The big drugmaker blames the bad news on safety concerns surrounding its Avandia diabetes pill, which experienced a sales drop of 56 percent, and generic competition to the Coreg high blood pressure med and the Wellbutrin antidepressant. To cope with the downturn, Glaxo has been eliminating jobs and buying back shares.
Avandia “lost many users last [...]

The agency sent the drugmaker a harsh warning letter for failing to include nine Avandia post-marketing studies - seven clinical trials and two observational trials - in mandatory periodic and annual reports that are supposed to include a wide range of activities and events associated with each and every product. The FDA letter, which was [...]

They say there is “no defense” for prescribing the controversial if widely used diabetes pill after warnings were issued that the drug shouldn’t be used in patients with heart problems, The Scotsman writes.
The consultants, who work in the National Health Service Greater Glasgow and Clyde area, recommend that new patients not be given Avandia, general [...]

Ron Krall, who found himself in the thick of controversy last year when Glaxo’s Avandia diabetes pill was linked to a high rate of heart attack and strokes, is leaving the drugmaker, a spokeswoman confirms. In a note, she tells us that Krall is retiring, although “the timing will depend on identifying his successor,” who [...]

The government’s watchdog agency is investigating whether the FDA’s review process cleared two blockbuster meds - Avandia and Vytorin - without sufficient proof of their safety or effectiveness, the Associated Press reports. Specifically, the GAO has agreed to study whether the FDA should approve drugs based on biological measures, like cholesterol and blood sugar, without [...]

The drugmaker is having a rough time. The earnings report released today shows a steeper decline in fourth-quarter profit than analysts estimated and, to top it off, Glaxo ceo JP Garnier says earnings will drop this year, mostly due to docs abandoning the Avandia diabetes pill over safety concerns.
In response, Glaxo shares plunged as [...]

The results of the ACCORD trial, which was designed to determine whether treating diabetes would reduce heart disease, found that no particular drug was responsible for serious cardiovascular problems. This would appear to contradict the controversial meta-analysis published last spring in the New England Journal of Medicine, which contended Avandia increased the risk of heart [...]

Ever wonder how Glaxo was able to respond so quickly and authoritatively to the controversial meta-analysis published last May in The New England Journal of Medicine? This was the study linking the Avandia diabetes pill to a 43 percent increased risk in heart attacks and strokes. Well, it turns out that a peer reviewer for [...]

After gazing across the pond at the drug safety debate in the US, some UK politicians and docs would like to see the Medicines and Healthcare products Regulatory Agency (MHRA) become more aggressive in reviewing drugs for safety signals. The concern is that, after such high-profile controversies as Vioxx and Avandia, the UK watchdog lacks [...]

Just one more example of investor dissatisfaction with JP Garnier. The North Yorkshire Pension Fund and the Avon Pension Fun, which together manage more than $6 billion in assets, are vying to be lead plaintiffs in a US class-action lawsuit filed against the drugmaker for misleading investors over the risks of its Avandia diabetes pill.
The [...]