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TORONTO – A portable DNA-based test kit developed by Ottawa-based Spartan Bioscience Inc. has received Health Canada approval for COVID-19 testing – this at a time when hospitals are under enormous pressure to meet increased testing demand.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Baxter, Biocomposites, Cagent Vascular, Mevion.
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19.
LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Aivita, Amryt, Astrazeneca, Baudax, Cel-Sci, Incyte, Leap, Obseva, Sanofi, Surface, Theravance, United Therapeutics, Windmil.
The Main Street Lending Program (MSLP) was designed to ensure that small businesses are able to stay in business during the economic damage incurred by the COVID-19 pandemic, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA) says the program’s provisions are leaving some small device makers out in the cold, a predicament MDMA is working to resolve.
While many companies are looking to help monitor patients at home during the COVID-19 pandemic, 11 Health and Technologies Inc., of Irvine, Calif., is focused on those with chronic digestive diseases. The company recently said it was offering 12 weeks of free service using the Alfred Smartcare Platform to provide support for people with conditions such as inflammatory bowel disease, colorectal cancer and ostomies.
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