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The UK’s health care costs regulator is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending physicians turn to three new generation anticoagulants rather than commonly-used warfarin or aspirin. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training.
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Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More
Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
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
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
The FDA has warned two more compounding pharmacies for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training. 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. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. Read More