Category REGENERATIVE MEDICINE

Relaxing of regulations for regenerative medicines has cascading effect internationally

Countries that relax regulations for regenerative medicines could be causing a downward spiral in international standards, according to new research published today. Researchers warn that if just one country decides to relax regulations in the field, a heightened sense of competition can spur others to do the same. It’s unclear whether this deregulation best serves

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New nanotechnology could aid stem cell transplantation research

Nanotechnology developed at Rutgers University-New Brunswick could boost research on stem cell transplantation, which may help people with Alzheimer’s disease, Parkinson’s disease, other neurodegenerative diseases and central nervous system injuries. The nanotechnology platform, which uses special tiny rods for sensing, allows researchers to confirm the identity of human stem cell fates and their biomarkers, or

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PTPσ inhibitors promote hematopoietic stem cell regeneration

Receptor type protein tyrosine phosphatase-sigma (PTPσ) is primarily expressed by adult neurons and regulates neural regeneration. Researchers at UCLA recently discovered that PTPσ is also expressed by hematopoietic stem cells (HSCs) and describe small molecule inhibitors of PTPσ that promote HSC regeneration in vivo. Systemic administration of the PTPσ inhibitor, DJ001, or its analog, to

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Novartis violated FDA’s sacred principle: In God we trust, all others must bring data. Robert Califf opinion

Source STAT A common saying at the Food and Drug Administration is: “In God we trust, all others must bring data.” The independent evaluation of science is an essential element of the FDA’s dual role of protecting the public health and promoting innovation to bring new therapies into practice. In fact, with certain exceptions, the

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Cambridge scientists reverse aging process in rat brain stem cells

New research reveals how increasing brain stiffness as we age causes brain stem cell dysfunction, and demonstrates new ways to reverse older stem cells to a younger, healthier state.  New research, published today in Nature, reveals how increasing brain stiffness as we age causes brain stem cell dysfunction, and demonstrates new ways to reverse older stem

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Novartis ousted top scientists over manipulation of data for gene therapy

Source STAT Novartis dismissed the top two scientists at its gene therapy division shortly after CEO Vas Narasimhan learned of internal data falsification that has since snowballed into a damaging scandal, a person familiar with the situation said Wednesday. The company previously said it was “in the process of exiting” scientists who were responsible for

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An emerging view of RNA transcription and splicing

P.M. Fornasari 08/10/2019 Whitehead Institute scientists find chemical modification contributes to trafficking between non-membrane-bound compartments that control gene expression. Cells often create compartments to control important biological functions. The nucleus is a prime example; surrounded by a membrane, it houses the genome. Yet cells also harbor enclosures that are not membrane-bound and more transient, like

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ICER closely monitoring FDA’s Zolgensma investigation

Following an announcement by the FDA that it is investigating ‘data manipulation’ of Novartis’ Zolgensma, the Institute for Clinical and Economic Review (ICER) has commented that this could lead to a re-evaluation of its initial cost-effectiveness assessment of the drug.   Novartis’ gene therapy Zolgensma was approved by the FDA to treat spinal muscular atrophy (SMA) in children under two

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