Tag Archives: Safety

Takeaways from the Post-Approval Summit

Dr. Richard Gliklich, president of Quintiles Outcome and a professor at Harvard Medical School, highlights the most prominent post-approval issues and risks coming out of this year’s Post-Approval Summit, held on May 7th-8th. Brand managers prodding products across the regulatory finish line to commercialization are finding themselves in yet another race, instead of in the […]
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Monsanto's Rat Tumor Scare: A Wake-Up Call for the Pharma Industry?

ARE Monsanto’s RAT-TUMOUR SCARES A WAKE-UP CALL TO THE PHARMA INDUSTRY? By Reflector, Brussels correspondent. The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns of European pharmaceutical executives — but the significance of the debate […]
Posted in Biotech, Europe, Gene therapy, Guest Blog, Op-Ed, Safety, Technology | Also tagged , , , , , | 2 Comments

Europe Unites Over Counterfeiting

Imitation may the sincerest form of flattery, but it isn’t always welcome. Particularly when the imitations are fakes through and through. That explains why Europe’s new rules to combat counterfeit medicines are winning such widespread applause, says Reflector. It isn’t customary for European Union legislation to win backing from all sides. Usually, there’s a large […]
Posted in Europe, Global, Guest Blog, Supply Chain | Also tagged , | Leave a comment

Pfizer Responds to Adverse Events Report

A report released last week by the The Institute for Safe Medication Practices (and covered yesterday on PharmExec.com), listed Pfizer’s smoking cessation drug Chantix as the number one most reported drug for adverse reactions in the first quarter of 2008. The report states that FDA received 1,001 reports of serious side effects for varenicline (the […]
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