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Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots: Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…
October 11, 2024

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Samsung Bioepis
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Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

 Shots:   The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab) Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …
July 22, 2024

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Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

Shots: Björn Mellgård Vice President and Global Program Lead, TTP Program, Takeda, shares insights from the P-III data of TAK-755 for the treatment of cTTP  Björn eloquently shares the highlights of the study design for TAK-755, safety and efficacy outcomes, and goes on to share an update from the P-IIIb continuation trial evaluating TAK-755  With…
October 19, 2023

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Tahi Ahmadi and Asud Khaliq Share their Views on EPKINLY (epcoritamab) U.S. FDA Approval in DLBCL

Shots:Tahi and Asud initiated the conversation with an overview of EPKINLYTM (epcoritamab) and its approval by the U.S. FDA to treat R/R DLBCLThey then spoke about the study design and results from the EPCORE NHL-1 P-I/II trial that served as the basis for the U.S. FDA approval of EPKINLY.EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie. Both companies are evaluating…
August 2, 2023

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Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

Shots:Olivier highlighted the P-II/III data based on which Regeneron’s BLA for Pozelimab was accepted by the US FDA under priority review to treat adults and children with CHAPLE diseaseCHAPLE disease is driven by an overactivation of the complement system due to CD55 deficiency. Pozelimab blocks the activity of complement factor C5 and prevents…
July 17, 2023

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Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on BLA Acceptance for BIIB800

Shots:Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritisHe briefed about the study design and results from the P-III trial which supported the BLA filingThis interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…
July 10, 2023

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Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots:Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanomaShe also spoke on the epidemiology of melanoma and…
May 16, 2023

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