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
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
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.
Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.
Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
During Q1, biopharmas brought in an aggregate $13.1bn in financing and device company fundraising totaled $5bn; while in vitro diagnostic firms and research tools players raised $418m.
