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Biologics articles

Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations

2026-09-02T14:51:00+01:00By Ayako Shimizu, Machiko Goto, Seiya Kobayashi and Yuki Ando

Beyond product approval: Bridging the gap between regulatory success and patient access for biosimilars

By Prasanthi Prasannakumar, Srinivas Yerraguntla, Purnima Shanmugam, Sateesh Babu GSV, Laura Guijarro, Deepti Jagga, Hao Liu, Vivek Tomar and Allison Gillespie
Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment

By Jörg Schneider, Alexia Blesius and Christian K. Schneider
Gene Therapy Medicinal Products: An examination of regulatory CMC requirements

By Srinivas Yerraguntla, Achuta Raju Samala, Rajendra Kunda, Indira Priyadarsini, Asha Balakrishnan, Sateesh Babu, Deepti Jagga, Hao Liu, Vivek Tomar and Allison Gillespie
Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU

By Ivana Turek

Managing ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
2026-09-02T10:58:00+01:00
Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
2026-06-30T14:20:00+01:00
Regulatory Rapporteur March 2026 – Contents
2026-03-06T09:18:00+00:00
The innovation era: Where biology meets technology
2026-03-05T17:58:00+00:00
Beyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
2026-03-05T14:52:00+00:00
Navigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
2026-03-04T17:04:00+00:00

Cell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
2026-03-04T15:08:00+00:00
Navigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
2026-03-04T12:15:00+00:00
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
2026-02-26T15:22:00+00:00
PS1: Tailored development of biosimilars without efficacy and safety studies – Is this the future?
2025-11-18T09:58:00+00:00
HM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development
2025-11-18T09:57:00+00:00
HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management
2025-11-18T09:55:00+00:00