David Lederman started Abiomed 25 years ago to develop an artificial heart, the AbioCor. While the AbioCor development continues, a new management team has broadened the company's focus. Where Abiomed once pioneered heart replacement, they now are breaking new ground in heart recovery. The challenge is whether, armed with new products and clinical data, the company can change physicians' treatment patterns for acute heart failure patients.
By Stephen Levin
Many entrepreneurs launch device companies with a dream of developing a new medical technology that will revolutionize a therapeutic area...
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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.
As president of US Hematology at J&J, June Lanoue's leadership approach focuses on improving patient outcomes and organizational development. Her career path demonstrates the role of curiosity and adaptability in health care advancement.
Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”
While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.
