By Melanie Senior
One of the industry's hottest topics, biosimilars, will be at the top of the list this fall for executives at...
Biosimilars: EMEA Wants Approvals
European regulators’ guidelines on biosimilars show that they are serious about quickly approving cheaper follow-on biologics. The hurdles may come thereafter.
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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.
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In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company’s ambitious pipeline and strategic direction.
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Lonza is addressing the growing global demand for biologics by utilizing its expert teams and the advanced capabilities of its newly acquired large-scale manufacturing site in Vacaville, California. Joanna McCafferty, Director of Commercial Development, shares more in this brief video. Ask ChatG
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Understand who’s influencing access decisions and how pharma can engage strategically across the continent.