The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment […]Read More
Shots: CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019 The CHMP’s opinion is based on data evaluating the PK, efficacy and safety between CT-P13 SC to CT-P13 IV […]Read More
Shots: The US FDA has approved Keytruda’s additional recommended dosage of 400 mg (q6w) across all adult indications, including monothx. and combination therapy. The new dosage option will be available in addition to the current dose of Keytruda (200 mg, q3w) The indication is approved under accelerated approval based on PK data, the relationship of […]Read More
Copyright ©2020 PharmaShots | Powered by Octavus Consulting
