In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Dcao Solutions, Gentex, Icecure Medical, Masimo, Premier, Retispec, Senseonics Holdings, Spineology, Terumo, Vaxxas, Xenocor.
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) climbed 19.4% to $4.86 Oct. 5 after the company said updated data from an ongoing phase I study of CPI-006 as an immunotherapy for COVID-19 continued to support its development in that area.
According to BioWorld, almost $85 billion was raised by public and private biopharma companies globally in the second and third quarters alone, bringing the dollars generated to date to more than $100 billion – a total that smashes the existing record of about $69 billion that was raised in 2015.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study showing the antiviral is not effective in this context, published in The Lancet on Oct. 5.
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.