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Amgen
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Biosimilars
Swiss generic and biosimilar medicines company Sandoz today announced that Wyost (denosumab) and Jubbonti (denosumab) are available to patients in the USA starting today. 2 June 2025
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Latest News & Features of interest to Amgen
Pharmaceutical
The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 14 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Biotechnology
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Pharmaceutical
Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced new data from the pivotal AUGMENT-101 trial of Revuforj (revumenib), the company’s first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML). 12 June 2025
Biotechnology
US antivirals specialist Gilead Sciences’ Kite, unit today presented the latest results that demonstrate a 79% overall response rate (ORR) and 74% overall survival (OS) at six months follow-up, for Yescarta (axicabtagene ciloleucel) as second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL), from the largest real-world study in this patient population. 12 June 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis today presented the long-term safety data of Epysqli (eculizumab; SB12), a biosimilar to AstraZeneca’s Soliris, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15. 12 June 2025
Latest In Brief for Amgen
Biotechnology
South Korea’s LigaChem Biosciences has signed two antibody licensing agreements with US biotech NovaRock Biotherapeutics, reports Korea Biomedical Review. 12 June 2025
Latest Relevant Ones To Watch News
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
16 May 2025
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