A spin-off enterprise from academic labs is raising $125 million for genetically edited pigs to produce organs for human transplantation. . . . → Read More: Gene-Edited Transplant Organ Company Raises $125M
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A start-up company, spun off from a biomedical engineering lab at MIT, is raising $80 million for therapies made from synthetic circular RNA. . . . → Read More: Synthetic RNA Start-Up Gains $80M in Early Funds 
A developer of therapies using highly precise gene editing is acquiring a company delivering gene therapies identified with DNA bar codes. . . . → Read More: Gene-Editing Biotech Acquires DNA Bar Code Company 
An ALS treatment developer says the Food and Drug Administration advised the company’s clinical trial data would likely not support approval for patient use. . . . → Read More: ALS Trial Results Deemed Insufficient for FDA Approval 
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. . . . → Read More: FDA Issues Covid-19 Variant Regulatory Guidance 
Two drug makers are beginning a clinical trial to test their reformulated vaccine against Covid-19 disease, particularly among older populations. . . . → Read More: New Trial Testing Reformulated Covid-19 Vaccine 
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. . . . → Read More: Novavax Providing 1.1B Vaccine Doses to Global Group 
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. . . . → Read More: Crispr-Edited Bananas Get Industry Funding 
Global drug maker Novartis is collaborating with the Bill and Melinda Gates Foundation to find affordable gene therapies for sickle cell disease. . . . → Read More: Novartis, Gates Partner on Sickle Cell Gene Therapy 
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. . . . → Read More: 20 Precision Meds Approved by FDA in 2020  Comments are closed  Regulations  biomedical, biotechnology, FDA, genomics, life sciences, medical device, pharmaceuticals |
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