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Dr. Reddy’s and Hospira have asked a federal appeals court to reconsider a patent infringement ruling regarding Eli Lilly’s cancer drug Alimta (permetrexed). Read More
States that expanded their Medicaid programs have seen significantly higher numbers of prescriptions of the opioid addiction treatment buprenorphine, according to an analysis by the Urban Institute, a policy think tank in Washington, D.C. Read More
The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More
The FDA issued warning letters to four firms for a variety of violations, including testing issues, invalidating out-of-specification test results without justification and the use of untested water in manufacturing. Read More