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.
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.
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.
June 9, 2003 |
In the 19th century, men who suffered from symptoms caused by an enlarged prostate often carried canes with secretly hollowed-out shafts. If a man felt the sudden and urgent need to urinate and couldn't reach a bathroom in time, the cane doubled as an emergency urinal. Fortunately, physicians today can offer men far more practical and effective ways to cope with the annoyance of an enlarged prostate.
October 18, 2011 |
A malaria vaccine under development has passed a critical milestone with researchers reporting Tuesday that the shots protect about half of all children from the disease. The Phase 3 clinical trial was conducted among 6,000 sub-Saharan African children five to 17 months old who were given three doses. The vaccine is designed to prevent the malaria parasite from infecting, maturing and multiplying in the liver and reentering the bloodstream. A malaria vaccine has been a goal for more than 20 years.
June 19, 2006 |
WALTER Skotchdopole worked for 20 years as a police officer and 20 years in the film industry before succumbing to the relentless decline of Alzheimer's disease. In his prime, he joked with everyone he met. By his early 70s, he had become a shell of his former self. "He's there, but he's not," says his son James Skotchdopole. "There's no real interaction, no real stake in life." Walter Skotchdopole had tried several drugs, with no noticeable improvement.