Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Basilea, Nodus, Takeda, Tetra, Tikomed, Virogin, Zealand.
Akston Biosciences Corp. emerged from a successful small company that was sold to a pharma major. For Todd Zion, that’s a back-to-basics move that suits him just fine. Zion co-founded Smartcells Inc. in 2003 with technology developed at the Massachusetts Institute of Technology. The company went on to develop the once-daily injectable self-regulating insulin product, Smartinsulin, and sold it to Merck & Co. in what was at the time one of the largest preclinical pharmaceutical acquisitions ever.
Wall Street trimmed shares of Veru Inc. (NASDAQ:VERU) by upwards of 20% in the wake of an editorial published Aug. 23 in The New England Journal of Medicine publication NEJM Evidence. The opinion piece, by two critical-care pulmonologists, added verve to the debate about the efficacy of drugs for people hospitalized with COVID-19.
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.
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