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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 receiv...

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 patients...

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 sales exp...

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.  

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, glioma, epi...

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 J...

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 projects,...

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential res...

A Bristol Myers Squibb (BMS) study published in the Journal of Clinical Oncology concluded that Opdivo® (nivolumab) plus chemotherapy did not significantly improve progression-free survival versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated...

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursem...