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BioWorld - Tuesday, June 16, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Dec. 7, 2020

Dec. 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaite, Airehealth, Rheonix.
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Other news to note for Dec. 7, 2020

Dec. 7, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acutus Medical, Biotronik, Canary Health Technologies, DDF, Durect, Eurofins, Evonik, Seaspine, Sherlock Biosciences, Smartshape Design.
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In the clinic for Dec. 7, 2020

Dec. 7, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cerus, Precigen.
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Coronavac shipment

Brazil’s Anvisa issues emergency pathway for COVID-19 vaccines, though some firms seek other routes

Dec. 7, 2020
By Sergio Held
Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
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Regulatory actions for Dec. 7, 2020

Dec. 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling.
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Other news to note for Dec. 7, 2020

Dec. 7, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Med, Accord Healthcare, Adelia, Aeterna, Aligos, Alloy, Astellas, Aurigene, Bioxcel, Boehringer, Bridgebio, Catalent, Consilient, Cybin, Exelixis, Eyam, Genscript, Gilead, Initium, Janssen, Kalivir, Marinus, Matinas, Maze, Menarini, Merck, Moderna, Nabriva, Orexo, Orsenix, Passage Bio, Pfizer, Postera, Proxygen, Qilu, Roivant, Sellas, Seqirus, Sesen Bio, Sherlock, Sinovant, Syneos, Syros, VBI, Xencor.
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Regulatory front

BIO, PhRMA challenge MFN model

Dec. 7, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
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Erapid illustration

IQ Group Global licenses Harvard Erapid technology for inexpensive, point-of-care COVID test

Dec. 4, 2020
By Annette Boyle
Harvard University’s Wyss Institute for Biologically Inspired Engineering licensed its Erapid electrochemical sensing platform to IQ Group Global to integrate with the Australian consortium’s transistor technology in a SARS-CoV-2 test. The combined solution could greatly simplify serological testing for the virus and help monitor immunity in individuals and populations over time.
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Other news to note for Dec. 4, 2020

Dec. 4, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avinger, Australian Biotechnologies, Elixirgen, Flowmetric, Onegevity, RenalytixAI, Ricoh, Sherlock Biosciences, Shockwave Medical, Spartech, The Commons Project, Theracell, Tolo Biotech, Tufpak.
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In the clinic for Dec. 4, 2020

Dec. 4, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Apeiron, Ascletis, Clover, Cortexyme, Precision, Takeda, Sutro.
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