PERTH, Australia – Biopharma stakeholders are furious about the consultation process the Australian government has pursued with its review of the country’s National Medicines Policy, and they are asking the government to hold off on making any changes until after the federal election that is scheduled for May.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Glaxosmithkline, Hightide, Sanofi.
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.
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