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A federal judge has tossed out UK-based Reckitt Benckiser Pharmaceuticals’ patent infringement lawsuit against BioDelivery Sciences International over its competing product to Reckitt’s Suboxone, ruling that the court didn’t have jurisdiction because BioDelivery’s drug has yet to be approved. Read More
The European Medicines Agency is pushing back against critics who accuse the agency of softening its commitment to clinical trials data transparency, saying there has been “absolutely no change in direction” in the agency’s efforts to make trial data more publicly available. Read More
International and U.S. authorities this week seized more than $31 million in potentially counterfeit and dangerous drugs and shut down more than 10,600 websites for peddling unapproved and substandard pharmaceuticals in the third annual international sweep of its kind. Read More
Manufacturers that are slow to report overpayments for drugs reimbursed through federal healthcare programs, such as Medicare or Medicaid, could face fines of $10,000 a day, under a proposed regulation — a rule that could cause major headaches for drugmakers trying to sort out complex government billing systems. Read More
Pfizer suffered a setback Tuesday in its efforts to defend itself against charges that a division of the company illegally slowed generic competition for one of its products. Read More
The FDA has approved Japanese drugmaker Takeda Pharmaceutical’s biologic injection Entyvio to treat adults with moderate to severe ulcerative colitis or Crohn’s disease. Read More
The FDA is developing mathematical algorithms that will compare generic drugs to their branded counterparts, according to an agency grant announcement. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
The FDA has issued a warning letter to Sanum-Kehlbeck for using the same equipment to produce penicillin and non-penicillin products and other quality violations. Read More