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Buyers of heartburn drug Nexium are seeking an injunction against Ranbaxy and AstraZeneca in pay-for-delay litigation, arguing that their motion is supported by a recent Second Circuit ruling upholding an injunction requiring Actavis to keep an older version of Alzheimer’s drug Namenda on the market. Read More
ISPE’s Quality Metrics Pilot Program shows that it’s feasible for drugmakers to collect and submit a standardized set of metrics data to the FDA, but not without considerable cost, a final report on phase one of the pilot concludes. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials. Read More
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More