Archives: 2019-06-05

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.  “Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” said Eric Bastings, M.D., deputy director of the

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Researchers Recognize Transformative Power of 3D Printed Pharmaceuticals

Authors Ghadge Snehal, Aloorkar Nagesh, and Sudake Suresh from the Satara College of Pharmacy explore 3D printing of medication, and the possibilities for the future in ‘A Decisive Overview on Three Dimensional Printing in Pharmaceuticals.’ The researchers realize the enormous impact 3D printing is having worldwide, offering truly infinite power for innovation—with a tremendous focus on the

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‘Organs in a dish’ pave the way for personalized medicine in gut and liver disease

Source Elsevier One of the most exciting advancements in stem cell research has been the development of organoid systems, which are organ-like three-dimensional structures that mimic their corresponding organ in vivo. In this important review in Digestive and Liver Disease, published by Elsevier, scientists highlight some of the established and exciting novel uses for organoids or

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Cell Therapy : Reviews and Industry News at June the 4th 2019

Reviews Gene Editing for Immune Cell Therapies Autologous T cells that have been genetically modified to express a chimeric antigen receptor targeting the B cell antigen CD19 have yielded remarkable clinical responses in patients with B cell malignancies, and are now on the market as anticancer ‘drugs’. [Nat Biotechnol] Abstract The Next Generation of CRISPR-Cas Technologies

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A 3-D printer powered by machine vision and artificial intelligence

MIT startup Inkbit is overcoming traditional constraints to 3-D printing by giving its machines “eyes and brains.” Objects made with 3-D printing can be lighter, stronger, and more complex than those produced through traditional manufacturing methods. But several technical challenges must be overcome before 3-D printing transforms the production of most devices. Commercially available printers

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bluebird bio Announces EU Conditional Marketing Authorization for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia Who Do Not Have β0/β0 Genotype

ZYNTEGLO is the first gene therapy approved for transfusion-dependent β-thalassemia (TDT) European marketing authorization for ZYNTEGLO follows the fastest assessment of an advanced therapy medicinal product (ATMP) as part of the European Medicines Agency’s Priority Medicines (PRIME) program ZYNTEGLO is bluebird bio’s first gene therapy to gain regulatory approval bluebird bio, Inc. announced today that the European Commission (EC)

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