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Today, we look at what happened during yesterday’s FDA advisory panel review of exa-cel, and a recently reintroduced bill that would support tax incentives for biofuels with more accurate measures of carbon reduction. (452 words, 2 minutes, 15 seconds) |
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FDA panel greenlights approval of first human drug using CRISPR |
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Food and Drug Administration (FDA) advisers cleared the way for the first FDA approval of a human drug using CRISPR technology.
The news: FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said exa-cel, the sickle cell gene therapy developed by BIO members Vertex Pharmaceuticals and CRISPR Therapeutics, is safe for clinical use.
Safe and effective: Yesterday’s advisory committee meeting followed the FDA’s assertion Friday that the drug is effective, helping 29 of 30 patients stay pain-free for 18 months.
Why it matters: The therapy offers relief and a possible cure for sickle cell disease. By year’s end, exa-cel could become the first FDA-approved drug using CRISPR, opening the door for a medical revolution in gene-edited therapies—and cures.
What they’re saying: “We are finally at a spot where we can envision broadly available cures for sickle cell disease,” Dr. John Tisdale, a member of the advisory committee, told The New York Times.
What’s next: The FDA is scheduled to decide on approval of exa-cel on Dec. 8. Another gene therapy for sickle cell disease, developed by BIO member bluebird bio, is scheduled for FDA review on Dec. 20. |
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While growing up, like many, Valentin Busch, Co-Founder of Elastrin Therapeutics, struggled with mental health challenges and chronic disease. But this sparked his passion for leveraging science and technology to improve the human condition. He describes his company's groundbreaking work to remove blood vessel calcification and restore elastin, which could potentially save millions of lives from cardiovascular diseases.
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GREET Act seeks accurate measure of how well biofuels cut GHGs |
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Sens. John Thune (R-SD) and Amy Klobuchar (D-MN) recently reintroduced a bill to support tax incentives for biofuels with more accurate measures of carbon reduction.
The GREET Act would require the Environmental Protection Agency (EPA) to use the gold-standard Argonne National Laboratory’s GREET methodology when assessing carbon reductions achieved by biofuels.
Why it matters: The Inflation Reduction Act (IRA) provides performance-based tax incentives to encourage the blending and production of sustainable aviation fuels and other biofuels. But EPA’s 13-year-old methodology does not accurately measure carbon reductions from biotech innovations.
Why it’s better: The Argonne methodology, embraced by the Department of Energy, is recognized as a global leader in assessing the full life cycle carbon reductions of producing biofuels. It accurately measures reduced carbon emissions from agricultural improvements, including greater production per acre and reduced fertilizer use.
BIO supports the GREET Act and the Argonne methodology as a member of the SAF Blender Tax Credit Coalition.
BIO’s view: “Older lifecycle models fail to recognize technological advances in farming and biofuels, leading to woeful omissions in recognizing how modern-day practices are leading the way in lowering GHG emissions by 44-52% compared to standard petroleum-based gasoline,” said John Torres, BIO’s Director of Federal Government Relations for Agriculture & Environment. Read more on Bio.News. |
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