Laboratorios Farmacéuticos Rovi, S.A.
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Latest From Laboratorios Farmacéuticos Rovi, S.A.
Novel Sickle Cell Treatment Among 13 New Drugs On Track For EU Approval
A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.
Speculation Over Moderna Vaccine Deal With Tata, Wockhardt
Moderna is speculated to be in talks with Indian firms, including Wockhardt and a Tata group company, for manufacturing and/or marketing its COVID-19 vaccine. A deal in India could help the company meet its obligation to supply COVAX but Moderna is likely to choose its partner carefully.
Rovi Is Weeks From Long-Acting Risperidone Filing
Rovi hopes by the end of this year to file a hybrid marketing authorization application in Europe for a once-a-month sustained-release injectable formulation of risperidone. A US filing is scheduled for the first half of next year.
Rovi Prioritizes Risperidone Filing In Europe Over US
Spain’s Rovi is prioritizing European filing and filling preparations for its long-acting risperidone injectable, pushing back a prospective US regulatory submission until next year.
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