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BioWorld - Monday, May 11, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for April 28, 2022

April 28, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Allogene, Alterity, Antengene, Astrazeneca, Aviadobio, Bayer, Biocryst, Biohaven, Direct, Fennec, Maia, Molecular Partners, Novartis, Orexo, Pfizer, Prothena, Renovion, Treadwell.
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Shionogi releases positive results, back on track for COVID-19 treatment

April 27, 2022
By Gina Lee
New trial results presented by Shionogi & Co. Ltd. at the 32nd European Congress of Clinical Microbiology and Infectious Diseases showed the company’s 3CL protease inhibitor, S-217622, was well-tolerated, with the potential to rapidly clear SARS-CoV-2, Simon Portsmouth, executive medical director at Shionogi, told BioWorld.
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Becerra on the hot seat in US House budget hearing

April 27, 2022
By Mari Serebrov
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
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Ashvattha lands $69M series B, Huadong licensing deal

April 27, 2022
By David Ho
Ashvattha Therapeutics Inc. secured $69 million in a series B financing that it said will strengthen its ability to develop hydroxyl dendrimer-based medicines and accelerate efforts to advance its candidates to the clinic.
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Stock prices with loss/gain arrows

Possible EUA hitch and Amgen give-back dent Molecular Partners

April 27, 2022
By Jennifer Boggs
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
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Regulatory actions for April 27, 2022

April 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Editas, Evoke, Gamdia, Gilead, Lemonex, OncoC4, Pharming, VBL.
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In the clinic for April 27, 2022

April 27, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABVC, Arrowhead, Bergenbio, Citius, Galecto, Jubliant, Novaliq, Point, Protagonist, Sotio, Starton, Valneva.
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US booster study next after Arcturus’ self-amplifying mRNA COVID-19 vaccine hits endpoints

April 26, 2022
By Jennifer Boggs
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines.
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Regulatory actions for April 26, 2022

April 26, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Astrazeneca, Autolus, Langsheng, Merck & Co., Obseva, Priothera, Quoin, Roche, Sol-Gel, Sorrento, Valneva.
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In the clinic for April 26, 2022

April 26, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Applied Molecular, Athenex, Eiger, Eliem, Gossamer, Immunitybio, Kiora, Lyra, Mundipharma, Mustang, Nkarta, Ocugen, Orasis, Orca, Pfizer, Rockwell, Veru.
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