by David Cassak
Here's a quiz: How many medical device companies in the last two years have gone out in their initial public...
Kyphon: A Trial Balloon Succeeds in Spine
Until now, most spine surgeons wouldn't even treat osteoporotic fractures of the spine, referring such patients to medical management. But using technology borrowed from balloon angioplasty, Kyphon has developed instrumentation that represents a new clinical approach to this serious problem. As with most device companies, regulatory issues and reimbursement have been a challenge, as have comparisons with another spinal procedure, vertebroplasty.
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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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In Partnership with Cerba Research
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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Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy
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Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
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In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.