Biologics | Pharmaceuticals | Regulatory Rapporteur

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Biologics articles

Considerations for generics developers moving into the field of biosimilars

2025-01-10T08:49:00+00:00By Asha Kattige and Zeb Younes

Small interfering RNA: regulatory challenges and therapeutic potential
2024-10-11T10:25:00+01:00
Introduction to cannabinoids: understanding UK regulation, structure, industry dynamics and charting the future
2024-09-13T12:16:00+01:00
Botanicals and digestive enzymes demonstrate the complexity and diversity of food supplement regulations in the European Union
2024-09-13T12:14:00+01:00
Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU
2024-05-08T10:30:00+01:00
The first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
2024-05-08T10:30:00+01:00
Near-term challenges of advanced therapy medicinal products: a maturing product class
2024-05-08T10:00:00+01:00

Dr Peter Marks on reflecting innovation through FDA regulation
2024-05-08T08:30:00+01:00
The increasing complexity of biological medicinal products
2024-01-05T00:05:00+00:00
A weight of evidence approach for the non-clinical evaluation of complex biologicals
2024-01-05T00:05:00+00:00
Navigating early drug development investment: a detailed guide to due diligence
2024-01-05T00:05:00+00:00
Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
2024-01-05T00:05:00+00:00
Innovating and harmonising access and requirements amid the global regulatory challenges of biologics
2024-01-05T00:05:00+00:00