Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’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

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Moffitt Researchers Identify a Mechanism Controlling Tumor Cell Recognition by Immune Cells

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

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Living Skin Can Now be 3D-Printed With Blood Vessels Included

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

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The Alliance for Regenerative Medicine Outlines Recommendations for Increasing the Number of European-Based ATMP Clinical Trials

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,

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Data suggest gene, cell therapy trial initiations in Europe lag behind North America

Medical science has moved on from the one-size-fits-all approach to the era of personalized medicine. European authorities approved the world’s first-ever gene therapy — GSK’s Strimvelis, a treatment for an inordinately rare inherited disorder characterized by a ravaged immune system, in 2016. So far, the EMA has granted the greatest number of marketing authorizations for

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Milk from Teeth: Dental Stem Cells Can Generate Milk-Producing Cells

Stem cells of the teeth can contribute to the regeneration of non-dental organs, namely mammary glands. According to a new study from researchers at the University of Zurich, dental epithelial stem cells from mice can generate mammary ducts and even milk-producing cells when transplanted into mammary glands. This could be used for post-surgery tissue regeneration

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Novartis’ Zolgensma gene therapy study halted by FDA on animal safety concerns

he Food and Drug Administration has halted a clinical trial of Novartis’ Zolgensma gene therapy due to a safety concern found in an animal study, the company said Wednesday. The hold affects the Novartis (NVS) clinical trial known as STRONG, which was testing a higher dose of Zolgensma administered by spinal injection to older children

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European Commission Approves Bavencio-Inlyta for First-line Treatment of Advanced Kidney Cancer

The European Commission (EC) has approved a combination regimen of Bavencio (avelumab) injections plus Inlyta (axitinib) tablets for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC), the most common type of kidney cancer. The combination can be used in patients regardless of their predicted prognosis and PD-L1 status. The EC’s decision followed a positive recommendation issued in September by the Committee for Medicinal

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