Pharma must adjust rapidly to a new regulatory world dominated by FDA’s new drug safety authority. Post-marketing risk management plans are likely to be the key to surviving in the new climate. But beware: they change the relationship of pharma companies to doctors and patients. And they also drastically change the nature of pre-approval filings to FDA.
Cole Werble
There is a new regulatory acronym, REMS, that everyone in the pharma business needs to learn and understand. Risk Evaluation...
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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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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.
In this episode, In Vivo speaks with Micha Breakstone, co-founder and CEO of Somite.AI, and Samantha Dale Strasser, VP of strategy, to explore how their techbio is applying foundation models to human cell differentiation.
In a busy year for US biosimilars, 2025 saw more than a dozen approvals as multiple biologics faced competition for the first time – including Stelara. However, concerns persist over the lack of rivals in development for numerous brands coming off-patent, with a hope that regulatory streamlining can
Corporate venture arms can be powerful growth partners, but founders who don’t take time to understand them risk missing their greatest value.
