Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
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To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
Proposed US tariffs on pharmaceutical imports could disrupt global supply chains, drive up production costs, and exacerbate drug shortages. How will the industry respond?
Ahead of the Critical Medicines Act anticipated in 2025, Teva’s report offers policy recommendations to mitigate the economic pressures risking generic medicine availability in Europe.
As a significant water consumer to enable production of high-quality medicines, this demand brings both challenges and opportunities for the pharmaceutical industry up to 2033, research suggests.
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
Under growing global competition, this development highlights potential challenges for the UK to uphold large-scale pharmaceutical investments.
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.