Tag Archive for: Clinical trials

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

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Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support expedited development and review Ladenburg, Germany, 23 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), […]

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Ona Therapeutics Appoints Oncology Drug Development Veteran Dr. Antoine Yver as Chair to Accelerate ADC Programs to Clinical Inflection Points

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Brings over 35 years of oncology drug development experience, including senior executive leadership roles at AstraZeneca and Daiichi Sankyo Led the development and approval of multiple breakthrough medicines such as ENHERTU®, TAGRISSO®, and LYNPARZA® Strengthens Ona’s transition to a clinical-stage company with ONA-255, while advancing its pipeline of first-in-class ADCs targeting major solid tumors Barcelona, […]

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Xeltis announces positive data for Xabg, its coronary artery bypass conduit, in EU clinical trial

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Preliminary clinical data from Xabg, Xeltis’ coronary artery bypass conduit (CABG), demonstrating positive safety and patency  In an earlier, separate trial, Xabg recently demonstrated patency with excellent flow in a 24-month trial – the first time ever this duration has been achieved Supports potential of Xabg to transform CABG surgery landscape and eliminate need for […]

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One Biosciences Announces €15 Million Series A Financing to Advance Clinical Single Cell Profiling

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Funding will be used to establish the clinical utility of OneMap™, a proprietary artificial intelligence (AI) driven single cell transcriptomic oncology platform, to guide treatment decisions, patient selection, therapy development, and optimize clinical trials Proceeds will also help scale strategic partnerships with pharmaceutical and biotechnology companies Financing led by Redmile Group and Blast, with participation […]

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This week’s hot topic: Why Pharma will have to play the long game on Alzheimer’s drugs

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By Stephen Adams, Optimum Strategic Communications Few people expected England and Wales’s drugs spending watchdog, the National Institute for Health and Care Excellence (“NICE”), to approve Eli Lilly’s new dementia drug donanemab for use on the NHS last week.  At a reputed annual cost of at least £60,000 a year, including the care bill, it […]

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