Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Direct Biologics, Lexicon, Netris, Redhill.
While several companies are looking to help recurrent glioblastoma patients, Carthera SAS has taken a step forward by bringing its Sonocloud-9 device into a phase I/II clinical trial. Northwestern University in Chicago will collaborate with the company in the trial, which is expected to enroll up to 39 patients. The first patient already has been treated.
Results of a futility analysis prompted Regeneron Pharmaceuticals Inc. to continue the phase III study of its virus-neutralizing monoclonal antibodies, a REGN-10933 and REGN-10987 cocktail for treating hospitalized COVID-19 patients who are seronegative and need low-flow oxygen.
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Volunteers who received the vaccine in the phase III experiment produced high-tier antibodies, with a neutralizing antibody positive conversion rate of 99.52% after two doses, the company said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Chiesi, Codiak, Emergent, Hepion, Lipocine, Neurorx, Nicox, Protalix, Regeneron, Sinopharm.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Arcturus, Intra-Cellular, Nanology, VBL.
Shares of Aprea Therapeutics Inc. (NASDAQ:APRE), a company focused on developing therapies that reactivate the mutant tumor suppressor protein p53, fell 78.1% to $5.50 on Dec. 28, just north of its cash balance, after a pivotal trial of its lead candidate missed its endpoint, leaving the asset's future hazy and likely scuttling plans the company had for a first quarter 2021 NDA filing.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Algernon, Aprea, Gannex, Inovio, Lysogene, Novavax, Taiwan Liposome.
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