PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.
The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Eli Lilly, Exact Sciences, Genotests, Insulet, Jenavalve, Photocure, Thermo Fisher Scientific.
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months.
A change of presidential administrations often brings a significant change in regulatory policy, and the Granston memo did just that shortly after the Trump administration took office in 2017. However, the Department of Justice (DoJ) has dismissed fewer whistleblower (qui tam) lawsuits against the private sector recently, a trend that Jonathan Phillips of Gibson Dunn said was evident before the Biden administration took over.
TORONTO – Western New York Imaging Group, a one-hour drive across the U.S.-Canadian border, will soon be the site for a hard launch of Champ, a system developed by Voxneuro Inc. that evaluates suspected cognitive brain disorder or symptoms such as fatigue, memory loss or brain fog. This comes after Voxneuro won FDA registration of the cognitive platform as a class II exempt medical license, followed last month by Health Canada approval of the system for help diagnosing concussion, traumatic brain injury and dementia.
The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity.
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