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The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable drugs, but questions remain about the program’s transparency and how the market would be divided among competing partnerships. Read More
Foreign companies seeking to market novel drugs in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape. Read More
Overly zealous national and local healthcare funding schemes have put the UK far behind other industrialized countries in providing patients access to the latest drug therapies, an industry report concludes. 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
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. Read More
Clinical trial sponsors and contract research organizations incur the majority of good clinical practice violations, a European Medicines Agency panel reports. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More
Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. Read More
An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides. Read More
Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.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