Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Amylyx, Aston, Astrazeneca, Bausch + Lomb, Novaliq, Novavax, Tenaya.
Tetra Bio-Pharma Inc. has signed an agreement with Cellvera Global Holdings LLC for the co-development of ARDS-003 (onternabez) as a combination product with Qifenda (favipiravir) 400 mg, a commercial-stage broad-spectrum antiviral drug.
Biovaxys Technology Corp. has announced that Millipore-Sigma, the contract manufacturer for its preclinical viral vaccine program, has completed the bioproduction and batch release endotoxin screening of BVX-1021, the company's vaccine for SARS-CoV, which is being used in the collaboration with The Ohio State University (OSU) to develop a pan-sarbecovirus vaccine.
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azurity, Bayer, Boehringer, Immuneering, Intellia, Moderna, Novavax, Y-mabs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Aston, Biontech, Genentech, Immusoft, Moderna, Pfizer, Roche, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bridge, Celsion, Ensysce, Helsinn, I-Cordis, Juniper, MC2, Quotient.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Algo, Anaptysbio, Avacta, Axsome, Coya, Pliant, Reveragen, Santhera, Vaxart, Vyluma, Werewolf.
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
RSS
