The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Biontech, Catalyst, Elusys, Kempharm, LG Chem, Mesoblast, Oyster Point, Pfizer, Protagonist, Regent, Telix, Vanda, Wanbang.
Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adapthealth, Aerocare Holdings, Ams, Bayer, Biotricity, Biovo Technologies, Blackford Analysis, Boston Scientific, Change Healthcare, Decision Diagnostics, Eir Healthcare, Electrocore, Ers Genomics, GE Healthcare, Health Decisions, Healthstream, Illumina, Irhythm Technologies, .lumen, Meso Scale Diagnostics, Nanostring, New England Home Medical Equipment, Nuance, Nvidia, Oncobay Clinical, Pieriandx, Premier Medical Laboratory Services, Serb, Stark International Lux, TCA/Genetworx Labs, The iQ Group Global, Vesper Medical, Vivlion.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baylis Medical, Biocardia, Biodesix, Bioskryb, Caredx, Hancock Jaffe Laboratories, Ihealthscreen, Multi Radiance Medical, Quotient, Sensus Healthcare.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
Despite concerns to the contrary, none of the mutations currently documented in the SARS-CoV-2 virus appear to increase its transmissibility in humans, according to a new analysis of viral genomes from 46,723 people in 99 countries who contracted COVID-19.
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