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Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections. Read More
British regulators are seeking industry input to create a “white list” of prescription drugs that should be exempt from an EU requirement to verify the authenticity of products, as well as a “black list” of nonprescription drugs that must bear the verification. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More
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Drugmakers want the FDA to harmonize new draft guidance on conducting clinical trials for resistant pneumonia treatments with EU regulations to ease development burdens.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