Launched to develop a better stent for treating bifurcated lesions, Stentys discovered its device appears to be effective in treating a larger unmet clinical need: acute myocardial infarction. This strategy shift holds great promise, but the company must convince physicians that its self-expanding stent will succeed where others have failed, and that it is superior to traditional stents from the major cardiovascular players.
by Stephen Levin
It is not at all uncommon for a medical device start-up company to begin by focusing on a particular clinical...
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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.
China has rapidly expanded its clinical trial footprint since 2015, driven by regulatory reforms and increased investment in pharma R&D. By 2023, it matched the US in trial volume. Oncology leads, but biologics are leading in momentum.
Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.
Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.
