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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
Eagle Pharmaceuticals is objecting to the FDA’s decision to grant orphan drug Bendeka only three years of exclusivity instead of the full seven years and says it may take action. Read More