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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....
Jun 13, 2024
On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma. A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of...
Jun 13, 2024
On 13 June 2024, at the Annual European Congress of Rheumatology, Celltrion announced positive Phase III results for CT-P47, a biosimilar referencing RoActemra®, in patients suffering from moderate-to-severe rheumatoid arthritis. The Phase III comparative clinical...
Jun 12, 2024
On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours. The trial (NCT06451497) is evaluating ZM008 alone and in combination with...
Jun 11, 2024
On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion. Ono plans to leverage Deciphera's oncology research and development capabilities, as well as its sales presence in...
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