How Biotech Companies Have Won a Growing Share of Oncology Drug Approvals
This white paper highlights how biotech compaines operating on lean R&D budgets have successfully produced a significant number of first-in-class compounds and $1 billion-plus drugs. Key findings include:
• FDA-approved oncology compounds all utilized at least one special regulatory mechanism, such as Fast Track designation, Orphan Drug status, or Accelerated Approval, with a majority using three or more.
• Orphan indications served as an initial market entry point to billion dollar markets.
• Innovative agents, such as those targeting receptor tyrosine kinases, achieved up to 31% approval success rates.
This white paper highlights how biotech compaines operating on lean R&D budgets have successfully produced a significant number of first-in-class compounds and $1 billion-plus drugs. Key findings include:
• FDA-approved oncology compounds all utilized at least one special regulatory mechanism, such as Fast Track designation, Orphan Drug status, or Accelerated Approval, with a majority using three or more.
• Orphan indications served as an initial market entry point to billion dollar markets.
• Innovative agents, such as those targeting receptor tyrosine kinases, achieved up to 31% approval success rates.
Deloitte Recap White Paper:
Innovative Strategies for Oncology Drug Development
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Innovative Strategies for Oncology Drug Development:
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