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Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that its partner Biogen recently received notification from the United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheuma ....
It is the first FDA-approved monoclonal antibody to treat COVID-19, Roche said. WHO says China may be struggling to keep a tally of COVID cases China may be struggling to keep a tally of COVID-19 infections as the country experiences a big spike in cases, a senior World Health Organization official said on Wednesday, amid concerns about a lack of data from the country. ....
SOUTH SAN FRANCISCO (dpa-AFX) - The U.S. Food and Drug Administration has approved Roche's (RHHBY) Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients ....