Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2026
France recalls Tavneos batches after deaths linked in Japan
Recall announced
France's medicine safety agency ANSM said the recall of all Tavneos batches available in France would begin on August 19, after the drug, made by U.S. biotech firm Amgen and sold by partner companies worldwide, was linked to 20 deaths in Japan. The European Commission had revoked the drug's marketing authorisation earlier in the month.
Company response
Recall — France's medicine safety agency ANSM
"The recall of all batches available in France will begin on August 19," France's medicine safety agency ANSM said in a statement.
Source excerpt
The European Commission revoked the drug's marketing authorisation earlier this month because "the benefits are no longer proven to outweigh its risks".
Kissei Pharmaceutical, which sells the drug in Japan, said in May that 20 deaths had been reported among people using the it since 2022.
A drug called Tavneos used to treat rare autoimmune diseases will be pulled from the shelves in France, the country's medicine watchdog said Wednesday, after it was linked to 20 deaths in Japan.
2022
Lindis Biotech sues Amgen over patents
Lawsuit filed
Lindis Biotech filed a complaint against Amgen in the District of Delaware, alleging that Amgen infringed three patents relating to an immunotherapy regimen. The complaint seeks a declaration of infringement and damages, among other relief; the allegations are not presented as a court determination.
Source excerpt
The plaintiffs are seeking a declaration that Amgen infringed upon the ‘421, ‘158 and ‘149 patents, actual damages, interest, attorney’s fees and costs, and other relief.
On Monday, Lindis Biotech, GmbH filed a complaint in the District of Delaware against Amgen Inc. for allegedly infringing upon their patents for an immunotherapy regimen that is more effective, and less harmful to the human body, than chemotherapy or radiation treatments.
2021
Amgen files Supreme Court petition in patent dispute
Lawsuit filed
Amgen Inc. and its subsidiaries filed a petition for certiorari with the U.S. Supreme Court against Sanofi Aventisub LLC, Regeneron Pharmaceuticals Inc. and Sanofi-Aventis US, LLC. The petition concerns the written-description requirement for patents and the level of detail that requirement demands.
Source excerpt
On Monday a petition for certiorari was filed to the Supreme Court of the United States by Amgen Inc. and its subsidiaries against Sanofi Aventisub LLC, Regeneron Pharmaceuticals Inc. and Sanofi-Aventis US, LLC.
2012
Off-label promotion, kickbacks, and pricing settlement
Amgen pleaded guilty to a federal charge and paid $762 million to resolve criminal and civil allegations concerning promotion of medicines for unapproved uses, improper inducements, and false pricing submissions.