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Jun 19, 2024
On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows...
Jun 18, 2024
On 18 June 2025, AbbVie announced that the FDA approved its Skyrizi® (Risankizumab) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease. AbbVie’s Skyrizi® (risankizumab) was approved in November 2023 by the Korean Ministry of Food...
Jun 18, 2024
On 18 June 2024, Alvotech announced that it has entered into an agreement with Advanz Pharma in relation to the commercialisation in Europe of Alvotech’s AVTO6 and AVT29, biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively. ...
Jun 18, 2024
Samsung Biologics has renegotiated its manufacturing agreement with Baxter Healthcare, increasing Baxter's payments to Samsung to over US$223 million through the end of 2034, up from an initial US$15m. The specifics of the products Samsung will manufacture for Baxter...
Jun 17, 2024
A Phase 3 study sponsored by Novo Nordisk and published in Research and Practice in Thrombosis and Haemostasis found that once-daily concizumab prophylaxis significantly improved patient-reported outcomes (PROs) in individuals with hemophilia A or B with inhibitors...
Jun 17, 2024
As previously reported, on 6 May 2024, the United States District Court for the District of Delaware refused to grant Alexion preliminary injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for...
Jun 17, 2024
On 17 June 2024, Merck (known as MSD outside the US and Canada) announced that the US FDA has approved its anti-PD-1 therapy, Keytruda® (pembrolizumab) in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial carcinoma. This is the...
Jun 15, 2024
On 15 June2024, Ophthalmology and Therapy published the results of a Samsung Bioepis-sponsored study which assessed the analytical similarity between Samsung Bioepis’ aflibercept biosimilar, SB15, and Regeneron’s Eylea® (aflibercept) sourced from the US and EU. The...
Jun 14, 2024
On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for nAMD and DME. High dose Eylea® has previously been approved in multiple countries including the US (August 2023 –...
Jun 14, 2024
On 14 June 2024, the Patent Trial and Appeal Board (PTAB) issued a final decision in Samsung Bioepis’ Inter Partes Review Proceeding (IPR2023-00442) relating to Regeneron’s US Patent No. 10,130,681 (‘681 patent) covering methods of treatment involving Eylea®...
Jun 13, 2024
On 13 June 2024, the Korea Herald reported that Celltrion's Steqeyma (CT-P43), biosimilar to J&J's Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®. No launch date has been...
Jun 13, 2024
On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide. Originator Novo Nordisk supplies liraglutide as Victoza® in EU which is indicated for the treatment of type 2 diabetes....
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