FDA confidence to devote time and resources for a breakthrough product resonates with investors and analysts, but the real program value in terms of product sales is yet to be seen. Sponsors also must be careful to manage investor expectations once the breakthrough designation is secured.
Analysts and investors seem to be taking FDA at its word when it comes to the promise of a breakthrough product, but those promising therapies also will have to see long-term success for the program to be validated.
There is little commercial evidence so far, and the first wave of products didn’t necessarily have the full range of benefit from the program, as many of the designations came...
Big pharma plans to invest billions of dollars in US manufacturing to avoid tariffs proposed by the Trump Administration. However, the implementation of these plans may be delayed due to regulatory complexities and rising costs from tariffs, potentially impacting drug prices for consumers.
The process of manufacturing medicines can often be complex, expensive and harmful to the environment. Initiatives like RESILIENCE UK are seeking to simplify this process, utilizing VR technology to create a more sustainable learning environment for both students and companies.
Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.
The Centre for Commercialization of Regenerative Medicine has spent over a decade crafting a cell and gene therapy ecosystem in Canada. Now it is replicating the model abroad.
Almost halfway through 2025, and financing for European biotech could be described as challenging. Market volatility, geopolitical instability and trade barriers all loom large in biotech CEO minds when pitching for funding. In Vivo talked to biotechs and investors to gain a realistic view of the current market for company funding so far this year.
From chemical engineering to cancer innovation, AbbVie's rising oncology leader is advancing next-generation ADCs to tackle difficult-to-treat tumors with a patient-centered approach.
Mini-profiles of five synthetic biology companies and their leaders from SynBioBeta 2025 reveal how AI integration, data-driven platforms and interdisciplinary teams are revolutionizing drug discovery and manufacturing.
