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Oct 22, 2024
On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal. That appeal concerns a September 2024 decision of the US...
Oct 22, 2024
On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list. The request aims to prevent compounding pharmacies from producing...
Oct 22, 2024
On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen's Stelara®. The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and...
Oct 21, 2024
In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol). On 21 October 2024, Xbrane announced it reached...
Oct 21, 2024
On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established...
Oct 21, 2024
On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection pre-filled syringe, 45 mg/0.5 mL solution for injection pre-filled syringe and 5 mg/1 mL...
Oct 18, 2024
On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME). The results were presented at the American Academy of...
Oct 18, 2024
On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its September 2024 intracycle meeting. This included consideration of proposals for broad Pharmaceutical Benefits Scheme (PBS) listings for PD-(L)1 inhibitors,...
Oct 18, 2024
On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or...
Oct 17, 2024
At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Novo Nordisk’s Alhemo® (concizumab) for routine prophylaxis of bleeding in patients of 12 years of age...
Oct 17, 2024
On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations. Tyenne® is indicated for the treatment of several inflammatory and immune diseases, including...
Oct 17, 2024
At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord HealthCare’s, Imuldosa® (DMB-3115) and Absimky® (DMB-3115), biosimilars to Janssen’s Stelara® (ustekinumab). Both...
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