Clinical / R&D
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Latest From Research & Development
A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.
Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.
FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials.
Trial-related challenges in India appear to have pushed vaccine maker Bharat Biotech towards opting for alternative sites for studies on its tetravalent vaccine. The firm says it has justified its position to the regulator, though some experts advise diligence in site selection.
Plan to pursue accelerated approval carries risk that US FDA will ask for more data, which could significantly delay the launch, some analysts warn.
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