Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai.
BEIJING – During the market downturn caused by COVID-19 disruptions, biotech and med-tech companies continue to attract investors at a time when medical solutions are needed more than ever. Qiming Venture Partners said that it has established a new $1.1 billion fund to target early stage health care and technology investments, the latest good news sector for biopharma and med-tech startups.
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
As state and federal authorities deliberate over how to safely reopen U.S. society during the ongoing COVID-19 pandemic, tools that effectively monitor body temperature at a population level could help to get the ball rolling. To that end, software development firm Altoros Inc., of Sunnyvale, Calif., has released the Fever Screener, a fully automated, enterprise-grade system for setting up temperature scanning checkpoints. Fever Screener can scan up to 30 people simultaneously at a distance of 3 meters, or nearly 10 feet, with a temperature accuracy of roughly 0.6 degrees Fahrenheit. Installed in entryways, checkpoints or other crowded venues, it can provide mass screenings, as well as recurrent temperature monitoring for potentially infected individuals.
Johnson & Johnson (J&J) managed to beat analyst earnings estimates due to unexpectedly strong first-quarter results in its consumer health and pharmaceutical businesses. But while those saw revenues climb in the double digits, its medical devices business declined by almost 5% due to deferred procedures. Wall Street rewarded the New Brunswick, N.J.-based company by driving its shares (NYSE:JNJ) up more than 5%. That’s even though the company also lowered its 2020 guidance.
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
Within two weeks of a public challenge to design user-friendly, easily built ventilators, Montreal-based CAE Inc., formerly Canadian Aviation Electronics, began gearing up to distribute 10,000 units of its newly created ventilator over the next three months.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Chembio, Nova Biomedical, Ortho.