ARM's Statement on the EU's Health Technology Assessment Guideline
Alliance for Regenerative Medicine
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1M ago
The EU Health Technology Assessment (HTA) Coordination Group’s ‘Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons’ is discouraging news for rare disease patients and the Advanced Therapy Medicinal Products (ATMP) sector ..read more
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ARM welcomes the release of the Center for Medicare and Medicaid Innovation’s (CMMI) Cell and Gene Therapy Access Model
Alliance for Regenerative Medicine
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2M ago
The voluntary model recognizes that transformative, durable, and potentially curative gene therapies require innovative thinking about access, payment, and healthcare delivery ..read more
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The Alliance for Regenerative Medicine Announces Election of 2024 Board of Directors
Alliance for Regenerative Medicine
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7M ago
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New Analysis by Tufts’ NEWDIGS Shows that Durable Cell and Gene Therapies Have Substantially Higher Clinical Success Rates than Other Treatments
Alliance for Regenerative Medicine
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7M ago
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Alliance for Regenerative Medicine Promotes Michael Lehmicke to Senior Vice President, Science & Industry Affairs
Alliance for Regenerative Medicine
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9M ago
The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the engineered cell therapy and genetic medicines sector, announced the promotion of Michael Lehmicke to Senior Vice President, Science & Industry Affairs, effective immediately ..read more
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Proposed joint clinical assessment methodology would have rejected nearly 90% of the ATMPs currently authorized in the EU
Alliance for Regenerative Medicine
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11M ago
Without changes recognizing the unique characteristics of ATMPs, the EU’s new Joint Clinical Assessment will fail to deliver the next generation of transformative therapies to rare disease patients, according to the Alliance for Regenerative Medicine, EveryLife Foundation for Rare Diseases, and Rare Diseases International ..read more
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ARM Releases Statement on MVP Act Re-Introduction
Alliance for Regenerative Medicine
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1y ago
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Patients will benefit if Europe modernizes its policy framework to reflect the distinct promise of cell and gene therapy, the Alliance for Regenerative Medicine will highlight in 29 November EU Parliament event
Alliance for Regenerative Medicine
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1y ago
The European Union can reverse its declining competitiveness and ensure patient access to transformative treatments if it modernizes its policy and regulatory framework to reflect the distinct promise of cell and gene therapies as the future of medicine, the Alliance for Regenerative Medicine (ARM) will say during an event at the EU Parliament on 29 November ..read more
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Statement on European Commission's Proposed 'Substance of Human Origin' Regulation
Alliance for Regenerative Medicine
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1y ago
The European Commission’s proposed ‘Substances of Human Origin’ (SoHO) Regulation holds the promise of improving patient safety while establishing greater legal and regulatory certainty across the EU ..read more
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ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing
Alliance for Regenerative Medicine
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1y ago
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) today released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case study of a Chimeric Antigen Receptor T-cell (CAR-T) therapy ..read more
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