AB Science granted authorization to initiate confirmatory
PRESS RELEASE AB SCIENCE HAS BEEN AUTHORIZED BY THE SWEDISH MEDICAL PRODUCTS AGENCY TO INITIATE CONFIRMATORY PHASE III TRIAL OF MASITINIB IN PROGRESSIVE...
Source: globenewswire.com
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Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17
Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases The positive opinion is based on Phase I/III study data investigating the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety If approved, CT-P17 would be the first adalimumab biosimilar with high concentration (100mg/mL) and citra...
Source: finanznachrichten.de