OSE Immunotherapeutics, a clinical stage biotechnology company, announced today (2/17) that it was granted a patent by the European Patent Office (EPO) for its anti-interleukin-7 receptor (IL-7R) antagonist OSE-127/S95011. The patent, set to last until 2037, covers...
The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations...
The U.S. Food and Drug Administration (FDA) granted BD Emergency Use Authorization (EUA) for a new molecular diagnostic test for COVID-19 and the Influenza A+B virus that provides results within 2-3 hours. The test has already been CE marked for the IVD Directive....
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) the Eli Lilly’s etesevimab in combination with another AbCellera and Eli Lilly’s monoclonal antibody bamlanivimab for treating mild to moderate COVID-19 in patients 12 years or...
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Amarin Corporation PLC announced today (2/9) that its corporate partner, Edding, has progressed VASCEPA® (icosapent ethyl) for Hong Kong and Mainland China’s regulatory review processes. Based on the clinical data for VASCEPA®, including Phase III studies...
The U.S. Food and Drug Administration (FDA) has granted Puzzle Medical Devices Inc. a Breakthrough Device Designation for its minimally invasive transcatheter heart pump. The revolutionary device is meant for patients with minimal trauma for blood components to...
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have...
Singapore has become the first Asian country that has approved the Moderna COVID-19 vaccine as it begins its efforts in implementing its immunization program. The first shipment of Moderna’s vaccine is expected sometime around March. Currently, 175,000 of Singapore’s...
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