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Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, its third recall in less than a year. Read More
Pfizer has agreed to pay $325 million to private insurers to settle a decade-old lawsuit alleging the drug giant illegally marketed the epilepsy drug Neurontin for off-label purposes. 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 FDA is developing mathematical algorithms that will compare generic drugs to their branded counterparts, according to an agency grant announcement. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Both sides in a patent lawsuit involving the drug Suprep are asking a federal appeals court to reconsider its opinion in the case, saying the court set a dangerous precedent for future Hatch-Waxman patent suits because it recognized infringement for unapproved uses and clouds the definition of “patient” when it comes to the patent claim. 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
Pfizer suffered a setback May 20 in its efforts to defend itself against charges that a division of the company illegally slowed generic competition on the muscle relaxant Skelaxin. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More