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733,539 Results for "kinetix pharmaceuticals inc merged with amgen see amgen".
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Regulatory
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
October 18, 2024
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2 min read
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Tristan Manalac
Pipeline
Amgen Whets Investors’ Appetites for MariTide Obesity Data by End of Year
While Amgen’s third-quarter financial results on Wednesday were “somewhat uneventful,” investors continue to be focused on the highly anticipated MariTide Phase II results slated for late 2024, according to BMO Capital Markets analyst Evan Seigerman.
October 31, 2024
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2 min read
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Tristan Manalac
Legal
Amgen Faces Class Action Lawsuit for Allegedly Hiding $10.7B Tax Bill From Investors
Amgen’s motion for dismissal was denied after a New York judge agreed the company did not sufficiently disclose to shareholders back taxes and penalties owed to the Internal Revenue Service.
October 2, 2024
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2 min read
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Tristan Manalac
Legal
Amgen Gets Legal Win in Eylea Patent Row With Regeneron
Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
September 24, 2024
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2 min read
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Tristan Manalac
Phase III
Amgen Scores Late-Stage Wins in Eczema and Myasthenia Gravis, But Analysts See Mixed Results
Jefferies analyst Michael Yee in a note to investors called rocatinlimab’s atopic dermatitis data “modest,” noting that the OX40 receptor blocker “came in at the lower end of efficacy and expectations,” but found Uplizna’s performance in generalized myasthenia gravis “better than expected.”
September 25, 2024
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2 min read
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Tristan Manalac
Obesity
Amgen Plans Phase III Program for Next-Gen Obesity Drug Targeting Liver and Kidney Diseases
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
September 5, 2024
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2 min read
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Tristan Manalac
Business
Stada Bags European Rights from Alvotech to Biosimilar of Amgen Blockbusters
Stada announced Tuesday it has secured European rights from Alvotech to a clinical-stage biosimilar of Amgen’s blockbuster bone drugs Prolia and Xgeva.
June 11, 2024
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2 min read
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Nick Paul Taylor
Job Trends
AMGEN TO PRESENT INNOVATIVE RHEUMATOLOGY RESEARCH AT EULAR 2024
Amgen (NASDAQ:AMGN) today announced the presentation of data across its diverse portfolio and pipeline at the European Alliance of Associations for Rheumatology’s (EULAR) 2024 Congress, June 12-15 in Vienna.
June 12, 2024
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28 min read
Drug Development
Amgen Phase III Win Positions Uplizna for Label Expansion in Rare Autoimmune Disease
Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.
June 6, 2024
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2 min read
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Tristan Manalac
Drug Development
Amgen Axes Development of Early-Stage Bispecific T-Cell Engager for Solid Tumors
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
July 10, 2024
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2 min read
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Tristan Manalac
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