In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Pharma, AB Science, Abbvie, Armata, Bharat Biotech, Beigene, Cansino, Homology, Ocugen, Provention, RDIF.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ariana, Atma Journey, Aulos, Cyclerion, Filament, Foresee, Jnana, Synaptogenix, Trpharm and Vicore.
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Foundation Medicine, Gramercy Extremity Orthopedics, Lumiradx, Olympus, Precisis.
Shares in Synairgen plc have cratered after a phase III trial of its inhaled COVID-19 therapy SNG-001 failed to produce conclusive results, with the company blaming improvements in standard care for the disappointing findings in patients hospitalized with the disease. The Southampton, U.K.-based biotech’s shares (LSE:SNG) touched lows of 10 pence, down 94%, and stabilized around 85% below their previous closing price of £25.36 after the announcement on Monday.
China is the latest country mixing things up when it comes to COVID-19 boosters. Since boosters were implemented in China in October, adults have been given a third dose of their primary vaccine regimen, which has consisted of one of three inactivated vaccines produced by Sinopharm Group Co. Ltd. and Sinovac Biotech Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Biomarin, Dizal, Novavax, Ose, Transthera, UCB, Veloxis.
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
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