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Editas, changing course again, looks to partner lead CRISPR therapy

Bio Pharma Dive

The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.

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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.

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Ginkgo Bioworks partners with WARF for new GD2 CAR T-cell therapies

Pharmaceutical Technology

WARF is the patenting and licensing organisation for the University of Wisconsin–Madison in the US. All the new GD2 CAR designs developed through the partnership will be validated via in vitro screens and in vivo murine models. Topic sponsors are not involved in the creation of editorial content.

In-Vivo 264
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Moderna and Generation Bio partner for genetic medicines development

Pharmaceutical Technology

Moderna has entered a strategic partnership with Generation Bio for the development of non-viral genetic medicines. The collaboration aims to expand each company’s platform application through the development of new nucleic acid therapeutics, and to expedite their respective non-viral genetic medicines pipelines.

Genetics 130
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FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The regulatory agency carried out the review of the Biologics License Application (BLA) for the therapy under the Priority Review approach. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects.

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Xcell and aCGT Vector partner on cell and gene therapy development

Pharmaceutical Technology

Pharmaceutical companies Xcell Biosciences (Xcellbio) and aCGT Vector have partnered to expedite the development of cell and gene therapies. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.

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Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

Earlier in the year, the company had announced a move towards developing treatments for hemoglobinopathies like sickle cell disease and beta thalassemia and a focus on in vivo discovery. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. g/dL and 45.4%