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BioWorld - Wednesday, January 20, 2021
Home » Topics » Infection » Coronavirus

Coronavirus
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Free access to BioWorld coronavirus articles

Last updated: Jan. 19, 2021
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The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are constantly updated:

Vaccines and therapeutics in development

Diagnostics on the market and in development

Clinical trials of biopharma products affected by COVID-19


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Australia map, flag

Stakeholder survey: Drug and device companies laud TGA’s pandemic response but want process improvements

Last updated: Jan. 19, 2021
By Tamra Sami
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PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
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Other news to note for Jan. 19, 2021

Last updated: Jan. 19, 2021
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alithya Group, Applied DNA Sciences, Applied Stemcell, Artms, Bardy Diagnostics, Cardialen, Cogme, Cue Health, Diaceutics, Electrocore, Guardant Health, Gns Healthcare, Hamilton Storage, Helius Medical Technologies, Hillrom, Integrated DNA Technologies, Intersect ENT, Isotopia Molecular Imaging, Mayo Clinic Laboratories, Menon Biosensors, Mindup, Neovasc, Physiq, Qiagen, Rhinostics, Sensorion, Serotiny, Twist Bioscience, Vivos.
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Drug pricing illustration

Pandemic puts pressure on drug sales

Last updated: Jan. 19, 2021
By Brian Orelli
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The 39th Annual J.P. Morgan Healthcare Conference was sans Celgene Corp.'s annual tradition of kicking off the conference with preliminary revenue and earnings from the previous year, but plenty of other companies stepped up and offered preliminary results of their own. Unfortunately, some companies continued to face headwinds selling drugs during the pandemic as patients avoided their doctors' offices.
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Woman gets COVID-19 vaccine in Brazil
Vaccination started in minutes

Brazil approves Coronavac and Covishield COVID-19 vaccines, turns Sputnik V back

Last updated: Jan. 19, 2021
By Sergio Held
No Comments
CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford.
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Regulatory front for Jan. 19, 2021

Last updated: Jan. 19, 2021
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Jan. 19, 2021

Last updated: Jan. 19, 2021
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bioinvent, C4, Dr. Reddy's, Genmab, Gracell, Immunitybio, Khondrion, Metacrine, Molecular Templates, Omeros, Pieris, Precision, Steba, Takeda, Tessa, Tracon, Transgene.
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Other news to note for Jan. 19, 2021

Last updated: Jan. 19, 2021
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aavnergene, Advaxis, Aptinyx, Boehringer Ingelheim, Brickbio, Capricor, Cocrystal, Conserv, Cure Genetics, Elsalys, Etana, Everest, Faron, Gritstone, Hanmi, Immunitybio, Innovent, Intravacc, Invixa, Janssen, Lipigon, Merck & Co., Minerva, Miragen, Neucyte, Neurogene, Neurophth, Novadiscovery, Oncosec, Orchard, OS Therapies, Oxford, Propanc, Provention, Royalty, Secarna, Spero, Syntekabio, Tenax, Tennor, Twist, Vigeneron, Viridian.
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In the clinic for Jan. 19, 2021

Last updated: Jan. 19, 2021
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aclaris, Agios, Algernon, Bausch + Lomb, Bioeclipse, Biohaven, Biophytis, Brickell, Caladrius, Debiopharm, Evgen, Genkyotex, Grifols, Incarda, Lixte, Phathom, Sernova, Servier, Sinomab, Sirnaomics, Vallon, Verrica.
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U.S. FDA headquarters

FDA regulatory flexibilities notice raises questions of authorship, consistency

Last updated: Jan. 15, 2021
By Mark McCarty
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The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
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