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3D-PharmXchange congratulates MimeCure on raising €3 million to accelerate the development of its therapy for chronic lung diseases, including Idiopathic Pulmonary Fibrosis (IPF) and Chronic Obstructive Pulmonary Disease (COPD). The investment round is led by Addington Investment Group, with Apsara Investments as co-investor. The funds will support MimeCure in completing the preclinical phase and preparing continue reading…
The first patient has been dosed in the pivotal Phase 3 KHENERFIN study evaluating sonlicromanol for the treatment of m.3243A>G primary mitochondrial disease. This milestone marks an important step in Khondrion’s lead program as it advances into the registrational phase of development. Khondrion is a clinical-stage biopharmaceutical company dedicated to developing therapies for patients with primary continue reading…
Introduction As pharmaceutical drugs become physically larger, from small molecules to biologics to gene and cell therapies, so their molecular complexity increases. Small molecule drugs can be defined at the atomic level: it is known where each atom should be and how it should be connected to others. Methods are therefore developed to measure and continue reading…
We are pleased to share that the CTNNB1 Foundation has received approval to initiate a Phase I/II clinical trial evaluating URBAGEN™, the first investigational gene-replacement therapy developed for CTNNB1 syndrome. This represents a significant step forward for the CTNNB1 community, as the first therapeutic program to reach human clinical testing for this rare neurodevelopmental condition. continue reading…
We are proud to have supported TAHO Pharmaceuticals Ltd. (TAHO) in the successful submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TAH3311, the first orodispersible film formulation of apixaban. This submission marks an important milestone for TAHO and a promising advancement in the field of anticoagulant therapy. TAH3311 has continue reading…
Cellular starting material in ATMP manufacturing A challenge that many developers of ATMP products are faced with is the selection and qualification of starting material. The large diversity of ATMP products requires a tailored strategy for each product, whether you are working on an autologous or allogeneic cell product, a gene engineered product or expanded continue reading…
3D-PharmXchange is proud to be a partner in the BRECISE project (Biomarker Research and Evaluation for Clinical Implementation and Supporting Systems Enhancement), a five-year initiative co-funded by the Innovative Health Initiative (IHI) under Horizon Europe. The project brings together more than 30 public and private organizations across Europe with the shared goal of accelerating the continue reading…
3D-PharmXchange is proud to announce its collaboration with Antleron in the Living Factory 4.0 project. Antleron is a Leuven-based R&D company that develops custom bioprocess solutions for cell & gene therapy applications, with a focus on personalized and digital manufacturing. The Living Factory 4.0, supported by the CrossRoads program, aims to revolutionize the development and production of continue reading…
Introduction In our previous blog entitled ‘Biomarkers in early development‘, we highlighted the different types of biomarkers and their applications in (early) drug development. We discussed that biomarkers have the potential to speed up and enhance the chances of success of a clinical development program. A biomarker can, for example, define a patient subset most continue reading…
Introduction In my role as a consultant and in conversations with individuals who have limited experience in clinical drug development, I often find that there is some confusion between the terms “dose” and “exposure” (the plasma or local concentration of a drug). While these terms are related, they refer to distinct concepts, and understanding the continue reading…
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