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Category: News & Comments

The Meaning of a 10-0 Vote in Favor of Novartis' CAR T-Cell Therapy Approval.

A BIG YES for Novartis CAR-T product has come from the  Food and Drug Administration (FDA) advisory committee. The committee recommended FDA approval for Novartis product CTL019 for pediatric acute lymphoblastic leukemia. The Vote : The panel voted 10-0 in favor...

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July 13, 2017

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The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion recommending marketing authorization of Alnylam’s (ALNY) RNAi product Onpattro ™ (patisiran). The product is designed to treat hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy....

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July 27, 2018

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RegenxBio product RGX-181 has been granted FDA Rare Pediatric Disease Designation for Batten Disease Condition known as CLN2

FDA Granted Rare Pediatric Disease Designation for RegenxBio's Product RGX-181 for CLN2 RegenxBio RegenxBio (RGNX) , a development-stage firm that focuses on designing and developing gene therapy based on its proprietary NAV ®  Technology Platform, announced that the U.S. FDA granted...

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February 1, 2019

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A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

The Future is Starting Now Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main...

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July 31, 2018

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Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

The United States FDA granted Breakthrough Therapy Designation to AMT-061. The European Medicines Agency gave it access to the Priority Medicine (PRIME) regulatory initiative. Gene therapy firm,  uniQure ( QURE ),  announced updated clinical data in patients treated in the...

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February 11, 2019

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Developing Another Better CAR Using NK Cells Instead of T Cells. Nektar Has Great News

IMPROVING ON CAR IMMUNOTHERAPY APPROACH   When we stated that chimeric antigen receptor CAR immunotherapy process was created to remain and improve, we aimed at demonstrating our conviction that the CAR approach will eventually be improved and become the gold...

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July 19, 2017

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Why Eli Lilly Wanted Nektar's Drug NKTR-358 So Badly. Incyte's Most Recent News

It took only a few months after the dosing stages of NKTR-358 in in a Phase I trial for Eli Lilly to strike a deal worth $400 million with the ascending firm Nektar (NKTR) related to the drug. Eli Lilly...

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July 25, 2017

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RegenxBio: An analyst and investor event focused on the firm’s ophthalmology program.

RegenxBio ( RGNX ) ,  a clinical-stage gene therapy firm with a proprietary NAV ®  Technology Platform, will host an analyst and investor event focused on its ophthalmology program;  including its lead product candidate RGX-314 , on Thursday, February 21, 2019, from 9:00...

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February 15, 2019

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Regeneron’s and Bluebird Bio’s collaboration is meant to create advanced immune cell therapy

Regeneron Pharmaceuticals (REGN) and   bluebird bio, Inc. (BLUE) announced a collaboration to apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer . The collaborators will specifically leverage Regeneron’s   VelociSuite ®  platform...

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August 9, 2018

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An Approval for Celgene and Two Breakthrough Designations for AstraZeneca

CELGENE Good news from  Celgene (CELG)  announced  that the FDA approved the firm’s targeted drug Idhifa (enasidenib) for adults with relapsed or refractory acute myeloid leukemia (AML) associated with isocitrate dehydrogenase-2 (IDH2) mutations . Good news also announced that the...

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August 2, 2017

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