Clinical / R&D
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Latest From Research & Development
The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.
US FDA's advisors want data from three animal models – not just the cotton rats that Janssen was hoping for – before candidate vaccines are tested in healthy infants.
Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.
US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.
Former Obama Administration official offers sophisticated and complicated approach to value-based pricing, tied back to drug development costs. The complexity alone makes the idea a non-starter for the current Administration, but it also begs the question of whether it would be more likely to cut costs – or just increase R&D spending?
Interview With J&J’s CMO Dr Joanne Waldstreicher On Internal And External Challenges To Sharing Clinical Trial Data
"Everything different and worthwhile comes with its challenges," Johnson & Johnson’s chief medical officer, Joanne Waldstreicher, told the Pink Sheet's Sukaina Virji in an interview about how the company went about engaging in initiatives to share its clinical trial data and make drugs available for compassionate use.
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