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The International Council for Harmonization has identified the key scientific issues pediatric drug developers must address early on to improve the prospects for a drug’s approval later in the development process, in a draft that updates a 16-year-old efficacy guideline. Read More
NHS England and the UK’s National Institute for Health and Care Excellence have unveiled a proposal for an abbreviated review process for therapies identified as having exceptional value based on cost and effectiveness. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
Prospects look somewhat grim for the life sciences industry in the UK, regardless of whether the country decides to completely divorce itself from the EU or do a “soft exit,” a think tank says. Read More
Teva Pharmaceuticals is reserving roughly $520 million to settle bribery allegations across three countries, according to the company’s latest earnings report. Read More
The EMA is revising nearly decade-old guidelines on first-in-human trials after a patient died in a French study earlier this year to offer drugmakers guidance on risk management. Read More