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PharmExec Direct | From the editors of Pharmaceutical Executive

July 1, 2010 | ISSUE NUMBER 155 VOL 8

Safety
Mixed Criticism on Avandia Effectiveness
GSK’s blockbuster diabetes drug Avandia was the subject of a number of studies this week offering good and bad news. But the company’s big challenge is going to be FDA’s advisory review panel set to meet in two short weeks.

Regulatory
FDA Prepares to Walk the Opiate REMS Line
FDA’s meeting on the adoption of REMS for certain prescription opioids doesn’t begin until July 22, but the agency’s proposal released Tuesday portends a meeting fraught with conflict over the balance between curbing abuse and protecting patient access.

Legal
AZ Celebrates Crestor Patent Win
AstraZeneca breathed a sigh of relief as the patent for the drug firm’s blockbuster statin Crestor was upheld in a US District Court.

Web Exclusive
A Call for Communication
Survey suggests now is the time for biotechs to bolster communications in a highly charged acquisition atmosphere.

TheraQuest Biosciences hired Douglas Baum as its new SVP of business development and Danny Kao as SVP of pharmaceutical development and general counsel. // Codexis named Peter Strumph SVP of commercial operations. // Avrio Biopharmaceuticals appointed David Gelber director of manufacturing. // Actelion Pharmaceuticals received the Pulmonary Hypertension Association’s 2010 Corporation of the Year award.

Jul 26–27 Bio/Pharmaceutical Summit: Optimize Market Research and to Drive Accurate Product Forecasts
Philadelphia, PA

Jul 29–30 5th Annual Congress on Clinical Supply Chain Management
Princeton, NJ

Sep 9–10 Clinical Trials in Latin America
Lima, Peru

Sep 29–30 6th Annual Bio/Pharmaceutical and Medical Device Product Recalls Summit
Washington, DC

Dec 8—9 CMAC 2010 - Commercialization and Market Access Congress
Orlando, FL

A year and a half into President Obama's tenure, how do you view the effectiveness of the "new" FDA?

Marcadia and Lilly Sign Development Deal

Former Chairman and CEO of J&J Dies at 94

Merck Challenges Verdict in Fosamax Trial

Back to the Future


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