All posts by PIER MARIA FORNASARI

FDA approves Sarepta’s 2nd Duchenne drug

The FDA unexpectedly reversed course Thursday, approving the second treatment developed by Sarepta Therapeutics for the rare disease Duchenne muscular dystrophy just a few months after rejecting the drug.  Sarepta announced Thursday evening that the agency had approved its second drug, called Vyondys 53. After the drug was originally rejected by the FDA in August due to concerns over the

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Prellis Biologics launches TissueWorkshop™ to accelerate human tissue engineering research

TissueWorkshop™ makes complex tissue engineering simple for all researchers by generating complex 3D scaffolds that can be printed with any 3D printer Prellis Biologics, Inc. has developed an intuitive web-based interface tailored for biologists and tissue engineers that can be learned in minutes. TissueWorkshop™ takes a set of user inputs and applies generative design principles to produce

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European Commission publishes new documents regarding the Clinical Trials Regulation

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form. 2. Recruitment and Informed consent procedure template This draft template was developed

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Extracellular matrix hydrogel derived from decellularized tissues enables endodermal organoid culture

Organoids have extensive therapeutic potential and are increasingly opening up new avenues within regenerative medicine. Source Nature Communications Their clinical application is greatly limited by the lack of effective GMP-compliant systems for organoid expansion in culture. Here, it’s envisaged that the use of extracellular matrix (ECM) hydrogels derived from decellularized tissues (DT) can provide an

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Fresh red blood cell transfusions do not help critically ill children better than older cells

Findings from the ABC-PICU study may alter policies at hospitals where fresh red cells are preferentially used A new study led by the Sainte-Justine University Hospital Centre and the University of Montreal, and Washington University School of Medicine in St. Louis has found that transfusions using fresh red blood cells—cells that have spent seven days

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A transient wave of hematopoietic stem cell production discovered in late fetuses and young adults

Hematopoietic stem cells (HSCs) are responsible for the constant replenishment of all blood cells throughout life. One of the major challenges in regenerative medicine is to produce tailor-made HSCs to replace the defective ones in patients suffering from blood related diseases. This would circumvent the shortage of donor HSCs available for the clinic. To achieve

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New mechanism contributing to adult bone maintenance and repair

Led by researchers at Baylor College of Medicine, a study published in the journal Cell Stem Cell reveals a new mechanism that contributes to adult bone maintenance and repair and opens the possibility of developing therapeutic strategies for improving bone healing. “Adult bone repair relies on the activation of bone stem cells, which still remain poorly characterized,”

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