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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Why demand is rising for secure and climate-controlled gene therapy services

Pharmaceutical Technology

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone.

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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S. About VTX-801.

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J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

Carvykti’s approval was based on data from the Phase III CARTITUDE-4 study that showed earlier use of Carvykti cut the risk of disease progression or death by 59 percent compared to standard therapy combinations in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.