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Imfinzi plus Imjudo approved in EU for advanced cancers
Hepatocellular carcinoma and non-small cell lung cancer patients are set to benefit from the recent approval of Imfinzi plus Imjudo combinations in the EU.
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The European Commission (EC)
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Therapeutic-first for cold agglutinin disease haemolytic anaemia
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
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EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
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Sharing data on human tissue availability across EU
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
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Evusheld COVID-19 therapy approved in EU
Evusheld becomes first and only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
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First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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EU regulators release new workplan for accelerating clinical research
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
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The EU HTA regulation: a new frontier for access to innovative technologies
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
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Monkeypox update – August 2022
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
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EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
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Developing a holistic approach to cardio, metabolic and renal disease
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
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Global Blood Therapeutics: driving innovation in sickle cell disease
Sebastian Stachowiak, Head of Europe & GCC at Global Blood Therapeutics (GBT), explains how, while the company establishes its presence in Europe, it continues its commitment to advance the care of people living with sickle cell disease by collaborating with the sickle cell community to develop breakthrough therapies, raise awareness…
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Healthier Together and philanthropic ventures in tropical disease
Europe launches the EU Non-communicable diseases (NCDs) initiative, while GSK and Novartis promise millions to support drug R&D for neglected tropical diseases and malaria.
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2022 spells change for EU pharmaceutical legislation
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
