Since the initial approval of Herceptin ten years ago, it has become the poster child for personalized medicine. But for almost as long as the drug has been on the market there have been questions about the diagnostics used with the drug and the degree to which they correlate with clinical response. Spurred by testing guidelines in 2007, there's a new-found focus on the nitty-gritty of laboratory conduct and test concordance that could serve as a useful model for addressing the broad issues of drug-diagnostic convergence.
Mark L. Ratner
It’s been a decade since the initial approval of Genentech Inc.’s breast cancer drug trastuzumab (Herceptin). Its approval was...
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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.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.
Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.
