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Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…

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Bio-Thera and Jamjoom Pharmaceuticals

Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)

Shots: Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA) As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…

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Novartis

Novartis Reports Topline P-III (GCAptAIN) Trial Findings of Cosentyx (Secukinumab) for Giant Cell Arteritis

Shots: Novartis has reported topline P-III (GCAptAIN) trial results on Cosentyx to treat adults with newly diagnosed or relapsing giant cell arteritis (GCA) The P-III (GCAptAIN) trial assessed efficacy & safety of Cosentyx (300 or 150mg) vs PBO, both in combination with a glucocorticoid taper regimen, in GCA pts across 27 countries In the trial,…

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