US Regulatory Trends During 2010: A Rapidly Changing Environment
Published: 25 Jan 2011
- 28 pages
- PDF delivery via email, hard copies via first-class mail
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Product Description
Business Monitor International (BMI)'s special report `US Regulatory Trends During 2010: A Rapidly Changing Environment' highlights the challenges and opportunities for drugs approved, rejected and withdrawn in 2010.
Drawing on BMI's pharmaceutical and healthcare expertise, the report analyses the competitive landscape for major drugmakers in a rapidly changing environment.
Key Findings
- Only 21 new drugs were approved by the US FDA in 2010, the lowest number since 2007 when just 18 new drugs were approved.
- The pharmaceutical industry has shown it is still launching high-value, innovative medicines, albeit at a slower rate than in the previous decade, despite industry-wide criticism and declining investor confidence.
- Five potential blockbusters were approved during 2010, highlighting promising revenue growth opportunities for Genentech, NovoNordisk, Amgen, Novartis and Dendreon. Most of the new drugs approved are biological therapies, including Prolia (denosumab), Actemra (tocilizumab) and Provenge (sipuleucel-T).
- Approval figures for 2010 reflect a tougher regulatory environment. The increasing emphasis on safety has led to several delays into 2011 or beyond for the completion of reviews for marketing authorisation applications of highly anticipated products.
- 2010 was marked by a number of high profile marketing authorisation withdrawals: GlaxoSmithKline's Avandia (rosiglitazone), Abbott Laboratories' Meridia (sibutramine) and Roche's Avastin (bevacizumab).