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BioWorld - Tuesday, December 30, 2025
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 3, 2021

May 3, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna.
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Other news to note for May 3, 2021

May 3, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actuate, Biovaxys, Cocrystal, Enteris, Esteve, Gain, Gemini, Gensight, Hoth, Immunicum, J&J, Kowa, Lantern, Moderna, Moonlake, Merck KGaA, New Life, Ocugen, Revive, Samsung Bioepis, Sonnet, Tryp, Xoma.
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In the clinic for May 3, 2021

May 3, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Aeglea, AGTC, Alnylam, Biogen, BMS, Eiger, Cabaletta, Denali, Jcyte, Lilly, Lineage, Mallinckrodt, Novan, Novartis, Novavax, Regulus, Repare, Sandoz, Sarepta, Seqirus, Sunovion, Xenothera, Zealand.
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Other news to note for April 30, 2021

April 30, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arup Laboratories, Conventus-Flower, Cynosure, Evon Medics, Genome Medical, Midiagnostics, Myellevate, Patientsafe Solutions, Red One Medical, Specific Diagnostics, Techcyte, Vocera.
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IPO puzzle pieces

Vaccitech, Werewolf IPOs launch to divergent receptions

April 30, 2021
By Michael Fitzhugh
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10.
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Drug vials

Fixes to Bayview plant Emergent soon? FY21 guidance clipped

April 30, 2021
By Randy Osborne
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
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Patient in hospital bed

Real-world U.K. data show small number of COVID-19 vaccine failures

April 30, 2021
By Nuala Moran
LONDON – The latest tranche of data from an array of large-scale COVID-19 studies running in the U.K. provides real-world evidence that vaccines have a dramatic effect in preventing hospitalization and death, but that there are a very small number of vaccine failures. The data cover 3,842 people who received a vaccine and subsequently were admitted to the hospital between Dec. 8, 2020, when the national vaccination rollout began, and the data cutoff of April 10, 2021.
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Regulatory actions for April 30, 2021

April 30, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Biocryst, Biomarin, Biontech, BMS, Eagle, Hikma, Janssen, Legend, Leo, Pfizer, Praxis Precision Medicines, Therapeutic Solutions International, Xeris.
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Other news to note for April 30, 2021

April 30, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AKL, Alkermes, Centivax, Fera, Ibsa, Mereo, Nicox, Novavax, Scipher, Sola.
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In the clinic for April 30, 2021

April 30, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB, Eloxx, Mesoblast, Phathom, Scynexis, Synairgen, Tessa, Treadwell, Vifor.
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