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Jan 29, 2024
AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive...
Jan 29, 2024
Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab). The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03...
Jan 29, 2024
Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with...
Jan 28, 2024
Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA...
Jan 26, 2024
AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore. The investment will add 24,000L of biologics drug-substance capacity to AbbVie’s manufacturing network. The expansion intends to support current products and emerging...
Jan 25, 2024
A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory bowel disease who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who...
Jan 25, 2024
Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE). Dupixent® is the first and only medicine approved in the US to treat these...
Jan 25, 2024
Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion Korean won) annual revenue in 2023 for the first time in the company’s history. This was due to the 8% growth in revenue from new product launches and...
Jan 24, 2024
A study published in JAMA Dermatol shows that rituximab had positive short-term efficacy and safety when compared to a standard corticosteroid regimen for patients with pemphigus.
Jan 24, 2024
The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab). It is indicated to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer,...
Jan 24, 2024
Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review. On 19...
Jan 23, 2024
WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs). Under the agreement, WuXi will be Celltrion’s primary service provider for its...
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