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Zevra Therapeutics
Zevra Therapeutics Receives the US FDA’s Approval of Miplyffa (Arimoclomol Citrate) for Treating Niemann-Pick Disease Type C (NPC) 
Shots:     The US FDA has awarded priority review voucher & approved Miplyffa (47mg to 124mg, oral, TID) + miglustat to treat neurological manifestations in adults & pediatrics (≥2yrs.) with NPC, with its launch planned within 8-12wks.    Approval was based on trial of Miplyffa + miglustat vs PBO in NPC patients (2-19yrs.), showing halted disease progression…
September 20, 2024
Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 
  Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
September 18, 2024
Accord Healthcare
Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 
Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 2024
Roche
Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis 
Shots:     The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)  The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…
September 13, 2024
The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors
Shots:  The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer   HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…
September 2, 2024
Roche
Roche’s PiaSky Receives the EC’s Approval to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH) 
Shots:    The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve  Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients…
August 27, 2024
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