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Feb 22, 2024
AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell's portfolio notably includes GC012F a clinical stage chimeric...
Feb 22, 2024
On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar). Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis,...
Feb 21, 2024
Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested...
Feb 21, 2024
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...
Feb 21, 2024
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...
Feb 21, 2024
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...
Feb 21, 2024
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...
Feb 20, 2024
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...
Feb 20, 2024
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. ...
Feb 20, 2024
On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications. Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone...
Feb 20, 2024
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...
Feb 19, 2024
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...
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