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March 27, 2020

COVID-19 roundup: Gilead declines orphan designation for potential treatment

Daily Briefing

    Hackensack Meridian expands access to its rapid diagnostic tool, Mylan waives U.S. distribution rights for potential COVID-19 treatment, and more.

    COVID-19 weekly webinar: What health care leaders need to know

    • Gilead Sciences has asked FDA to rescind its orphan drug designation for remdesivir, a medication that is being tested to treat COVID-19. The move comes after consumer advocates criticized Gilead for pursuing a monopoly for the medicine. The designation would have allowed Gilead to block lower-cost generic versions of the drug for seven years. Researchers said results of clinical trials for remdesivir are due soon (Silverman, STAT News, 3/25; Lupkin, "Shots," NPR, 3/25).

    • Johns Hopkins Medicine is using digital health startup Emocha's telehealth tool to make contact with doctors, nurses, and other clinical staff who were potentially exposed to COVID-19. Emocha uses the tool to monitor health care workers for symptoms through video visits and treatment tracking forms. Sebastian Seiguer, CEO of Emocha, said the tool is critical given limited access to COVID-19 tests (Reuter, MedCity News, 3/24).

    • Hackensack Meridian Health's Center for Discovery and Innovation on Tuesday announced a licensing agreement that would make its COVID-19 diagnostic tool available to other health systems. The rapid COVID-19 test, which was developed on March 12, will be added to T2 Biosystems' in vitro diagnostics platform, which is currently being used by hundreds of hospitals across the country. Test results will be available within three to five hours (Park, Becker's Health IT, 3/24).

    • Mylan on Wednesday announced that it waived exclusive U.S. distribution rights for its generic version of Kaletra, an HIV treatment that is being tested as a potential therapy for COVID-19. The move would allow other drugmakers to seek approval for their generic versions of the drug in order to increase supply. Mylan said waiving the distribution rights will help researchers determine if the drug is effective in treating COVID-19 (Joseph, Reuters, 3/25).

    • Novartis on Thursday announced it is teaming up with 15 life sciences companies to combat COVID-19. The companies said they would share their libraries of compounds to increase development and delivery of vaccines, diagnostic tests, and treatments for the disease. Novartis said successful treatments could move to clinical trials in as soon as two months (Koltrowitz, Reuters, 3/26).

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