Active Biotech AB: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
Provider: MarketLine (a Datamonitor Company)
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European Medicines Agency Completes Validation Process for Marketing Authorization Application of Active Biotech AB and Teva Pharmaceutical Industries Ltd's Laquinimod
Active Biotech AB announced that the European Medicines Agency (EMA) has completed the validation process for the marketing authorization application (MAA) of the medicinal product laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS), developed in cooperation with Teva Pharmaceutical Industries Ltd. The completion of the MAA validation process and acceptance for review leads to the formal scientific review process by EMA's Committee for Medicinal Products for Human Use. This acceptance of the EMA filing for review triggers a payment of USD 5 million to Active Biotech from Teva. The MAA submission is supported by a pooled analysis of data from the two global Phase III clinical trials in RRMS involving more than 2,400 patients treated for two years, the ALLEGRO and BRAVO trials. This analysis further strengthens the positive results achieved in the studies. Additionally, Active Biotech and Teva continue to work with the Food and Drug Administration to determine the regulatory path forward for laquinimod in the United States.
Latest Developments for Active Biotech AB
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Post-Hoc Analyses of Phase III ALLEGRO and BRAVO Studies
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Publish Pre-Planned Analysis of Phase III ALLEGRO Study
- Active Biotech AB to Present Further Analysis Supporting Effect of ANYARA in Biomarker Defined Subgroup
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis
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