10 December 2024
10 December 2024
An improved price discount and new evidence from Santhera has changed NICE’s tune following a recommendation rejection earlier this year.
Developed alongside AstraZeneca, the breakthrough designation comes following early pooled results from two ongoing trials finding the drug was well tolerated.
Novartis Venture Fund, Johnson & Johnson Innovation – JJDC and Forbion co-led the funding round.
The PDUFA date for the potential new indication is set for 7 May 2025.
A live biotherapeutic, SER-155 secured fast track status from the FDA in December 2023.
The $16.5bn acquisition agreement was first announced in February 2024.
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