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BioWorld - Monday, July 6, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Aug. 14, 2020

Aug. 17, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Kempharm, Mesoblast, TLC, Verona.
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European Commission’s first COVID-19 deal goes to Astrazeneca while Novavax signs U.K agreement

Aug. 14, 2020
By Lee Landenberger
Astrazeneca plc is the first company to sign an agreement with the European Commission to supply a COVID-19 vaccine.
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IPO line graph

Curevac IPO, bolstered by COVID-19 vaccine, debuts to surging demand

Aug. 14, 2020
By Michael Fitzhugh
Fresh off raising $640 million in private financing earlier this summer, Germany's Curevac BV burst onto the public market Friday with a $213.3 million Nasdaq IPO. Priced at a top-of-range $16 per share (NADAQ:CVAC), the company's stock rose more than 249% to close at $55.90 Aug. 14, buoyed by enthusiasm for its mRNA vaccine program against SARS-CoV-2. Majority shareholder and longtime Curevac backer Dievini Hopp Biotech Holding GmbH & Co. KG invested €100 million (US$118.3 million) in the company through a concurrent private placement.
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TSX gives thumbs up on documentation supporting agreement on rapid saliva, COVID-19 test

Aug. 14, 2020
By David Godkin
TORONTO – The Toronto Stock Exchange (TSX) has accepted documentation supporting a binding letter of intent between Toronto-based Therma Bright Inc. and arm's-length vendor Orpheus Medica Inc. for development of a rapid saliva, COVID-19 test.
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Sampinute system and Diatrust packaging

Testing, testing as Celltrion aims to launch two COVID-19 kits in the U.S.

Aug. 14, 2020
By Gina Lee
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.
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Other news to note for Aug. 14, 2020

Aug. 14, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biolog, Biospyder, Capsa Healthcare, Connecticut Biotech, Formsense, Htg Molecular Diagnostics, Newrobo, Newsight Imaging, Protokinetix, Sheba Medical Center, Todos Medical, Virusight Diagnostics, Virushield, Xphyto Therapeutics.
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Other news to note for Aug. 14, 2020

Aug. 14, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dr. Falk, JN Nova, Lumos, Merck, Prometheus, Revive.
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Globe showing Asia-Pacific region

‘Made-in’ policies for medical devices spreading across Asia-Pacific region

Aug. 13, 2020
By Mark McCarty
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
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Immunoscape to scale up immune profiling technology with $11M in new global funding

Aug. 13, 2020
By Annette Boyle
Immunoscape Ltd. closed an $11 million global equity financing round led by U.S.-based venture firm Anzu Partners along with University of Tokyo Edge Capital in Japan, and Indonesia's NPR Holdings. The company plans to use the funds to ramp up its immune profiling technology platform, which performs deep T-cell analysis, and expand partnerships to develop vaccines for COVID-19 and other viruses as well as targeted oncology therapies.
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 13, 2020
By Mari Serebrov
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
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