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www.prnewswire.com/news-releases/global-gene-therapy-technologies-markets...

The markets for gene therapy have been difficult to estimate as there only a few approved gene therapy products Gene therapy markets are estimated for the years 2019-2029.

www.globenewswire.com/news-release/2019/08/02/1896456/0/en/The-Global-Gene...

Approved gene therapy products in the global market. Number of gene therapy products to gain FDA approval by 2024. Market value of the forthcoming gene therapy products. Leading gene therapy startups.

www.washingtonpost.com/business/economy/the-fda-approves-a-gene-therapy-that...

The Food and Drug Administration on Friday approved the most expensive drug in the world, a $2.1 million one-time gene therapy for treatment of a rare disease that afflicts infants.

www.sciencedirect.com/science/article/abs/pii/S0734975019302022

Consequently, this review summarizes the gene therapy drugs approved worldwide from 1998 to 2019 in details, including names, indications, dates of approval, companies, vectors, the applied technologies and mechanisms of gene therapy drugs, etc. Furthermore, the gene therapy drugs were classified and addressed in accordance with the employed ...

www.liebertpub.com/doi/abs/10.1089/humc.2018.201

The EMA withdrew the authorization for two tissue engineering products, one cell therapy and one gene therapy, and New Zealand lapsed approval of one cell therapy. Most products were first authorized after 2010, including 10 (83.3%) gene therapies, 13 (72.2%) cell therapies, and 13 (56.5%) tissue-engineered products.

www.genengnews.com/.../bright-outlook-for-the-global-cell-and-gene-therapy-market

The regulatory approval process, particularly in the United States, is evolving and becoming favorable for vendors for developing cell and gene therapy products.

www.nuventra.com/resources/blog/fda-promotes-cell-and-gene-therapies

FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Biologics Evaluation and Research (CBER) Peter Marks, M.D., Ph.D., released a joint statement on January 15, 2019 previewing new FDA policies to advance the development of safe and effective cell and gene therapies.. This statement comes amid expectations for record numbers of Investigational New Drug (IND) applications and ...

www.biopharma-reporter.com/Article/2020/01/31/FDA-guidance-on-gene-therapies...

With more than 900 investigational new drug (IND) applications for ongoing clinical studies related to gene therapies, and with the number of advanced therapy medicinal products at clinical stage worldwide exceeding 1,000 , the US Food and Drug Administration (FDA) this week released a number of policies.. The policies, addressed to developers and manufacturers, include six final guidance ...

www.medpagetoday.com/special-reports/exclusives/84956

With two chimeric antigen receptor (CAR) T-cell treatments and two more traditional gene therapies approved, plus a handful of gene therapy products in late-stage trials, excitement is high.

cdn.ymaws.com/www.casss.org/resource/resmgr/cell&gene_therapy/2018_CGTP_Gavin...

CASSS Cell and Gene Therapy Workshop. Regulatory Updates from Across the Globe. July 11, 2018. Regulatory Updates for Human Gene Therapy Products: An FDA Perspective Denise Gavin, PhD. Chief, Gene Therapy Branch. Division of Cellular and Gene Therapies. Office of Tissues and Advanced Therapies. Center for Biologics Evaluation and Research