By Michael McCaughan
All the experts agree: 2006 should be a much better year for new drug approvals than 2005. And it better...
The drug approval drought keeps getting worse. FDA says it approved 20 new products during the year, one of the lowest totals in two decades. In fact, focusing on genuinely innovative medicines, the total was even worse. The good news is that 2006 should be a much better year. But focusing on 2006 misses the point: it's the long-term trend that matters. The hope for a turnaround relies on some leaps of faith. Industry is gambling that advances in drug development science will pay off-even though the first efforts to reap the fruits of the genomics revolution are one reason for the current drought.
By Michael McCaughan
All the experts agree: 2006 should be a much better year for new drug approvals than 2005. And it better...
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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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Many assets do not meet their pre-launch predictions, either exceeding or falling short of their forecast sales. In this article, In Vivo highlights several historic examples and the factors that influenced their unexpected performance.