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Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
After an exhaustive review, the FDA found no clear evidence of higher cardiovascular risks for diabetic patients taking olmesartan, and declined to set new restrictions on use of the widely-prescribed hypertension drug. Read More
European regulators are advising drugmakers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements, and serious violations will face EU Phramacovigilance Risk Assessment Committee (PRAC) review. Read More
The FDA expects manufacturers of genetically engineered products that could be harmful if released into the wild to submit environmental assessments (EAs) along with their biologics applications. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
The FDA said Friday it would require a warning label on all testosterone products detailing the general risks of developing blood clots in the veins. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More