Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Burning Rock Biotech, Cyduct Diagnostics, E Ink, Ers Genomics, Flagship Biosciences, Fluorogenics, Fujifilm, Galaxy Medical, Genscript Biotech, Helio Health, Hhc Preferred, Japan Lifeline, Leap Therapeutics, Lucira, New England Biolabs, Novartis, Nuclera Nucleic, Pmb-Alcen, Sagentia Innovation, Sientra, Tilak Healthcare, Wearable Health Solutions.
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Bionostica, Applied DNA Sciences, Biointellisense, Castle Biosciences, Cytosorbents, Doctor On Demand, Grand Rounds Health, Ott Scientific, Protech Home Medical, Quipt Home Medical, Speedx, Veemed.
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Conformis, Edge Surgical, Inova Diagnostics, Ortho Development, Orthofix, Think Surgical.
The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amt, My01, Renovacare, Viome.