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BioWorld - Friday, July 18, 2025
Home » Topics » Infection » Coronavirus

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Shipping container with flag of China

Beijing export officials using black, whitelists to determine exportability of test kits

June 10, 2020
By Mark McCarty
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
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Regulatory front for June 10, 2020

June 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed.
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Regulatory actions for June 10, 2020

June 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Illumina, Quidel.
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Other news to note for June 10, 2020

June 10, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AACC, Akadeum, Calmare Therapeutics, Cota, Curadigm, Healgen, Helixbind, Hematogenix, Huma, Menarini Silicon Biosystems, Nanobiotix, Nanocellect, Neuspera, Orasure Technologies, Roche, Tyto Care, Vivera Pharmaceuticals.
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U.S. Capitol building

Senator: Now’s the time to plan for next pandemic

June 10, 2020
By Mari Serebrov
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed.
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Gloved hand holding COVID-19 vaccine vial, syringe

BIO Digital: COVID-19 vaccines outlook offers reasons for hope, concern

June 10, 2020
By Michael Fitzhugh
Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first.
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India posts draft rules for compassionate use of unapproved drugs

June 10, 2020
By David Ho
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
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Regulatory actions for June 9, 2020

June 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4web Medical, Atomic Blue, Dexcom, Hangzhou Biotest Biotech, Incelldx, Seasun Biomaterials, Sekisui Diagnostics, Vasoptic Medical.
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Regulatory actions for June 10, 2020

June 10, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bacainn, Curis, F2G, Fulcrum, Pharnext, Redhill, Rezolute, Vertex.
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Other news to note for June 10, 2020

June 10, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagene, Adgero, Alligator, Alphamab, Aptevo, Autotelic, Biocryst, Bryn, Bryologyx, Curadigm, Debiopharm, Delmar, Denali, Dyadic, E-therapeutics, Intomics, Izana, J&J, L.E.A.F., Lyvgen, Mateon, Melinta, Menarini, Merck, Metuchen, Midatech, Mitsubishi Tanabe, Nanobiotix, Nantkwest, Neurotrope, Orgenesis, Ose, Panacea, Pharmabcine, Qualigen, Refana, Secura, Stemline, Supernus, Takeda, Tetraphase, US Worldmeds, Zealand.
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