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Yearly Archives: 2020

The European Commission (EC) approved Novartis Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease

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Jan 20, 2020: The European Commission (EC) approved Novartis Mayzent® (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active...

Chimeric antigen receptor T cell(CAR-T cell)

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Chimeric antigen receptor T cells (also known as CAR T cells) are T-cells that have been genetically engineered in order to produce an artificial  T-cells receptor for...

Clinical studies and FDA approvals CAR-T therapies

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CAR-T Cell therapy is developed using the patient's own T-Cells which are part of the body immune system and play a central role in...

AstraZeneca’s Imfinzi and tremelimumab granted Orphan Drug Designation in the US for the treatment of hepatocellular carcinoma

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Jan 20,2020: AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine,both have been granted Orphan Drug Designation (ODD) in US for the treatment...

How CAR-T cells work in treating Cancers

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CAR-T cells are genetically engineered in order to express chimeric antigen receptors specially directed toward antigens on a patient's tumour cells and then infused...

Structure of Chimeric Antigen Receptors

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Chimeric antigen receptors combine numerous facets of normal T cell activation into a single protein. They link an extracellular antigen recognition domain to an intracellular signalling domain, which...

Heroic-Faith Medical Science expects US FDA clearance for AI-powered respiratory monitor

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Jan 20, 2020: Heroic-Faith Medical Science expects its AI-powered respiratory monitor in order to receive US FDA clearance this year, according to Taiwan-based startup....

Drug Approval Process in China

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The National Medical Products Administration (NMPA) ( Chinese name translation in English “State Drug Administration” or China Food and Drug Administration CFDA)  and the...

Evolution of CAR design & Construction

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In 1989, first CAR-T cells were developed by Gideon Gross and Zelig Eshhar at Weizmann Institute, Israel. The complexity of the engineered CAR receptors has evolved over time,...

WuXi Biologics and Bayer jointly Enter into an Acquisition Agreement on a Drug Product Plant in Germany

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Jan 16, 2020: WuXi Biologics and Bayer jointly announced an acquisition agreement that WuXi Biologics Germany GmbH will take over the operations of one...

TG Therapeutics Initiates Rolling Submission of NDA to U.S. FDA for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or...

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Jan. 16, 2020: TG Therapeutics, Inc. announced that the Company has been initiating a rolling submission of a New Drug Application (NDA) to the U.S. FDA...

FDA Grants Fast Track Designation to Arena Pharmaceuticals’ APD418 for Development for the treatment Decompensated Heart Failure Patients

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Jan. 16, 2020:  Arena Pharmaceuticals, Inc. announced that the U.S. FDA granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in...
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