A landmark political agreement has been reached by the European Commission, the European Parliament and the Council of the European Union on a comprehensive reform of the EU pharmaceutical legislation. The agreement represents the most significant overhaul of the regulatory framework in over two decades and… Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved AstraZeneca’s capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer. It is approved in cancers that have one or more abnormal PIK3CA, AKT1, or… Read More
The European Medicines Agency (EMA) human medicines committee (CHMP) made a number of key recommendations at its December 2023 meeting. Casgevy The committee recommended granting a conditional marketing authorisation for Casgevy (exagamglogene autotemcel), an advanced therapy medicinal product (ATMP) for the treatment of transfusion dependent beta-thalassemia… Read More
The EU has historically been a leader in vaccine research, development and manufacturing, but is now seeing a decline in vaccine research, according to data published by Vaccines Europe (VE). The EU has hosted approximately 20% of global vaccine clinical trials over the past two decades,… Read More
Following lengthy negotiations, the UK government has announced that the UK will be participating as a fully associated member of Horizon Europe for the remaining life of the programme to 2027. UK researchers can now apply for grants and bid to take part in projects under… Read More
The European Commission (EC) has granted conditional marketing authorisation (CMA) for Janssen’s Talvey (talquetamab) as monotherapy for relapsed and refractory multiple myeloma (RRMM). It is approved in adult patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an… Read More
DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years. The EC says the revisions will make the… Read More
New EU legislation designed to improve public health is delaying clinical trials and blocking access to new treatments for cancer and rare diseases, says the European Federation of Pharmaceutical Industries and Associations (EFPIA). The number of clinical trials delayed is expected to run into the hundreds,… Read More
Pierre Fabre will commercialise and distribute the first approved allogeneic T cell immunotherapy in Europe following the transfer of the European Commission marketing authorisation of Ebvallo (tabelecleucel) from Atara Biotherapeutics. Ebvallo is the only approved therapy for the treatment of relapsed or refractory Epstein‑Barr virus positive post‑transplant… Read More
Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. In this article, she provides her expert insights into the key regulatory developments likely to shape the global drug development industry this year. Implementation of the EU Clinical Trials… Read More
The UK government has announced its future strategy for batch testing of medicinal products. The new strategy means that the UK will continue to recognise batch testing from the EU/EEA, rather than insisting on duplicative batch testing operations. Post-BREXIT, the pharmaceutical industry urged the UK… Read More
With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. … Read More
