Robotics, or computer-enhanced surgery, still has its skeptics. But a small group of start-up device companies are pushing forward, claiming that they represent a radically new--and better--way to do surgery. The dilemma for the small companies: to sell the concept behind robotics while, at the same time, competitively positioning their individual offerings.
by David Cassak
Real revolutions happen in stages. The French Revolution, after all, produced first despotism (Napoleon), then a constitutional monarchy (Louis XVIII)...
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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.
