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- Glaxo Gets an FDA Warning... With Teeth
- Well before Vytorin became a cause célèbre -- which is to say, about a year ago -- GlaxoSmithKline's Avandia was the drug getting slapped around by critics for, in that case, possible heart problems that had possibly been downplayed or ignored. That case, which led to new warnings on the...
- Blog posts 2008-04-12
Additional Resources
- Therapeutic Clinical Intelligence — Type-2 Diabetes Pipeline Report Now Available
- DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/c83cd1/therapeutic_clinic) has announced the addition of the "Therapeutic Clinical Intelligence - Type-2 Diabetes Pipeline" report to their offering. Diabetes affects more than an estimated 18 million people in the United States and approximately 194 million adults worldwide. The World Health Organization projects...
- Articles 2008-06-16
- MultiVu Video Feed: Large, Long-Term Veterans Affairs Diabetes Trial Reveals Important Cardiovascular Safety News on AVANDIA
- NEW YORK, June 9 /PRNewswire/ -- SATELLITE FEED: Monday, June 9th, 2008 1:00 PM - 1:15 PM ET Galaxy 26 Transponder 24 C-Band Downlink Freq: 4180 H NEWS: LARGE, LONG-TERM VETERANS AFFAIRS DIABETES TRIAL VADT REVEALS ...
- Articles 2008-06-09
- Study: Hypoglycemia raises diabetics' heart risk
- SAN FRANCISCO -- A recent event of hypoglycemia, or extremely low blood sugar, in type 2 diabetics was a major predictor of heart attack, stroke and death, a just-finished study by the Department of Veterans Affairs found. The study, presented Sunday at the American Diabetes Association conference here,...
- Articles 2008-06-09
- Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of AVANDIA®
- SAN FRANCISCO, June 9 /PRNewswire/ -- Two long-term, large-scale and independent studies evaluating cardiovascular CV outcomes in people with type 2 diabetes enrolled more than 9,300 patients taking AVANDIAR rosiglitazone maleate and provide more than 20,000 patient years of additional experience with AVANDIA. The Veterans Affairs Diabetes Trial...
- Articles 2008-06-09
- Large, Long-Term Veterans Affairs Diabetes Trial Reveals Important Cardiovascular Safety News on AVANDIA®
- Primary Findings from VADT on Benefit of Intensive Blood Sugar Control Are Not Statistically Significant but Show Favorable Trend in Reducing Most CV Events SAN FRANCISCO, June 8 /PRNewswire/ -- Findings from the Veterans Affairs Diabetes Trial VADT, a large, long-term and independent cardiovascular CV outcomes study...
- Articles 2008-06-08
- Black-box warnings on Rx products up sharply in '07
- BLACK-BOX warnings on pharmaceutical products continued to surge upward in 2007. The FDA's MedWatch reporting system showed that blackbox warnings rose 26% to 73 in 2007 from 58 in 2006, according to IMS Health's US Pharmaceutical Market Performance Review, issued in March. Major black-box warnings for 2007 included:...
- Articles 2008-05-01
- New Worries Over Blockbuster Meds Avandia, Fosamax
- Avandia and Fosamax, widely prescribed drugs used to treat two common health conditions, show further evidence of being linked to adverse events. a family of diabetes drugs that includes blockbuster Avandia -- appears to be linked with an increased risk for bone fractures. And a second study found that...
- Articles 2008-04-28
- Avandia fears knock hole in GSK's profits
- GlaxoSmithKline, the world's No 2 pharmaceuticals firm, announced disappointing first-quarter results yesterday, with profits down on the same period last year, as sales of Avandia continued to fall. However, most analysts were relieved that the figures were not worse and predicted a "period of stability". GSK shares...
- Articles 2008-04-24
- GlaxoSmithKline profits slide in first quarter
- LONDON AFP — British pharmaceutical giant GlaxoSmithKline said on Wednesday that first-quarter net profits tumbled, partly because of sliding sales of diabetes drug Avandia. Net profits dived 13.7 percent to 1.307 billion pounds (1.63 billion euros, 2.6 billion dollars) in the three months ending March 31, 2008, compared...
- Articles 2008-04-23
- Concern From Doctors Regarding the Cardiovascular Safety of GlaxoSmithKline's Avandia Increases Nine-Fold Following Publication of Meta-Analysis
- Nearly Three-Quarters of Physicians Have Switched Patients to Merck's Januvia, According to a New Report from Decision Resources WALTHAM, Mass., April 22 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the percentage of primary care...
- Articles 2008-04-22
- US drug watchdog raps GSK over Avandia disclosures
- Business News IN BRIEF *GlaxoSmithKline failed to report some post-marketing data on its diabetes drug Avandia, the US Food and Drug Administration warned yesterday. An FDA letter said an inspection last year found the UK pharmaceuticals giant did not include multiple post-approval studies, as required in periodic...
- Articles 2008-04-09
- GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting
- LONDON and PHILADELPHIA, April 8, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline today confirmed it has received a warning letter from the US Food and Drug Administration FDA related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year. ...
- Articles 2008-04-08
- New rotavirus vaccine OKd for U.S. children
- GlaxoSmithKline P.L.C. received U.S. approval yesterday for Rotarix, its new vaccine against rotavirus, which kills hundreds of thousands of children in the developing world. The approval is welcome news for GlaxoSmithKline, which announced worldwide layoffs last year after its second-leading seller, the diabetes drug Avandia, was linked to heart attacks....
- Articles 2008-04-04
- Avandia May Slow Atherosclerosis After Bypass Surgery
- The controversial diabetes drug Avandia appears to slow the progression of atherosclerosis in diabetic patients who have undergone cardiac bypass surgery, thus protecting them from new cardiac problems, according to the results of a small study. Avandia rosiglitazone has been associated with increased risk of heart attack and heart...
- Articles 2008-04-01
- State aid is no cure for drug maker.(Triangle)
- GlaxoSmithKline opted out of a 2005 state incentive agreement that would have paid it $1.4 million for creating 200 jobs at its plant in Zebulon and keeping them 10 years. Spokeswoman Stefanie Mendell says the British drug maker filled the jobs but can't keep all of them....
- Articles 2008-04-01
- Rosiglitazone is associated with increased cardiovascular mortality
- Background: Rosiglitazone Avandia is one of two thiazolidinedione agents available for managing glucose levels in patients with type 2 diabetes (troglitazone [Rezulin] was recalled in 2000 because of hepatotoxicity). It is well known that cardiovascular morbidity and mortality are serious issues in patients with diabetes; however, earlier studies may not...
- Articles 2008-03-15
- Antidote
- Researchers at the National Institutes of Health released findings of the ACCORD study which appeared to show that driving blood sugar to low levels in diabetics leads to an increased rate of dying. Over 10,000 patients were studied, with 257 deaths in the intensive therapy group and 203 in the...
- Articles 2008-03-01
- Glaxo hit by sliding Avandia sales.
- GlaxoSmithKline's problematic type-two diabetes product, Avandia, has hit an otherwise solid performance. Richard Hemming GlaxoSmithKline 's GSK shares fell almost 9 per cent after it lowered next year's earnings expectations. That partly reflects the fact that sales of one of its lead drugs,...
- Articles 2008-02-12
- Diabetes drug and conflicts of interest
- So much for confidential peer review. Last May, a controversial paper in the New England Journal of Medicine NEJM reported that a popular diabetes drug--rosiglitazone, sold as Avandia--substantially hikes a user's risk of heart attack (SN: 6/23/07, p. 397). But according to an ongoing investigation by the U.S....
- Articles 2008-02-09
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