Anocca AB has secured the first regulatory authorization in Europe for a CRISPR-Cas gene-edited T-cell receptor T-cell therapy trial, with the phase I/II study now due to start over the next three months at sites in Sweden, Germany, Denmark and the Netherlands.
French biotech Pep-Therapy SAS is in the midst of raising a €20 million (US$21.62 million) round and, at the same time, prospecting for potential partners after winning FDA orphan drug designation for its bifunctional peptide Pep-010 in the treatment of pancreatic cancer. Pep-010 currently is moving to the conclusion of a phase Ib trial and the new money will fund phase II development.
The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
A survey of members of the Bioindustry Innovation Organization (BIO) has exposed what is at stake for the sector, on both sides of the Atlantic, if proposed tariffs are imposed on pharmaceutical imports to the U.S. "A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the EU,” according to BIO.
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
Eight months after announcing the $18.5 million first tranche of its series A, Augustine Therapeutics has closed the oversubscribed round at $85 million and is now ready to begin clinical development of its novel histone deacetylase-6 (HDAC6) inhibitors.
The obesity market is driving pharma’s return on investment (ROI) upward, with the projected return rising to 5.9% overall in 2024, but only reaching 3.8% if GLP-1 assets are excluded. At the same time, the average cost of developing a drug continues to rise and now stands at $2.23 billion, compared to $2.12 billion in 2023, according to Deloitte’s 15th annual analysis of the ROI from pharmaceutical innovation.
Science ministers from 13 countries in Europe are calling on the European Union to offer a home to researchers affected by the Trump Administration’s cuts. They have written to EU research and innovation commissioner Ekaterina Zaharieva asking her to organize a welcome “for brilliant talents from abroad who might suffer from research interference and ill-motivated and brutal funding cuts.”
