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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
The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. 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
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