It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aarvik, Almac Discovery, Antisense, Avenge, Emerald, Emtora, Innoviva, La Jolla, Larkspur, Lytic Solutions, Moderna, Nighthawk, Nrx, Panther, Relief, Skye, Vaderis, Verve and Zyversa.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astellas, Aum, Biocryst, Curis, Genfleet, Junshi, Novavax, Oncopeptides, Otsuka.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Cybin, Enlivex, GSK, Novavax, Omeros, Organon, Otsuka, Redhill, Samsumg, SK.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Proteome, Atomwise, Bristol Myers Squibb,Codagenix, Defence, Endo, Ibio, Innocan, Sanofi, Scilex, Turning Point.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Antengene, Aptinyx, Gannex, Greenwich, Mersana, Newamsterdam, Palatin, Pfizer, Pneumagen, Revive, Unity, Ventyx.
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