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India’s drug pricing authority wants manufacturers of fixed-dose combination products that are less than four years old to confirm that the products have been approved and are not prohibited under the country’s drug laws. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
The FDA approved Impax Labs’ Parkinson’s disease drug Rytary after the drugmaker agreed to not use a troubled manufacturing facility for production. Read More
Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this week, but industry and patient groups contend the regulatory pathway still has many potholes, including unanswered questions on naming, labeling, testing requirements and interchangeability of the products. Read More
European Medicines Agency advisors have recommended approval of Newron and Zambon Pharmaceuticals’ Parkinson’s disease drug Xadago in combination with levodopa or other therapies for mid- to late-stage patients experiencing motor fluctuations. Read More