Moving Towards Automated Manufacturing for Cell Therapies

As more cell therapy products reach the “finish line” of U.S. Food and Drug Administration (FDA) approval and new regenerative medicine products begin the clinical development process, the need for expanded manufacturing capacity that can support long-term commercial business models is increasing. Recently, David Smith, Alex Klarer, Thomas Heathman, Courtney LeBlon, Yasuhiko Tada and Brian

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FDA and Congress Move to Stop Unproven Stem Cell Interventions

Agency’s jurisdiction over regenerative therapies upheld in landmark court ruling The Food and Drug Administration and members of Congress have taken important steps in recent months to protect consumers from unproven and risky stem cell products offered by hundreds of clinics nationwide. However, the agency needs to take broader action to deter businesses from selling

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Pfizer invests half billion dollars to advance state-of-the-art gene therapy facility in Sanford, North Carolina

Pfizer announced today an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility is anticipated to support Pfizer’s continuing investment in gene therapy research and development, similar to Pfizer’s Chapel Hill and Kit Creek, North Carolina research and development sites. This facility would

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NGen Supercluster starts with project to scale the production of treatments for cancers and rare diseases

iVexSol’s project will tackle the cost and shortages of these treatments through high-volume production solution Source Innovation, Science and Economic Development Canada Through the Innovation Superclusters Initiative, the Government of Canada is taking immediate and targeted action to build on Canada’s existing strengths to help our companies and their workers get ahead in the global

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Precision Medicine Trials and Molecular Testing Guidelines Expand to Reach More Patients

The Lung Cancer Master Protocol (Lung-MAP), a large precision medicine umbrella trial supported by the National Cancer Institute (NCI) and their partners, has opened the trial to include advanced-stage patients with all non–small cell lung cancers (NSCLCs). To accommodate these new trial patients, the NCI has also made further changes to the trial’s protocol.  The

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Gene Therapy Market Research Explores The Key Success Factors And Business Opportunities Including Key Players Forecast Till 2026

Source Transparency Market Research Gene Therapy Market – Snapshot The global gene therapy market is expanding at an exponential pace due to promising therapeutic outcomes of gene therapy, high prevalence and rise in incidence of cancer, and large number of clinical research pipeline products. In terms of revenue, the market was valued at US$ 17.0

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Now Available: ARM’s Searchable, Downloadable Database of Near-Term Anticipated RM/AT Data Readouts and Other Clinical Events

This new resource provides clear, simplified information on indication-, technology-, or company-specific upcoming data readouts and other clinical events. ARM has carefully curated all entries to ensure they fall within our narrowly defined criteria for regenerative medicines, and includes many milestones which are not reported in other clinical trial datasets, including anticipated product approvals. Currently, the database includes 188 anticipated events and includes a search-and-download function, and

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Researchers turn plastic water bottles into prosthetic limbs

Artificial limbs made out of plastic water bottles could save healthcare providers millions of pounds and help tackle pollution at the same time. An expert at De Montfort University Leicester (DMU) has successfully manufactured the first-of-its-kind prosthetic limb socket made from recycled plastic bottles. Dr K Kandan, senior lecturer in Mechanical Engineering at DMU, found he could

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