By Tom Salemi
Changing Minds at the FDA
Visioncare's recent success in getting an FDA advisory panel to change a recommendation is a rare and noteworthy achievement. But the agency could prove to be an even more formidable barrier - and a potential catalyst for change - for the device sector going forward.
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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In Partnership with Cerba Research
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
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AI-related deal activitiy in the first quarter of 2025 was punctuated by a last-minute $600m raise for Isomorphic Labs.
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The process of manufacturing medicines can often be complex, expensive and harmful to the environment. Initiatives like RESILIENCE UK are seeking to simplify this process, utilizing VR technology to create a more sustainable learning environment for both students and companies.
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Lundbeck CEO Charl van Zyl spoke with In Vivo about the Danish company’s multipronged transformation, one that involves a rethink of company culture, pipeline strategy and a sharpened focus on innovation in rare neurological disorders.