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Greenlight Biosciences Holdings PBC has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a first-in-human phase I/II trial of its mRNA vaccine candidate against COVID-19, GLB-COV2-043, as a booster for previously vaccinated individuals.
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Argenx, Astrazeneca, Bioaegis, Bloomsbury, Bristol Myers Squibb, Eisai, Eli Lilly, Exegi, Ipsen, Merck, Orion, Regeneron, Sana, Sanofi, Viatris.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Centessa, Daewoong, Daiichi, Discgenics, Lapix, Syros, Valeo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acerus, Altamira, Celularity, F-star Immusoft, Inbox, Lighthouse Pharma, Liminal, Novavax, Quince, Senti, Sino, Siva, Sona.
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Axcella, Biontech, Carina, Cullinan, Decibel, Diamond, Immpact, Kura, Oxular, Pfizer, Polypid, Verrica.
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