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Siga Technologies, HHS sign $113M procurement deal for smallpox, mpox treatment
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German court lifts lower court injunction on sale of NanoString products
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Lab exec turned aviator hit with $26.3 million default judgment
By LabPulse.com staff writers
Compounding his troubles, the court held him in civil contempt for violating an order that prohibited him from selling his house without approval from the court.
July 26, 2024
Gavel Money Social
FDA releases final guidance on use of real-world data in regulatory submissions
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) released its final guidance on using real-world data in regulatory submissions, detailing how drug companies should assess data from electronic health records and medical claims to support their applications.
July 25, 2024
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Siga Technologies, HHS sign $113M procurement deal for smallpox, mpox treatment
By LabPulse.com staff writers
Biotech company Siga Technologies announced that the U.S. Department of Health and Human Services (HHS) exercised a procurement option on an existing contract with Siga to deliver approximately $113 million of the firm's oral antiviral treatment TPoxx.
July 22, 2024
3 D Monkeypox Infecting Cell Social
German court lifts lower court injunction on sale of NanoString products
By LabPulse.com staff writers
In the latest development of the ongoing litigation between Bruker and 10x Genomics, a court injunction suspending sales of Bruker subsidiary NanoString's CosMx Spatial Molecular Imager products in Germany has been lifted.
July 19, 2024
Law Books Gavel Social
Vertex sues HHS for Casgevy fertility program access
By LabPulse.com staff writers
Vertex Pharmaceuticals filed a lawsuit against the U.S. Department of Health and Human Services seeking to be permitted to offer its fertility support services program to Medicaid patients who have been prescribed its Casgevy gene-editing treatment.
July 16, 2024
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Five committee recommendations for clinical laboratory testing and biomarker analysis
By Liz Carey
Lawmakers take aim at FDA LDT regulation, over-the-counter (OTC) diagnostic test pipelines, medication safety in pregnant women, pharmacogenomic safety issues, and novel biomarkers.
July 17, 2024
Capitol Hill Government Social
FDA issues alert on BD vial supply shortage
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) is warning of a shortage of Becton Dickinson (BD) vials used to diagnose bacterial and fungal infections, suggesting that providers prioritize their use for patients with suspected bloodstream infections.
July 15, 2024
Lab Vacutainer Test Tube Social
Cambridge researchers create predictive model for Alzheimer's disease
By LabPulse.com staff writers
Researchers at Cambridge University have developed an artificial intelligence (AI) model that is effective at predicting if patients who show early dementia symptoms will remain stable or develop Alzheimer's.
July 15, 2024
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Researchers discover new class of guide RNA for genome editing
By Liz Carey
Bridge RNA recombination may lead to precise gene insertions at specific sites across the genome beyond single-gene disruption and open new pathways for understanding how genes influence health and disease.
July 10, 2024
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Clinical laboratory testing implicated in national healthcare fraud sting
By Liz Carey
A look at seven federal healthcare fraud cases rooted in COVID testing, cancer genetic testing, pharmacogenomic (PGx) testing, cardiovascular genetic testing, and telemedicine.
July 10, 2024
Legal Scales Social
New assay developed for persistent African HIV strains
By LabPulse.com staff writers
A multinational research team has developed a test to measure the persistence of HIV in people who have been infected by strains of the virus found predominantly in Africa, providing a necessary tool in the search for a cure for HIV.
July 9, 2024
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Gene therapy for bladder cancer enters clinics
By Liz Carey
A novel gene therapy designed to treat unresponsive nonmuscle invasive bladder cancer is making its way into clinics.
July 9, 2024
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