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Sanofi-Aventis' Zimulti: Knowing When to Say When

 
• By Kate Rawson

Rimonabant had all the early signs of a mega-blockbuster. But behind that shiny veneer was a drug with a serious risk profile-one that mimicked the suicidality rates of the SSRI class. That made rimonabant an enormous red flag for FDA reviewers. Why didn't Sanofi-Aventis see it coming?

By Kate Rawson

By the time the advisory committee meeting rolled around for Sanofi-Aventis’ rimonabant (Zimulti), there wasn’t much the company could do to convince the Food & Drug Administration

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• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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