OR WAIT null SECS
November 12, 2021
The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.
The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.
Fujifilm is expanding its R&D footprint at its California facility.
Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.
Sotera’s acquisition of Regulatory Compliance Associates (RCA) will expand its technical consulting services.
AbbVie will pay REGENXBIO up to $1.75 billion for the rights to develop and commercialize its treatment of various eye conditions.
European Medicines Agency (EMA) granted Rafael’s CPI-613 (devismat) an orphan drug designation for the treatment of refractory or relapsed Burkin’s lymphoma.
November 11, 2021
The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.
Hovione will invest $170 million in new capacity and capabilities in Portugal, Ireland, and New Jersey
November 10, 2021
The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.
