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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
Gilead Sciences has signed an exclusive deal with CVS Health Corp. to cover its hepatitis C drugs Sovaldi and Harvoni, a move that follows rival AbbVie’s exclusive deal late last month with pharmacy benefit giant Express Scripts to cover its combination therapy. Read More
Ranbaxy’s 180-day marketing exclusivity period for its version of Novartis’ blockbuster hypertension drug Diovan ended yesterday, prompting a flood of generic competition. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More