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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
The UK’s healthcare cost watchdog has updated its methods for reviewing biosimilar applications in anticipation of the products’ increasing availability in the country. Read More
An Indian clinical trial advisory body has recommended exempting some drugs, including those to treat cancer and hepatitis C, from a requirement that manufacturers conduct local Phase III trials as a condition of marketing approval. Read More
Drugmakers could end up paying millions of dollars on collection and disposal programs for unwanted drugs nationwide if industry groups aren’t able to stop a California county ordinance. Read More
Drug recalls increased for the third straight year, with companies pulling six percent more products in 2014 than the year before and foreign particles being the top culprit. Read More
Johnson & Johnson subsidiary Janssen has launched a human clinical trial of its experimental Ebola vaccine in the UK, with much larger clinical trials expected to start this spring in the U.S. and Africa. Read More