Orphan Drugs- development trends and strategies

The development of pharma industries has slowed in recent years because of many reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will lose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs.

  • Cost of drug development
  • Evidence-based policy making & commissioning
  • Orphan drug status- Various Probabilities
  • Challenges in assessing clinical relevance and cost effectiveness
  • Developments in Regulating Orphan Drug Approval

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