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Latest From PAION AG
A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold.
Are three FDA clinical holds in less than four days a symptom of lax safety programs at some biotech companies? And what does the latest publication on Aduhelm say about the relationship between safety and accelerated approval?
Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.
The US biotech has presented interesting preliminary data from the first four patients treated in the Phase I/II STAAR study evaluating isaralgagene civaparvovec for Fabry.
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- CeNeS Pharmaceuticals plc.