Heart valve replacement and repair has long been the exclusive province of surgeons. The percutaneous heart valve sector, including both aortic and mitral, has been among the hottest device areas for investors and entrepreneurs over the past few years. CoreValve was founded b a surgeon who is using his understanding of valve anatomy to develop a percutaneous aortic valve replacement (PAVR) device that can be used by interventional cardiologists.
by Stephen Levin
One can easily understand if cardiac surgeon Jacques Seguin, MD, PhD, has a hard time getting his fellow heart surgeons...
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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.
Industry is trying to side-step President Trump’s tariff- and price-curbing policy proposals. It may do better facing up to enduring R&D productivity and drug affordability challenges.
UK pharma faces a critical turning point as the Economic Crime and Corporate Transparency Act introduces the "Failure to Prevent Fraud" offense in September 2025, requiring companies to transform their approach to fraud prevention or face severe consequences.
Kura Oncology's new chief medical officer discusses her path to leadership, the company's advancing AML pipeline, and her methodical approach to developing treatments for underserved oncology indications.
