FDA retains the right to pull a breakthrough designation if subsequent data do not back up the promise seen in early clinical results, but a few failures are not expected to unduly hurt the expedited regulatory program.
Biopharma sponsors should know that “breakthrough therapy” designation is no guarantee of success in bringing a new product or indication to market, but whether FDA will ever be willing to rescind a designation and the ramifications of such an action on the growing regulatory program are lingering questions.
A few failures of designated products to fulfill their initial promise of substantial improvements over available therapy likely will not...
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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.
An interactive look at pharma, medtech and diagnostics deals made during May 2025. Data courtesy of Biomedtracker.
Flagship Pioneering senior partner Raj Panjabi discusses shifting health care from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge.
Namrata Saroj, chief business officer of Ocular Therapeutix, is highly respected in the retina community for her contributions to drug development. She talked to In Vivo about her journey in ophthalmology, leadership philosophy and the importance of authenticity in a close-knit specialty.
