Discover
Tremfya (guselkumab) / J&JHealth Canada Approves TREMFYA (guselkumab injection), a First-In-Class Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis (Canada Newswire) - Sep 10, 2020 - "Janssen Pharmaceutical...today announced that Health Canada has approved TREMFYA® (guselkumab injection) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation...This approval for TREMFYA® is based on results from two pivotal Phase 3 clinical trials; DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA..."Zejula (niraparib) / GSK, ZAI Lab, J&J, TakedaZai Lab Announces NMPA Approval of ZEJULA (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China (GlobeNewswire) - Sep 10, 2020 - "Zai Lab Limited...announced that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy."Trikafta (elexacaftor/tezacaftor/ivacaftor) / VertexVertex Announces Positive Phase 3 Study for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children Ages 6-11 Years With Cystic Fibrosis to Support Submissions for Global Regulatory Approvals (Businesswire) - Sep 10, 2020 - P3, N=66; NCT03691779; Sponsor: Vertex Pharmaceuticals Incorporated; "Vertex... today announced the company has completed a global Phase 3 study of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children ages 6 through 11 years old with cystic fibrosis (CF)...based on the results will submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020, with additional global regulatory submissions to follow....The primary endpoint of the study was safety and tolerability, and the results showed that TRIKAFTA was generally well tolerated and the safety data were consistent..."Medexus Reports Health Canada Approval of Gleolan (5-ALA) for Use in Guided Surgical Resection of High-Grade Gliomas (GlobeNewswire) - Sep 10, 2020 - "Medexus Pharmaceuticals Inc...announces that on September 9, 2020, it received a Notice of Compliance from Health Canada granting approval for the marketing of Gleolan® in Canada. Gleolan® is a 5-aminolevulinic acid hydrochloride (5-ALA) powder for oral solution, and is indicated as an adjunct for the visualization of malignant tissue during surgery in patients with Grades III or IV gliomas (suspected on preoperative imaging) as classified by the World Health Organization (WHO)."Keytruda (pembrolizumab) / Merck (MSD); ICT01 / ImCheck TherapImCheck Achieves Initial Positive Independent Safety Review and Initiates Next Stage of Phase I/IIa EVICTION Trial for ICT01 (GlobeNewswire) - Sep 10, 2020 - "ImCheck Therapeutics announced....that the independent Safety Review Committee for the EVICTION Phase I/II clinical trial for its lead antibody ICT01 (NCT04243499) unanimously approved dose escalation in the solid tumor indications and the start of enrollment in the two other arms of the study: treatment with ICT01 in patients with hematologic malignancies as monotherapy and in solid tumor patients in combination with pembrolizumab. The first patients in the second cohort have now been treated...ImCheck’s Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) cleared in August of this year..."
