which do not require FDA approval and the rigorous safety and efficacy testing that entails.
October 11, 2002 |
A federal judge in Los Angeles has rescinded an order for a temporary injunction that would have barred British pharmaceutical giant GlaxoSmithKline from running television ads for its Paxil antidepressant that said the drug was not habit-forming. U.S. District Judge Mariana Pfaelzer's decision Thursday was a victory not only for GlaxoSmithKline but also for the Food and Drug Administration, which had approved the ads.
August 24, 2002 |
The federal judge who ordered pharmaceutical giant GlaxoSmithKline to halt television ads that claim its bestselling anti-depression drug is not habit-forming has issued a stay of her ruling, pending additional information from the Food and Drug Administration. But Judge Mariana Pfaelzer of the U.S. District Court in Los Angeles did not address assertions by the FDA and the Justice Department that she had no authority to rule in the matter, according to lawyers involved in the case.
September 25, 2007
Re "Opening up the findings of drug trials," Sept. 17 I agree with this article, which rightfully discusses the need for increased transparency of clinical-trial reporting for pharmaceuticals. But it incorrectly uses Avandia to make its case. Avandia remains the most-studied oral anti-diabetic treatment available to patients.
July 27, 2007 |
The widely used diabetes drug Avandia increases the chance of serious heart problems, including a 30% to 40% higher risk of myocardial ischemia, or decreased flow of blood to the heart, according to documents released by the Food and Drug Administration on Thursday. Diabetics taking the GlaxoSmithKline drug in combination with insulin were at even greater risk, the FDA found in a review of dozens of drug studies.