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The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More
The biosimilars market could exceed $390 billion in value over the next five years, but only if nations improve the competitive landscape, according to a new market analysis. Read More
Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease. Read More
Actavis received a setback in its quest to market a generic version of Lialda following a district court’s decision upholding Shire’s patent covering the ulcerative colitis drug. Read More
An FDA audit of Indian drugmaker Lupin revealed four potential violations in two 483s at two of its production facilities, the company admitted in a note to the Bombay Stock Exchange Tuesday. Read More
To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The World Health Organization is calling for stricter enforcement of private vaccine management regulations in China to mirror the tight controls the country has over its public vaccine distribution system. Read More
Japan’s Ministry of Health, Labour and Welfare has approved Biocon’s insulin glargine, the eighth biosimilar backed by the regulator since 2009. Read More