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The European Commission has launched a public consultation to support the development of the European Biotech Act, which is now being prioritised after a previous delay. The Commission plans to publish the legislative proposal by the end of 2025 and is inviting stakeholders across the biotechnology sector to provide feedback on regulatory, financial, and operational barriers.
Italian biotech company ReiThera srl has commenced safety trials of its experimental HIV vaccine candidate, GRAdHIVNE1, in Harare, Zimbabwe. Developed in partnership with the Ragon Institute at Harvard University, this innovative HIV vaccine targets conserved regions of the viral gag, env, and pol genes to stimulate a robust cytotoxic T-cell immune response.
Initial clinical data indicate that the recombinant cysteine protease imlifidase, developed by Hansa Biopharma AB, may significantly reduce levels of anti-AAV antibodies, potentially enabling adeno-associated virus (AAV)-based gene therapies in patients previously deemed ineligible due to pre-existing immunity.
US President Donald Trump has set a deadline in a letter to the CEOs of the 17 leading Big Pharma companies for the announced reduction of prescription drug prices.
Following Merck Sharp & Dohme (MSD)’s US$10bn acquisition of Verona Pharma and its potential COPD blockbuster Ohtuvayre®, GlaxoSmithKline (GSK) has secured a US$12bn deal for another PDE3/PDE4 inhibitor.
LIfT BioSciences Ltd, active in London, Galway and Houston, has been awarded a grant of €12m from the Disruptive Technologies Innovation Fund (DTIF) to support the clinical translation of its Immuno-Modulatory Alpha Neutrophils (IMANs). This funding will enable the preparation of the world’s first allogeneic therapy using synthetically programmed neutrophil granulocytes for Phase I trials.
In the ongoing dispute over US import tariffs on European pharmaceuticals, the European Commission has acquiesced to a 15% tariff on EU pharmaceutical exports to the United States, as well as to the imposition of the same rate on EU investments exceeding US$600m in the US, without formal resistance. Industry associations have reacted with strong criticism.
The potential blockbuster HER2 tyrosine kinase inhibitor sevabertinib, developed jointly by Bayer AG and the Broad Institute, is expected to be submitted for regulatory approval in China in Q3 2025 for the treatment of HER2-positive non-small cell lung cancer (NSCLC).
The British Food Standards Agency (FSA) has formally accepted an application by French start-up Gourmey SAS for regulatory approval of its cultivated foie gras, a product developed using cellular agriculture techniques. The submission was initially lodged on 26 July 2024 and was made in parallel across five jurisdictions: the European Union, United States, Singapore, Switzerland, and the United Kingdom.
As part of the green transformation of North Rhine-Westphalia’s former coal-mining region, independent assessors have recommended the co-financing of two biotechnology processes developed at pilot scale by Evonik Industries AG, with the aim of advancing them to demonstration scale. The third funding round of the “Produktives.NRW” call includes approximately €70 million from the EU’s Just Transition Fund (JTF) allocated to six projects.