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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...
Feb 19, 2024
According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement. The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following:
Feb 19, 2024
On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab). These contracts...
Feb 16, 2024
Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. The announcement states that Xolair® is the first FDA-approved...
Feb 16, 2024
Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy. Approval followed...
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