We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A Las Vegas jury has found Takeda Pharmaceutical not liable for the bladder cancer of two women who took the Japanese drugmaker’s diabetes drug Actos, marking the firm’s fifth legal victory out of six cases that have gone to trial so far. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said Thursday. 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
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. 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
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