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BioWorld - Thursday, June 1, 2023
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 1, 2023

May 1, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, H. Lundbeck, Moderna, Otsuka, Pfizer, Rnaimmune, Senhwa.
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Coronavirus vaccine illustration
Immune

Rnaimmune’s SARS-CoV-2 vaccine booster candidate RV-1730 cleared to enter clinic in US

April 28, 2023
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Rnaimmune Inc., a nonwholly owned subsidiary of Sirnaomics Ltd., has received clearance from the FDA for its IND application to conduct a phase I trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
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In the clinic for April 27, 2023

April 27, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Allovir, Avenge, Belite, Biomind, Bloom, Calico, Contrafect, Evelo, Impel, Inhibikase, Inhibrx, Kancera, Kiora, Lianbio, Lineage, Novartis, Otsuka, Prilenia, Roche, SAB, Sunovion.
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Regulatory actions for April 26, 2023

April 26, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Atea, GSK, Hipra, In8bio, Invivyd, Myrtelle, Santhera, Stoke, Tarsier, Virios.
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Woman holding head, low battery symbol

US FDA turns to patients to deepen understanding of long COVID

April 25, 2023
By Mari Serebrov
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As it requested, the U.S. FDA got an earful April 25 as people with long COVID and their caregivers shared their experiences with the condition that has no approved, or even authorized, treatment and is not that well understood, given its range of symptoms that vary from person to person.
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In the clinic for April 21, 2023

April 21, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Beigene, Bioinvent, Cantex, Dare, Maia, Promore, Sellas, Visus.
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China: Vaccine platforms, research needed as pandemic wanes

April 20, 2023
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While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. To date, China has 17 COVID-19 vaccine products that have completed or are in phase III trials, according to the NMPA.
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Other news to note for April 19, 2023

April 19, 2023
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Direct, Everest, Finch, Keyuan Xinhua, Maxion, Nona, Shanghai, Sinopia.
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In the clinic for April 19, 2023

April 19, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Alzamend, Alzheon, Anixa, Arch, Autobahn, Biolinerx, Clearside, FSD, Lisata, Madrigal, Merus, Nova Mentis, Plus, Renovion, Sellas, Technoderma.
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US FDA bids adieu to monovalent COVID-19 vaccine

April 18, 2023
By Mari Serebrov
No Comments
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
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