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More news on the mifepristone case—plus, one patient’s journey with vitiligo (and a promising new drug) and debunking myths about GMO foods. (686 words, 3 minutes, 25 seconds) |
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Appeals court partially blocks mifepristone ruling |
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A ruling to limit patient access by undermining Food and Drug Administration (FDA) approval of the drug mifepristone was partially suspended late yesterday.
The latest decision: The 5th Circuit Court of Appeals’ suspension means the FDA’s 2000 approval of mifepristone stands, and the drug can be distributed during the appeal. But subsequent FDA decisions to expand access, including allowing mailing of the drug, remain blocked, USA Today reports.
BIO urged suspension in an amicus brief on Tuesday. The brief said blocking FDA approval of a drug “would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development.”
Why it matters: Patients and the biotech industry rely on science-based decisions by the FDA to ensure access to medications, says BIO.
A court undermining the FDA “has consequences that extend well beyond the single drug, and stokes regulatory uncertainty in an industry responsible for bringing life-saving and life-enhancing therapies to vulnerable patient populations,” said BIO President and CEO Rachel King. |
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A patient’s story: New therapy proves to be a good match for vitiligo |
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Investigations into potential uses of an autoimmune therapy led to a breakthrough in treating vitiligo, according to a patient who explains her journey in Bio.News.
What’s vitiligo? A previously untreatable condition causing patches of skin to lose pigment. Now recognized as a chronic immune disorder, vitiligo affects as many as 2.8 million in the U.S.
Patient journey: Clary Estes writes in Bio.News about her experience with ineffective treatments before recently learning of Opzelura, a drug based on ruxolitinib, a Janus kinase (JAK) inhibitor targeting the immune system. Incyte developed Opzelura while exploring uses for ruxolitinib just as researchers were linking vitiligo to autoimmunity.
Following science: “This is one of those really nice examples of when you follow the science and find that it takes you along this certain path, in this case vitiligo, then you are really able to make a difference for patients,” says Incyte VP Jonathan Dickinson.
The journey continues: While professionals and patients are hailing the benefits of Opzelura as the first treatment showing efficacy, and approval is expected soon in Europe, there is more to do. “Drugs like Opzelura signify a leap in the treatment of vitiligo, not a finish line,” writes Estes. Read her story in Bio.News. More Health News: Fortune: A zombie apocalypse isn’t likely–but a fungal outbreak is
“Every day, more fungi develop resistance to the current arsenal of treatments. And without effective drugs to combat these infections–many of which can be deadly–it’s only a matter of time before we experience a significant outbreak of a fungal or other microbial infection,” writes David Angulo, M.D., an infectious disease specialist and president and CEO of the biotechnology company SCYNEXIS. |
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Read Chubb’s Report on Industry Risks
| Chubb, BIO’s preferred provider for insurance and risk management, and the National Center for Middle Market (NCMM) released a must-read report for life science executives. Key findings for middle-market life science companies include continued supply chain and workforce concerns and the expansion of risk into other areas of the business.
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Fact-checking a false GMO food claim |
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USA Today debunked a false claim about the risks of genetically modified food, with assistance from the Missouri Biotechnology Association (MOBIO).
The claim: A March 29 Instagram post (direct link, archive link) shows a supposed news release about testimony in the Missouri House of Representatives captioned “GMO food like the type Bill Gates is pushing to manufacture in factories WILL alter your genetics,” USA Today said.
The facts: The claim is false, and the testimony was not presented in the Missouri House.
The Missouri House witnesses included MOBIO Executive Director Kelly Gillespie, who told the hearing and newspaper that science shows the safety of gene-edited and genetically modified foods. MOBIO is a member of the Council of State Bioscience Associations (CSBA).
Food can’t transfer genes: “No methods presently exist in which food consumption or non-invasive methods can be used to deliver gene therapy,” Kelly explained, citing the FDA.
Knowledgeable consumers understand gene-edited and genetically modified foods are safe, a study shows. |
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President Biden’s Thursday: Meeting President Michael Higgins of Ireland and young participants in Gaelic sports as his trip to Ireland continues. It has been a chance to get in touch with his heritage, The New York Times reports.
What’s Happening on Capitol Hill: Recess. Meanwhile, the Senate Health, Education, Labor, and Pensions (HELP) Committee has reportedly pushed back mark-up of drug pricing policies originally scheduled for next week; the committee says they need more “technical assistance.” |
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