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Pharmaceuticals: European Regulatory Clearance

Today on IPcopy we have a guest post from Rob Jacob of Stephenson Harwood LLP on the subject of pharmaceutical name approvals.

Choosing a name for a prescription pharmaceutical product is not an easy task. 1,022 more words

General Interest

Avandia Associated with 100 000 Heart Attacks

Avandia (generic rosiglitazone) is a type 2 diabetes drug manufactured by GlaxoSmithKline and has been linked to adverse cardiovascular side effects. The U.S. Food and Drug Administration (FDA) reported that an estimated 100 000 heart attacks have been linked to Avandia. 156 more words

Pharmaceutical Products

Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials

Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of ¬†prominent cardiovascular and diabetes researchers.

It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. 72 more words

Policy & Ethics

Why the EU banned Avandia but the FDA didn't

Public release date: 23-Sep-2010

- New evidence surfaced in 2009 that suggested GSK hid important information about the drug’s safety from officials

- Wyeth’s diet drug Fen-Phen stayed on the market for almost 30 years until the FDA reviewed reports from independent physicians… 991 more words

Lethal Or Unintended Side Effects