FDA Grants Approval For First At-Home Chlamydia, Gonorrhea Test
Those infections are the two most common STIs in the U.S. Among other news, Amazon has removed seven eye-drop products from sale after the FDA warned they were unapproved. Also: the CDC has updated advice for preventing and treating anthrax.
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At-Home Test For Chlamydia, Gonorrhea Cleared By FDA For 1st Time
The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country. (Branswell, 11/15)
In other pharmaceutical news —
The Washington Post:
Amazon Removes 7 Eye Drop Products After FDA Warning
Amazon is removing seven eye-drop products from its e-commerce site after the Food and Drug Administration warned the company that the products were unapproved, the company announced Wednesday. The FDA listed these products: Similasan Pink Eye Relief; The Goodbye Company Pink Eye; Can-C Eye Drops; Optique 1 Eye Drops; OcluMed Eye Drops; TRP Natural Eye Floaters Relief;
Manzanilla Sophia Chamomile Herbal Eye Drops. (Mark, 11/15)
CIDRAP:
CDC Updates Advice For Preventing, Treating Anthrax
The updates to the 2014 guidelines on naturally occurring anthrax, published today in Morbidity and Mortality Weekly Report, include an expanded list of alternative antimicrobial drugs to use if first-line drugs are contraindicated, not tolerated, depleted, or ineffective after a bioterroristic release of aerosolized B anthracis or a multidrug-resistant genetically engineered strain of the bacterium. (Van Beusekom, 11/15)
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World's First CRISPR-Based Medicine Wins Approval In U.K.
Regulators in the U.K. on Thursday approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new phase of genetic medicine. (Joseph, 11/16)
Bloomberg:
Wegovy: Novo Nordisk Staff Get Free Drug As A Perk If They Need It
If you’re a Novo Nordisk A/S employee with obesity, you will have access to a unique company perk: Free Wegovy. Novo offers to reimburse staff who have been prescribed the expensive weight-loss drug by a doctor in its homeland Denmark, the company said by email. The perk, which is still taxable, is also available to employees diagnosed with conditions that other Novo drugs treat, such as diabetes and hemophilia. (Wass, 11/15)
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Astellas Still Sees Hope In Its Gene Therapy After Four Deaths
A gene therapy study, halted when four children with a rare neuromuscular disorder died after treatment, showed enough promise to merit finding a path forward, according to the medicine’s manufacturer. The treatment, made by the Japanese pharmaceutical company Astellas, led to severe and fatal liver problems for four of the 24 treated children with X-linked myotubular myopathy, or XLMTM, a genetic disease that severely degrades muscle function and kills most patients before the age of 10. (Garde, 11/15)
Also —
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FDA Reorg Will Put New Emphasis On Investigations, Sources Say
There’s about to be a new acronym in town. The Food and Drug Administration is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products, according to three people familiar with the planning. That overhaul includes a new name: Meet the Office of Inspections and Investigations. (Owermohle, 11/15)
Stat:
More Drug, Device Patents Invalidated For Bad Info Than Those Filed By Other Industries
The patents on medicines and devices approved by the U.S. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis. (Silverman, 11/15)
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FDA Cancer Chief On How To Get Things Done: ‘Don’t Tell Anybody'
The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many. (Wilkerson, 11/15)
