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Eight African nations have signed up to participate in the second European & Developing Countries Clinical Trials Partnership, with a ninth expected to follow suit soon. Read More
Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More
Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
The European Medicines Agency has selected the first two drug candidates for inclusion in a pilot project, known as adaptive licensing, that aims to speed patient access to new treatments. Read More
The FDA has added three new pathogens to the list of infectious agents that drugmakers can target to receive accelerated approval and extended market exclusivity under the agency’s program aimed at antibiotic-resistant infections. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More