Trump Administration tables new version of Biosecure Act
The Trump administration has tabled a new Biosecure Act, prompting industry concern over oversight shift, regulatory uncertainty and need for stronger US biotech strategy.
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Entries by Thomas Gabrielczyk
EU committee approves New Plant Breeding (NGT) techniques
/in News/by Thomas GabrielczykOn Friday, the EU committee of Permanent Representatives of EU Member States backed the deregulation of new genomic plant breeding techniques, easing regulation for NGT1 crops.
Egetis Therapeutics AB submits rolling NDA for tiratricol
/in News/by Thomas GabrielczykEgetis Therapeutics has submitted a rolling NDA for Tiratricol to treat rare MCT8 transporter deficiency. The application for priority review is based on positive ReTRIACt study results.
FoRx raises US$50m in Series A to advance PARG inhibitor
/in News/by Thomas GabrielczykSwiss cancer specialist FoRx Therapeutics AG has secured US$50m Series A to fund Phase I development of FORX-428, supporting IND, trial execution and clinical data readout by mid-2026.
Belgian microbiome player MRM Health initiates R&D partnership in cancer immunotherapy
/in News/by Thomas GabrielczykFollowing a €55m (US$64m) Series B financing in September, Ghent-based MRM Health today announced a strategic collaboration with the research group of Professor Emile Voest, Senior Group Leader at the Netherlands Cancer Institute (NKI) and Senior Investigator at Oncode Institute.
Biopharmaceutical sector welcomes EU Biotech Act
/in News/by Thomas GabrielczykThe European Commission has unveiled the first part of its draft for a Biotech Act, focusing on health and medical biotechnology. The proposal has won strong support from industry stakeholders, who say it addresses the urgent need for faster innovation processes to retain and develop biotech in Europe.
Sobi strengthens gout pipeline with Arthrosi acquisition
/in News/by Thomas GabrielczykSobi AB has completed the US$1.5bn acquisition of Chinese Arthrosi Therapeutics Ltd. Its lead candidate, pozdeutinurad, a URAT1 inhibitor for gout, is in pivotal global Phase-III trials, with China licensing targeting approval by 2028.
Sanofi facing tolebrutinib setback in MS
/in News/by Thomas GabrielczykSanofi’s tolebrutinib fails Phase III in PPMS, while FDA postpones decision on targeted therapy approval for nrSPMS.
Eifo and Fsg back Fida Biosystems with €5m investment
/in News/by Thomas GabrielczykFida Biosystems ApS has added €5m from EIFO and FSG to an ongoing Series A financing to scale its Flow-Induced Dispersion Analysis platform, advancing in-solution biophysical analysis for drug discovery.
German pharma association publishes clinical trial ranking
/in News/by Thomas GabrielczykThe German pharmaceutical association vfa has updated its ranking of the best locations for industry-sponsored clinical trials. In Europe, Spain retained its top position in 2024, followed by Australia, Germany, the UK, and France.