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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 ...
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.
Singer and Bloom acknowledge that the FDA added clozapine to the REMS program in 2015 "because of a rare side effect (less than 3 percent frequency) called agranulocytosis, a reversible but life ...
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.
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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.
Celgene Announces $600 Million Accelerated Share Repurchase Program SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NAS: CELG) announced today that it has entered into an accelerated share ...