Tag: biotechnology
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FDA Issues Covid-19 Variant Regulatory Guidance
Food and Drug Administration is updating its regulatory guidance for Covid-19 drugs and diagnostics to cover emerging mutations in the SARS-CoV-2 virus.
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New Trial Testing Reformulated Covid-19 Vaccine
Two drug makers are beginning a clinical trial to test their reformulated vaccine against Covid-19 disease, particularly among older populations.
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Novavax Providing 1.1B Vaccine Doses to Global Group
Novavax, developer of a vaccine to prevent Covid-19 disease, is providing 1.1 billion doses of its vaccine for distribution to lower resource regions.
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Crispr-Edited Bananas Get Industry Funding
A popular type of banana, genetically edited to resist a soil fungus that threatens this fruit worldwide, is now backed by a major American food brand.
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Novartis, Gates Partner on Sickle Cell Gene Therapy
Global drug maker Novartis is collaborating with the Bill and Melinda Gates Foundation to find affordable gene therapies for sickle cell disease.
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20 Precision Meds Approved by FDA in 2020
A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020.
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AI Designs Better Gene Therapy Delivery Viruses
An academic-industry team used machine learning to design more effective variations of common benign viruses that deliver gene therapies.
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Immune Response Shown in Alzheimer’s Vaccine
Results from a clinical trial show an experimental vaccine produces antibodies for breaking up harmful brain deposits in people with early Alzheimer’s disease.
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AbbVie Licenses Engineered Crispr Cell Process
Drug maker AbbVie is acquiring a technology using the gene-editing process Crispr to produce new off-the-shelf engineered T-cells as disease therapies.
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FDA Clears Covid-19 Dual-Antibody Therapy
The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections.