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xbrane
Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate 
Shots:  Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024  The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…
December 31, 2024
Johnson& Johnson
Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC 
Shots:      The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month)  Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…
December 30, 2024
BMS
BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications 
Shots:    The US FDA has approved Opdivo Qvantig (nivolumab & hyaluronidase-nvhy) SC injection for previously approved solid tumor Opdivo indications, incl. as monotx., maintenance therapy after Opdivo-Yervoy combination & with CT or cabozantinib  Approval was based on P-III (CheckMate-67T) study assessing Opdivo Qvantig (nivolumab: 1,200mg & hyaluronidase: 20,000 units, SC, Q4W; n=248) vs Opdivo (3mg/kg,…
December 27, 2024
Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia 
Shots:  Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia  The alliance will utilize Tabuk's local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities  BAT2206, a proposed biosimilar to…
December 24, 2024
Novo-Nordisk
Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors 
Shots:    The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors  Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…
December 20, 2024
Ionis
Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS) 
Shots:    The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned   The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…
December 19, 2024
Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara) 
Shots:  Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Janssen's Stelara (Ustekinumab), following CHMP’s positive opinion & FDA's approval  Imuldosa, initially developed by Dong-A Socio Holdings & Meiji Seika Pharma, & was transferred to Dong-A ST in 2020 for global development and commercialization. In 2021, it was out-licensed to Intas Pharmaceuticals for…
December 19, 2024
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