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Jul 8, 2024
On 8 July 2024, Ligand Pharmaceuticals and Austrian-based APEIRON Biologics announced that Ligan will acquire APEIRON for US$100m. Ligand will also pay APEIRON shareholders additional amounts of up to US$28m based on future commercial and regulatory events. The...
Jul 7, 2024
On 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic...
Jul 5, 2024
On 5 July 2024, Roche announced that the FDA has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6 mg) for nAMD, diabetic macular oedema and macular oedema following retinal vein occlusion. Roche reports that the product is the first PFS with an FDA-approved...
Jul 4, 2024
On 4 July 2024, Celltrion announced that it received final approval from the European Commission for an additional dosing regimen and dose increase for Remsima SC® (infliximab). The approval comes almost a month after the CHMP issued a positive opinion for the new...
Jul 3, 2024
Novo Nordisk’s weekly injection insulin Icodec is reported as nearing approval in India following a 19 June 2024 recommendation by the Subject Expert Committee under India’s drug controller to permit the import and sale of the drug. This news follows the approval of...
Jul 3, 2024
On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood...
Jul 2, 2024
On 2 July 2024, Eli Lilly announced that the US FDA has approved its KisunlaTM (donanemab-azbt) for early symptomatic Alzheimer’s Disease (patients with mild cognitive impairment or mild dementia stage of disease). Once-monthly Kisunla is the first amyloid...
Jul 2, 2024
Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical...
Jul 2, 2024
According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract...
Jul 2, 2024
Fresenius Kabi has launched its subcutaneous formulation of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab), in the United States. This new formulation provides patients with primary immunodeficiency diseases a convenient alternative to...
Jul 2, 2024
Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma. The resubmission aims to address “approvability deficiencies”...
Jul 2, 2024
On 12 July 2023, Samsung Bioepis UK Limited commenced proceedings against Janssen Biotech Inc in the High Court of Justice of England and Wales seeking to invalidate the UK counterpart patent of European Patent No. EP 3 883 606. Janssen’s patent relates to the use of...
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