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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
A federal judge has tossed out some conspiracy claims brought against Abbott and its spinoff AbbVie over an alleged coupon scheme to boost sales of their branded arthritis drug Humira and testosterone therapy AndroGel. Read More
Pfizer and Ranbaxy have asked a federal judge to follow his own precedent and dismiss all remaining class-action lawsuits alleging the companies colluded to delay generic versions of Pfizer’s blockbuster cholesterol drug Lipitor. 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
A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More
Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More
A Pennsylvania jury last week ruled that Takeda must pay more than $2 million for downplaying bladder cancer risks of its diabetes drug Actos, a verdict one legal expert believes could embolden other plaintiffs to move forward with their lawsuits. Read More
A federal judge has dismissed to a local court a lawsuit alleging AstraZeneca negotiated illegal pay-for-delay settlements with generic firms to keep versions of its heartburn drug Nexium off the market.
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