ARIAD Pharmaceuticals, Inc.
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Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.
Soon-to-start digital transformation initiatives at the major Japanese pharma firm will focus on in-housing of IT systems and company-wide enhancement of AI/data analytics skills.
Looking to treat patients with CSU uncontrolled by Xolair, Celldex’s KIT binder barzolvolimab shows strong disease activity reduction at 12 weeks in Phase II. Sanofi’s BTK inhibitor rilzabrutinib also showed efficacy in CSU.
In its 2023 report on global R&D trends for the biopharma sector, IQVIA found a shrinking percentage of deals involving $5bn+ revenue companies; R&D spending among big pharmas is the highest since 2014.
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