Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelmed, Aidoc, Avita Medical, Bellerophon Therapeutics, Datametrex AI, Fresenius Medical Care North America's Renal Therapies Group, Gaia, Inspire Medical Systems, Kc Wearable, Mevion Medical Systems, Orexo, Perkinelmer, Quest, Rochal Industries, Sanara Medtech, Seevix, Tearlab, Technopath, Telemedicine Clinic, Tissue Regenix, Unilabs, Zoll.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aspenstate, Elemaster, Myriad, Visioncare.
After being hit with the major financial market meltdown when the COVID-19 outbreak decimated U.S. capital markets during March that saw the valuations of public biopharmaceutical companies developing new medicines plummet, it appears that they have put that reversal behind them with a dramatic price surge in April.
Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
HONG KONG – The Japanese government is tightening its grip on its listed companies, including those working on promising COVID-19 treatments. On May 8, the Japanese Ministry of Finance released a list of 518 companies that would be subject to stricter restrictions on receiving foreign investments.
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.
