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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
ARS Pharma
ARS Pharmaceuticals Reports the EC’s Approval of Eurneffy (Adrenaline Nasal Spray) to Treat Type I Allergic Reactions 
Shots:    Following the US FDA approval, the EC has approved Eurneffy (2mg) for type I allergic reactions (anaphylaxis) in adults & children (≥30kg). It will be available in Q4’24 through undisclosed pharmaceutical partner  The approval was supported by the results from a study, involving ~1200 administrations among >700 subjects, along with studies and peer-reviewed literature…
August 26, 2024
Celltrion
Celltrion’s SteQeyma (Biosimilar, Stelara) Receives the EC’s Approval to Treat Various Chronic Inflammatory Diseases 
Shots:  Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications  Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
August 26, 2024
SIFI and Avanzanite Bioscience’s Akantior (Polihexanide) Gains the EC’s Approval to Treat Acanthamoeba Keratitis (AK) 
      Shots:    Following recommendations from the EMA’s CHMP & COMP, the EC has approved Akantior to treat AK among adults & adolescents (≥12yrs.)   Approval was based on the data from P-III (ODAK) study in AK patients (n=135), published in Ophthalmology, demonstrating that the disease cured in 84.8%, full vision restoration was found in 66.7% with…
August 26, 2024
Regeneron
Regeneron’s Ordspono (Odronextamab) Receives the EC’s Approval to Treat R/R Follicular Lymphoma and Diffuse Large B-cell Lymphoma 
     Shots:    The EC has approved Ordspono for treating r/r FL or r/r DLBCL in patients who have progressed after ≥2L of systemic therapy  Approval was supported by Ordspono’s P-I (ELM-1; n=60) trial in patients with CD20+ B-cell malignancies, incl. those who progressed post CAR-T therapy & P-II (ELM-2; n=128) trial for 5 B-cell lymphoma…
August 24, 2024
Moderna’s mRESVIA (mRNA-1345) Vaccine Gains the EC’s Approval to Prevent Lower Respiratory Tract Disease (LTRD) 
Shots:    The EC’s approval of mRESVIA (mRNA-1345) vaccine to prevent LTRD due to RSV infection among adults was supported by P-III (ConquerRSV) trial in adults (n=37,000; ≥60yrs.) & is valid across EU plus as Iceland, Liechtenstein & Norway  Primary analysis (3.7mos. median follow-up) depicted vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis…
August 23, 2024
Johnson& Johnson
Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma 
Shots:    The EC has approved Balversa (oral, QD) monotx. for treatment-experienced adults with inoperable or metastatic urothelial carcinoma (mUC) having susceptible FGFR3 genetic alterations  Approval was supported by results of cohort 1 from the P-III (THOR) trial assessing the safety & effectiveness of Balversa (n=136) vs CT (n=130) to treat mUC with select FGFR alterations…
August 23, 2024
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