Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease. The final guidance is a revision of a policy ...

Optimizing Drug Packaging: Strategic Approaches for De-Risking Drug Development ...

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new ...

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat ...

Synaffix, a Lonza company, has licensed its ADC technology to BigHat Biosciences to be combined with the latter's ML design platform to develop new ADCs ...

The system is Hapman’s first major product launch since 2008, following a year of intensive R&D that builds upon the company’s eight decades of tubular drag conveyor expertise. Rather than relying on ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property ...