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On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab).  The results came from a double blinded, randomised, single dose study which asses...

Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab).  The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with sta...

On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma.  The target action date is set for 22 August 2024.  Priority review was granted following data from a combined Ph 1 |...

On 21 February 2024, the US Patent Trial and Appeal Board (PTAB) entered an adverse judgment against Regeneron in inter partes review proceeding IPR2023-00462.  The IPR was commenced by Celltrion and Samsung Bioepis in relation to Regeneron’s aflibercept formulation patent ...

On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.  ...

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients.  This approval increases dosing flexibility in patients on a weight-based dosing regimen.  TECVAYLI® w...

Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease.  Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.  ...

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) w...