US FDA AdComm For Vertex’s Sickle Cell Gene Therapy ‘Not A Concern’
The US biotech revealed the US Food and Drug Administration would be holding an advisory committee meeting for exa-cel during its second quarter earnings, but analysts are unfazed by the news amid robust revenues and raised guidance.
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The two sides of the US public’s perceptions of the biopharma industry are likely to dominate the headlines this fall. Will the industry emerge defined by innovation and hope for better health? Or by massive profits protected by litigation?
The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.
Positive tandem ICER reviews for bluebird bio’s and Vertex/CRISPR’s gene therapies show the impact that concerns about addressing racial inequities could create a favorable context for products as they enter pricing and coverage discussions.