SHANGHAI - China's National Development and Reform Commission has released long-awaited price cuts that will mostly affect multinational pharma companies
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
