EP Vantage's report A Breakthrough Year for Unmet Diseases reveals that since the FDA's breakthrough therapy designation (BTD) was put into effect in July of 2012, pharma and biotech companies have certainly taken note.
The list of 30 disclosed BTD projects so far reveals that the vast majority have favoured big pharma and big biotech despite the FDA's promise to provide assistance on clinical trial design and guidance on development, which were aimed at the small, cash-strapped biotechs.
Key findings include:
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