Reliant's business model -- building a new company to sell the primary care products that looked too puny for Big Pharma -- posed management and financing challenges that almost killed the company. It's turned around, thanks to new management and a product in a hot area-lipids. But what's really got its investors excited: the opportunities posed by late-stage primary-care failures at Big Pharmas, who are now looking for market-proven products. And those Big Pharmas can help pay the acquisition cost by dismantling the costly infrastructure created to prove the product's value in the first place.
By Roger Longman
On September 30, 2005, Ernie Mario, PhD, was doing more of what he had already done plenty of for Reliant...
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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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