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.
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26
meeting of the Vaccine and Related Biological Products Advisory Committee.
Axcella Therapeutics Inc. is working on its comeback to make something else go away. Just before Christmas, Axcella said it was repositioning itself to focus on long COVID-19 and was just granted regulatory guidance on a primary endpoint and study design from the U.K.’s MHRA to conduct a single registration trial of AXA-1125 for those with long COVID fatigue. Axcella will be meeting with the MHRA in the near term to discuss getting an innovative licensing and access pathway application, which is designed to accelerate the approval process. Axcella also has just submitted its IND to the U.S. FDA for a global phase IIb/III study for treating long COVID.
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