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Januvia: Defining Primary-Care Success and Risk

Januvia's fast development and successful launch exemplifies Merck's new biomarker-based R&D operation and its focused "one Merck" strategy. But the drug also provides an ideal case study of why doing everything right in primary care brings with it extraordinary risks: the key elements of Januvia's success -- blazing speed through development and the extraordinary safety profile on which its commercial triumph depends -- also define its most dangerous commercial liabilities.

By Roger Longman

Five months into its commercial life, Januvia has been the most successful anti-diabetic drug launch ever. Measured solely by returns, it could become the most successful primary-care drug ever launched--the...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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• By Eleanor Malone

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In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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• By David Wild

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