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FDA Rethinks Regulatory Approach for Next-Generation Sequencing
Amid President Barack Obama's planned Precision Medicine Initiative, the FDA is evaluating its regulatory approach to next-generation sequencing.
Amid President Barack Obama's planned Precision Medicine Initiative, the FDA is evaluating its regulatory approach to next-generation sequencing (NGS).
While most diagnostic tests fit the FDA's "one-test, one-disease paradigm" for evaluating a test's analytical and clinical performance, NGS produces a massive amount of data that might require a new approach, FDA Commissioner Margaret Hamburg writes in a blog post.
The genetic sequencing might be used to predict a person's risk of developing various conditions and might help physicians and patients determine what course of treatment.
Read more: http://bit.ly/1z7S915
Source: Fierce Health IT
Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
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Gene and Cell Therapies Hold Potential—but How Can Payers Manage Their Costs?
April 18th 2024Presenters at the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting discussed the current promise and future potential of gene and cell therapies, as well as payer management strategies for these costly treatments.
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Survival Rates in CLL: Targeted Agents vs Fludarabine Combo Therapy Study
April 17th 2024Researchers conducted an analysis of 4 phase 3 trials, covering 2751 patients, to address the potential for targeted agents in younger and physically fit patients who have chronic lymphocytic leukemia (CLL).
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