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A deluge of warning letters to compounding pharmacies appears to have jolted the industry into taking FDA enforcement more seriously, quality experts tell DID. Read More
The European Commission approved Roche’s cancer drug Avastin in combination with chemotherapy to treat women with recurring ovarian cancer that is resistant to platinum-containing chemotherapy. Read More
A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned. Read More
European regulators have granted Alexion Pharmaceuticals’ blood disease therapy Soliris orphan drug designation for the treatment of myasthenia gravis, putting the company on its way toward a third indication for the product. Read More
AstraZeneca has sued India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
The European Medicines Agency wants to bring its policy on accessing drug safety reports in line with pharmacovigilance legislation, which aims to simplify reporting and increase data sharing among international organizations. Read More
Generics manufacturer Akorn must sell its rights to a pending ANDA for the tuberculosis drug rifampin before it can complete its $324 million acquisition of VersaPharm, the Federal Trade Commission said. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More