The controversial approval of Biogen Inc.’s Aduhelm (aducanumab) in June sharply increased the interest in developing a quick, painless method of diagnosing Alzheimer’s disease (AD). Now, more than half a dozen blood-based diagnostic assays are in development and one is commercially available, albeit without FDA clearance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine, Thermo Fisher.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augmedix, Aspen Laser, Cardiovalve, Denovo, Dotz, Exergen Inspira, Innovimed, Leap Pal Parts and Consumables, M2gen, Microsoft, Proximie, Qiagen, Seegene, Sidem, Trajan, Venus Medtech, Vivos Therapeutics.
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition. The technology delivers up to six times more medication to the lungs compared to jet nebulizers. It also enables consistency and drug denaturing to improve efficacy. Cansino and Aerogen did not disclose the deal’s commercial terms.
The Russian Federation is making progress in building its drug supply system and increasing access to medicines and medical devices. In a Dec. 7 update on the progress being made, Minister of Health Mikhail Murashko highlighted the work of the Circle of Kindness fund, efforts to ensure the availability of vaccines and other drugs throughout the federation, and the launch of a labeling system to promote the timely identification of uncertified and counterfeit drugs.
U.S. President Joe Biden has yet to nominate a new director to helm the National Institutes of Health (NIH) when Francis Collins steps down next week, but in the interim, Lawrence Tabak, the principal deputy director at the agency, will serve as the acting director beginning Dec. 20.
Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.
Sonic Incytes Medical Corp. collected $7.3 million in a series A fundraising round to bring its liver-focused point-of-care ultrasound solution to commercialization. Nimbus Synergies led the round with participation from Nicola Wealth, Mint Venture Partners, Consortium Medteq, Wavemaker Three-Sixty Health, Gaingels, INP Capital and several angel investors. The round was oversubscribed by 150%. The hand-held Velacur system noninvasively quantifies liver volume, stiffness and attenuation, critical factors in diagnosing and monitoring liver disease in a process that takes about five minutes and can be performed in a physician’s office. The system received FDA clearance late last year.
RSS
