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The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action. Read More
Reports of adverse drug reactions in China rose by less than 1 percent last year, compared with 2013, with injectables showing the biggest increase, data released by the China Food and Drug Administration shows. Read More
AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More
Canadian drugmaker Tekmira has halted recruitment of patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More
Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process. Read More