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Oct 10, 2024
On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and...
Oct 10, 2024
On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab). Under an agreement with Alvotech entered in June 2024, STADA has...
Oct 9, 2024
On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the Taiwan Food and Drug Administration, for the first-line treatment of adult patients with unresectable...
Oct 9, 2024
On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. Felzartamab is an investigational...
Oct 9, 2024
On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody, for the treatment of patients with...
Oct 9, 2024
On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab). Pursuant to the agreement, Bio-Thera continues to be...
Oct 8, 2024
On 8 October 2024, MSD’s Keytruda® (pembrolizumab) and Astellas/Pfizer’s Padcev® (enfortumab vedotin) were approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a first-line combination treatment for unresectable or metastatic urothelial...
Oct 8, 2024
On 8 October 2024, Australia’s Therapeutic Goods Administration (TGA) approved Bayer’s Eylea® (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick”, for nAMD and diabetic macular oedema (DME). This follows approval of high dose Eylea® PFS (OcuClick) in Europe last...
Oct 8, 2024
On 8 October 2024, Teva Pharmaceuticals announced that the US FDA and European Medicines Agency (EMA) accepted Biologics Licence and Marketing Authorisation Applications, respectively, for its TVB-009P, biosimilar to Amgen’s Prolia® (denosumab). Both applications...
Oct 8, 2024
From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled their dispute regarding the validity of...
Oct 4, 2024
On 4 October 2024, Amgen filed a BPCIA complaint against Fresenius Kabi in the US District Court for the Northern District of Illinois (Eastern Division) asserting infringement of 33 US patents relating to denosumab and methods of its manufacture. The litigation...
Oct 4, 2024
On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare. The application proposes use of Enhertu® in adult patients with HER2 low...
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