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Amid Zolgensma crisis, Novartis gets a gene therapy boost as NICE embraces Luxturna
biospectrumasia
September 08, 2019
In December 2017, Luxturna became the first directly administered gene therapy approved in the U.S. Now, it’s recommended for use on the NHS in England.
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Pfizer adds $500M to gene therapy manufacturing plant where it will hire 300 workers
fiercepharma
August 22, 2019
Pfizer, which is in a race with competitors for its initial gene therapies, is shifting its production efforts into overdrive. The company will inject another $500 million into a manufacturing plant in North Carolina and says it will hire another 300 work
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With 'remarkable' data, Biogen's Spinraza sharpens its case against Novartis gene therapy
fiercepharma
July 04, 2019
Biogen credited spinal muscular atrophy (SMA) drug Spinraza as its main growth driver last year, and the company aims to keep it that way—even in the face of new competition from Novartis gene therapy Zolgensma.
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BioMarin Announces Valoctocogene Roxaparvovec Gene Therapy Study in Severe Hemophilia A Met Pre-Specified Criteria
americanpharmaceuticalreview
May 29, 2019
BioMarin Pharmaceutical announced its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A achieved pre-specified clinical criteria for regulatory review in the U.S. and Europe.
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Novartis’ gene therapy Zolgensma gets FDA sign-off
pharmaceutical-technology
May 29, 2019
Novartis subsidiary AveXis has received approval from the US Food and Drug Administration (FDA) for Zolgensma to treat children with spinal muscular atrophy (SMA).
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Novartis reveals promising interim Phase 3 data for gene therapy Zolgensma in spinal muscular atrophy
pharmafile
April 23, 2019
Novartis has revealed new interim data from its Phase 3 trial investigating the efficacy of its gene therapy Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101) in the treatment...
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Catalent to acquire gene therapy leader Paragon Bioservices
cphi-online
April 18, 2019
Catalent to acquire gene therapy leader Paragon Bioservices
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Catalent pulls off $1.2B deal for gene therapy CDMO Paragon Bioservices
fiercepharma
April 16, 2019
In the second major buyout of a gene therapy manufacturer in the last three weeks, Catalent snapped up Paragon Bioservices in a $1.2 billion deal.
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First gene therapy recommended for approval in the EU for TDT
pharmaceutical-technology
April 03, 2019
US-based therapeutics developer bluebird bio has secured positive recommendation from a European Medicines Agency (EMA) panel for the approval of its first gene therapy Zynteglo to treat certain patients with transfusion-dependent β-thalassemia (TDT).
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AveXis expands world-leading gene therapy manufacturing capacity with purchase of advanced biologics therapy manufacturing campus in Longmont, Colorado
firstwordpharma
April 02, 2019
AveXis, a Novartis company, today announced it signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont……