With the first global approval by Health Canada in hand, Medicago Inc. aims to provide 20 million doses this year of Covifenz – which itself represents another first, as a plant-originated, virus-like particle, recombinant, adjuvanted COVID-19 vaccine. “Hopefully, if all goes well, we’ll be able to do it faster than the last day of the last month” of the year, said Brian Ward, medical officer of Quebec City-based Medicago, a unit of Mitsubishi Tanabe Pharma Corp., which partnered on Covifenz with Glaxosmithkline plc (GSK).
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware.
The FDA has approved Medtronic plc’s next-generation sacral neuromodulation (SNM) system, Interstim X, giving patients a recharge-free option with a 10-year+ lifespan. This newest member of the Interstim portfolio joins the rechargeable Interstim Micro as a treatment for overactive bladder (OAB), chronic fecal incontinence (FI) and nonobstructive urinary retention.
A neurostimulation device developed to treat focal epilepsy has received breakthrough device designation from the FDA. Precisis AG’s Easee [Epicranial Application of Stimulation Electrodes] minimally invasive system is designed to deliver individualized brain stimulation without neurosurgery. The electrode is placed subcutaneously on the cranium and a current is applied to the affected brain area to prevent or mitigate seizures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic.
A sense of normalcy is returning to the U.K., at least from a regulatory perspective. The U.K.’s Medicines and Healthcare Products Regulatory Agency will continue to support COVID-19 clinical trials with ongoing regulatory and scientific input, but all further applications and meeting requests for COVID-19 products will be considered according to usual timelines rather than on an emergency basis, the agency said Feb. 23.
On the success of last year’s establishment of a global mRNA vaccine technology transfer hub in South Africa, the World Health Organization (WHO) announced its next step Feb. 23: the creation of a global biomanufacturing training hub in South Korea that will serve low- and middle-income countries wanting to produce biologics, such as vaccines, insulin, monoclonal antibodies and cancer treatments.
The U.S. SEC reported a settlement Feb. 23 with Baxter International Inc. and its former treasurer, Scott Bohaboy, and former assistant treasurer, Jeffrey Schaible, resolving charges involving years of improper intra-company foreign exchange transactions that resulted in the misstatement of Baxter’s net income.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Pharma, AB Science, Abbvie, Armata, Bharat Biotech, Beigene, Cansino, Homology, Ocugen, Provention, RDIF.
Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access.
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