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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 vivomedicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.

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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. Moderna’s biological and technical expertise will be combined with core technologies of the non-viral genetic medicine platform from Generation Bio.

Genetics 130
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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. In October, the U.S.

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Astellas teams up with UK biotech Mogrify on hearing loss project

pharmaphorum

Cell therapy specialist Mogrify has struck a deal with Japanese drugmaker Astellas to look at ways to deploy regenerative medicine to treat hearing loss caused by factors such as chronic exposure to loud noises. SNHL is the most common form of hearing loss, account for more than 90% of cases and affecting millions of people worldwide.

In-Vivo 110
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The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Worldwide Clinical Trials

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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Xcell and aCGT Vector partner on cell and gene therapy development

Pharmaceutical Technology

aCGT Vector will offer its point-of-care, GMP-licensed manufacturing platform for validating Xcellbio's core next-generation manufacturing and analytical AVATAR AI technology for use in treating precision cancer. The technology is currently in late-stage beta and focused on establishing next-generation immunotherapy testing workflows.

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Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety

pharmaphorum

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

Drugs 98