The Biden administration sees the $15.6 billion just provided by Congress as inadequate funding for the pandemic, particularly given the administration’s new test-to-treat initiative, and will continue to press Congress for the remaining $6.9 billion requested by the White House, said Tom Inglesby, senior advisor for the White House COVID response team, at the American Clinical Laboratory Association annual meeting. Read More
Brightinsight Inc. and UCB SA struck a deal to jointly develop a digital disease management solution for patients with rare diseases. The companies will start with a mobile app for myasthenia gravis (MG) built on Brightinsight’s platform. UCB joins CSL Behring, Novo Nordisk A/S, Sanofi SA and Roche AG in partnering with Brightinsight on digital disease management. Read More
An analysis of brain scans of participants in the UK Biobank has shown there are significant differences between the condition of the brain before and after mild COVID-19 infection. These included a reduction in overall brain size, reduction in grey matter thickness in the orbitofrontal cortex and hippocampal gyrus, and changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex. Infected participants also showed, on average, a larger cognitive decline than participants who had not contracted COVID-19. Read More
If the U.S. SEC goes forward with amendments it proposed March 9 to enhance and standardize cybersecurity-related disclosures, public biopharma and med-tech companies will have more reporting to do. Read More
Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets. Read More
The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aignostics, Amwell, Aza Technology, Baxter, Cerebriu, Convergent Therapeutics, Digital Diagnostics, Elbit Systems, Element Biosciences, Fabric Genomics, Genomics England, Insitro, Kmc Systems, LG Electronics, Minnetronix Medical, Northstar Medical Radioisotopes, Oculogica, Siemens Healthineers, Ultivue. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BBS-Bioactive Bone Substitutes, Cionic, Medmira. Read More
