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.
Emma Hodcroft, co-founder of Pathoplexus and a key Nextstrain contributor, stresses the importance of career flexibility for young scientists. She urges early-stage researchers to embrace curiosity, using her unconventional path as an example of how curiosity can lead to impactful success.
A German biotech has solved a fundamental physics problem that has limited mRNA therapeutics to injectable vaccines. Its breakthrough stabilizer technology allows mRNA particles to survive the mechanical stress of inhalation delivery, opening the door to treating chronic respiratory diseases.
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
