The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
An interdisciplinary research team from the Hong Kong Polytechnic University has developed a portable testing device that can detect the COVID-19 virus within 40 minutes.
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
Shionogi & Co. Ltd.’s plan to make ensitrelvir, an oral antiviral for COVID-19, the first domestically approved COVID-19 treatment has hit a snag. Animal studies showed the drug, also known as S-217622, disturbed fetal development, according to media reports.
Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines.
