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In 2018, Celgene was at the top of a list of companies that the FDA identified as refusing to release samples to competitors to create generics. [53] Generic manufacturer Lannett Company initiated antitrust litigation that accused Celgene of using its REMS for THALOMID (thalidomide) to violate the anti-monopolization provisions of the Sherman ...
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Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma. [3] [7] [8]The most common side effects include cytokine release syndrome (CRS), infections, fatigue, musculoskeletal pain, and a weakened immune system (hypogammaglobulinemia).
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
In June, the company announced a 10-year partnership with Celgene valued at $1 billion. [9] As part of the deal Celgene will pay Juno $150 million and acquire 9.1 million new Juno shares (valued at $93, existing Juno shares rose 26% to $58.38). Celgene will gain the right to sell Juno's therapies around the world.
In 2016, Impact Biomedicines acquired the rights to fedratinib from Sanofi and continued its development for the treatment of myelofibrosis and polycythemia vera. In January 2018, the drug's rights were transferred to Celgene with their purchase of Impact Biomedicines. [9] Fedratinib was approved for medical use in the United States in August 2019.
Radiofrequency Echographic Multi Spectrometry (REMS) is a non-ionizing technology for osteoporosis diagnosis and for fracture risk assessment. REMS processes the raw, unfiltered ultrasound signals acquired during an echographic scan of the axial sites, femur and spine. The analysis is performed in the frequency domain.
Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions).