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Regulatory Roundup: News & Publications in Pharma and Biotech, August 2026
How will the revised pharmaceutical regulation change the EMA’s Priority Medicines (PRIME) scheme?
In this blog, we explore the current PRIME framework, examine how the revised pharmaceutical legislation may impact the scheme, and discuss what…
How will the revised pharmaceutical legislation change orphan-designated medicines for rare diseases?
In this blog, we explore the current EU orphan designation framework, examine the proposed legislative changes, and discuss the potential…
Regulatory Roundup: News & Publications in Pharma and Biotech, July 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation.
What are the challenges with Project Optimus?
While the goals of Project Optimus have been widely welcomed, its implementation has also raised important questions for medicine developers,…
Project Optimus: Why does the oncology dosing paradigm need to change?
Introduction The emergence of targeted therapies, biologics and immunotherapies has transformed the oncology treatment landscape, raising important questions about whether…
Regulatory Roundup: News & Publications in Pharma and Biotech, June 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this…
What is Project Optimus, and what problem is it trying to solve in oncology dosing?
The Food and Drug Administration (FDA) launched Project Optimus, an initiative to establish a dose-optimisation paradigm for cancer therapies. The…
Regulatory Roundup: News & Publications in Pharma and Biotech in May 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this…
Regulatory Roundup: News & Publications in Pharma and Biotech in April 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this…
Regulatory Roundup: News & Publications in Pharma and Biotech in March 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this…
Regulatory Roundup: News & Publications in Pharma and Biotech in February 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this…