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Australian doctors and academics are asking their colleagues worldwide to ban all meetings with pharmaceutical sales reps for a year in a bid to reduce concerns over inappropriately pushed medications. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
Endo International will acquire Auxilium Pharmaceuticals in a move that is expected to bolster Endo’s pipeline of testosterone products, which FDA advisors have recently scrutinized. Read More
Canadian generics firm Apotex has asked the full U.S. Court of Appeals for the Federal Circuit to rehear a case alleging brandmaker UCB’s hypertension drug Univasc infringed on one of Apotex’s patents. Read More
A federal judge has dismissed some claims in a case alleging Teva and Pfizer-subsidiary Wyeth forged an anticompetitive agreement to delay generic competition on Wyeth’s antidepressant Effexor XR. Read More
Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More
Generics firm Par Pharmaceuticals has agreed to pay Salix Pharmaceuticals $100 million to settle a patent infringement lawsuit over its version of Salix’s heartburn drug Zegerid. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More