Category: Oral Medication

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FDA May Stop Avandia Trials

The Food and Drug Administration (FDA) is considering stopping a safety study involving thousands of patients taking GlaxoSmithKline PLC's Avandia according to the Wall Street Journal. Avandia has been linked to an increased risk of heart attack. If the trial is stopped, the FDA will also consider asking Glaxo to stop selling the drug, a decision that could also...
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New Type 2 Diabetes Drug May Be On The Way

An Ohio State University study found that an experimental oral drug lowers blood sugar levels and inflammation in mice with type 2 diabetes, suggesting that the medication could someday be used to treat humans with type 2 diabetes. The drug consists of a synthetic molecule that stops the biological activity of a protein called macrophage...
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First Governmental Lawsuit Against GSK Over Avandia

On Friday over its diabetes drug Avandia, charging a decade of false advertising and seeking compensation on behalf of patients and providers in California. MercuryNews reports the county claims the drugmaker made billions of dollars on Avandia, which caused heart attacks and strokes....
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GSK Rejects Allegation Regarding Avandia Safety

GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance report regarding Avandia. GSK said it rejects any allegations of concealing safety information or acting inappropriately on behalf of patients. GSK also said it disagrees with the Committee’s decision to publish a Staff Report with the errors of fact, omissions, and inferences detailed in GSK’s White Paper....
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FDA Advises Patients To Continue Taking Avandia

The Food and Drug Administration (FDA) announced it would be reviewing data submitted in August 2009, from a large, long-term clinical study (RECORD study) on possible risks associated with the diabetes drug, Avandia (rosiglitazone). The FDA said it will complete its review of the data from the RECORD study, and will then...
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Avandia Harms The Heart, Studies Find

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos...
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Novo Nordisk starts phase 1 trial with long-acting oral GLP-1 analogue

Novo Nordisk announced that it has initiated its first phase 1 clinical trial with a long-acting oral GLP-1 analogue (NN9924). The aim of the trial, which is conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. Results from the trial, which is planned to enroll about 155 people, are expected to be reported in 2011...
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