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Contract manufacturing issue holds up Regenxbio’s Duchenne gene therapy trial

BioPharma Reporter

Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.

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Biopharmaceutical Contract Manufacturing: Transforming Promise into Reality

Roots Analysis

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

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Biopharmaceutical Contract Manufacturing: Transforming Promise into Reality

Roots Analysis

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

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Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

XTalks

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. As such, rare disease patients and their families often face little hope for effective treatments.

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Novartis to showcase next-gen manufacturing solutions at BIO 2024

BioPharma Reporter

Before the industry is set to arrive in San Diego for Bio International 2024, we spoke with Dr. Harald Oberegger, global head business development at Novartis Contract Manufacturing.

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Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs

pharmaphorum

An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). Tagrisso is the top-selling EGFR inhibitor, with sales of almost $3.2

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The challenges and trends of cell & gene therapies 

Drug Discovery World

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. million price point per dose.