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  • Supreme Court to Weigh in on Fraud Standard under False Claims Act

    In a move that may substantially increase healthtech companies' exposure to monetary damages, the U.S. Supreme Court agreed to weigh in on the key standard for fraud lawsuits under the False Claims Act (“FCA”).  On January 13, 2023, the Supreme Court granted petitions for writs of certiorari in two now-combined 7th Circuit Court whistleblower fraud lawsuits that address the fraud standard– ...
  • BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

    Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda.  According to BioNTech's press release, the modular factory consists of six ISO-sized shipping containers that will arrive in Rwanda sometime in early 2023.  Reports indicate that the modular units were manufactured i ...
  • Cochlear Implant Developer Agrees to Pay for Alleged False Claims to FDA

    Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced.  The allegations were in connection with information provided within pre-market approval (PMA) applications to the FDA for cochlear implant processors, as reported by a DOJ press release dated Decemb ...
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