OSE Immunotherapeutics Strengthens IPR for Anti-interleukin-7 Receptor (IL-7R) Antagonist OSE-127/S95011
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...
AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO
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...
FDA Grants EUA for New Molecular COVID-19 Diagnostic Test
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....
FDA Issues EUA for Eli Lilly’s Antibody Combination for Mild to Moderate COVID-19
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 Withdraws Application for EUA of COVID-19 Vaccine in India
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 Announces Update on Mainland China and Hong Kong Regulatory Review Processes for VASCEPA® (icosapent ethyl)
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...
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