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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
The European Medicines Agency is urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic profiles as the gold standard in proving efficacy similarity to their reference products. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More