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Clinical / R&D

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Latest From Research & Development

Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

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.

Research & Development Regulation

RSV Vaccines Need Multiple Animal Models Before Infant Testing, Panel Says

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.

Advisory Committees Vaccines

FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says

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.

Drug Approval Standards Neurology

Autism Feedback To FDA: Focus On Communication, Redefine 'Irritability'

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.

Drug Approval Standards FDA

Taking Big Pharma’s R&D Argument Literally: Cut Prices, Or Increase Spending?

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?

Pricing Debate Medicare

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.

Clinical Trials Research & Development
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