European regulations might be responsible for lower numbers of advanced therapy clinical trials running in the region when compared to the US and Asia. Europe has historically been a pioneer in advanced therapies, such as cell and gene therapy. Europe was the first region to approve a gene therapy, and it boasts the highest number
Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that it has received Orphan Designations from the European Commission (EC) for paclitaxel and encequidar (“Oral Paclitaxel”) for the treatment of soft tissue sarcoma, following a positive opinion from the
Neuromuscular experts with the University of Miami Health System and the Miller School of Medicine will launch a Phase 1/2 clinical trial (NCT04146051) using the CAR-T drug, Descartes-08, to treat patients with generalized myasthenia gravis. Generalized myasthenia gravis (GMG) is a rare disease and a chronic autoimmune condition in which auto-antibodies attack specific proteins at the
In a bid to determine factors linked to the most debilitating forms of multiple sclerosis (MS), Johns Hopkins Medicine researchers say they have identified three so-called “complement system” genes that appear to play a role in MS-caused vision loss. The researchers were able to single out these genes — known to be integral in the
Purpose: The primary goal of the present study was to develop the nano-drug consisting of doxorubicin and exosome derived from mesenchymal stem cells, and to explore its effect on osteosarcoma in vitro. Methods: The exosomes were isolated from bone marrow MSCs (BM-MSCs) by an Exosome Isolation Kit. The exosome-loaded doxorubicin (Exo-Dox) was prepared by mixing
Dr. Death was a brilliant series about a rogue doctor that was unqualified at his job and made a lot of bad decisions that injured or killed many people. This terrifying tale of medical malpractice also shone a light on the problems with the medical system that could allow such an individual to bounce around from
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices. The guidance describes when a Type V drug master file (DMF) can be used to provide
Immunotherapy has become a standard treatment approach for several types of cancer, including melanoma. However, tumors can escape immune cell detection even with the use of immunotherapies. In a new study published in Cancer Immunology Research, Moffitt Cancer Center researchers, in collaboration with the University of Miami’s Miller School of Medicine, describe a cellular mechanism that controls tumor cell
Development is significant step toward skin grafts that can be integrated into patient’s skin Researchers at Rensselaer Polytechnic Institute have developed a way to 3D print living skin, complete with blood vessels. The advancement, published online today in Tissue Engineering Part A, is a significant step toward creating grafts that are more like the skin our bodies
Europe has become less competitive than other regions in attracting new ATMP clinical trials. Faster and more streamlined review processes for clinical trials by regulatory authorities are fundamental to increase clinical research and development in Europe. There is considerable country-to-country variability within Europe: the UK has the highest absolute number of new ATMP clinical trials,
