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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
Manufacturers of botulinum toxin intended to erase facial wrinkles should develop safeguards that reduce the risk of inadvertent injection and other safety issues with the product, according to the FDA. Read More
Drugmakers want the FDA to harmonize new draft guidance on conducting clinical trials for resistant pneumonia treatments with EU regulations to ease development burdens. 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 will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to a new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More