The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic ...

To have any impact, patient engagement needs to start with the drug development pathway, not at the point of licensing. That’s especially true in the rare disease space, where the unmet need is ...

Cell membrane proteins hide secret gateways that can be used to modify cell behavior. This has been demonstrated in a study ...

The RMAT pathway (formerly called regenerative advanced therapy, or RAT) is analogous to the breakthrough designation designed for traditional drug candidates and medical devices. Specifically, it ...

Pharma needs to be mindful of all customers along the drug development pathway, from the outset, through the subsequent trials and regulatory processes, and on to delivery. Market research (MR ...

The co-development of molecular markers ... correlates of the clinical efficacy of a novel drug by studying the target, its pathway and other related molecules, it might become possible to use ...

repurposed drug candidates that could reach patients sooner than traditional drug development pathways. About SOLVE FSHD SOLVE FSHD is a venture philanthropic organization established to catalyze ...

Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.

integrating technology expertise to optimise the drug development pathway. With a proposition of combining science with technology, we integrate Artificial Intelligence (AI) and automation ...

The drug "hijacks" a normal developmental pathway to trigger cancer cell death ... retinoic acid signaling in the same way as ...