Qui tam litigation holds a dear place in the hearts of U.S. federal prosecutors and whistleblowers alike, but the volume of these cases ebbed as the COVID-19 pandemic swept across the nation. A report by Gibson, Dunn & Crutcher LLP makes clear, however, that despite the pandemic-induced drag, these cases are resuming their historical pace, and makers of drugs and devices are once again the most frequently targeted type of business.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August.
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.
Much of the research on the immune response in patients with COVID-19 has focused on the humoral antibody response. Adaptive Biotechnologies Corp., on the other hand, has focused on cellular immunity to measure the T-cell response to infection with SARS-CoV-2.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
With the economy and public health on the line, U.S. President Donald Trump thumped his Made in America pulpit again Thursday on a campaign swing through Ohio, in which he vowed to bring the pharmaceutical supply chain home over the next four years.
Senseonics Holdings Inc. is one of the latest med-tech companies to release its quarterly numbers, revealing sales of $261,000, a decline of -94.3% year-over-year. That figure may have fallen below SVB Leerink Research’s estimate of $1.6 million and consensus at $1.4 million “given the company's well-telegraphed ongoing strategic review,” wrote Danielle Antalffy in a note. Still, Senseonics had some good news, which Antalffy heralded as “very positive.” That came in the form of a financial and strategic partnership with Ascensia Diabetes Care that revolves around a global commercialization and distribution agreement and a concurrent financing deal.
The Medical Device Innovation Consortium (MDIC) has worked diligently to stand up the National Evaluation System for health Technologies (NEST) as a functioning program, and the first iteration, known of course as NEST 1.0, is now up and running.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
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