After decades of foot-dragging, the FDA has put drugmakers on notice that greater inclusion in clinical trials – balanced gender enrollment, more cultural diversity and wider age spans – is coming. Read More
LONDON – The EMA has taken the next step in implementing new clinical trials transparency rules, setting out guidance for the public on accessing documents. Read More
SHANGHAI – Chinese venture capital (VC) investors with funds in Chinese yuan used to have a tough time getting their cash out of the country to make cross-border investments. That is no longer the case. Changes to the rules make it much easier for domestic VCs to convert their renminbi (RMB) funds into foreign currency. Read More
A group of five papers published in the Nov. 27, 2014, issue of Nature has deepened the understanding of how immuno-oncology works, and what might improve it, in several ways. Read More
The approval this fall of Merck & Co. Inc.'s lauded Keytruda (pembrolizumab) for melanoma – well ahead of its Oct. 28 PDUFA date – opened the door for the promising class of programmed cell death-1 (PD-1) inhibitors, and represented another stride in the steady march of immunotherapy in cancer. Read More
BOGOTA, Colombia – A new partnership aims to strengthen cancer registries throughout the region, as part of an effort to improve treatments and outcomes. Read More
Carsgen, a Shanghai-based company developing chimeric antigen receptor T-cell therapies for cancer, completed a series A financing of undisclosed value, led by the private equity fund BVCF. Read More
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the National Institute of Health and Clinical Excellence (NICE) Highly Specialized Technologies Evaluation Committee has reaffirmed the clinical value of the company's Soliris (eculizumab) for the treatment of atypical hemolytic uremic syndrome and the lack of other effective therapies, and has issued a recommendation that it be nationally commissioned for all patients suffering from the severe and life-threatening genetic disorder. Read More
Ablynx NV, of Ghent, Belgium, disclosed positive results from the phase I trial to demonstrate bioequivalence between the liquid and lyophilized formulations of caplacizumab, Ablynx's anti-von Willebrand factor nanobody developed for the treatment of acquired thrombotic thrombocytopenic purpura. Read More
Eli Lilly and Co., of Indianapolis, said the European Commission granted marketing authorization for Trulicity (dulaglutide) solution for injection. Trulicity, a GLP-1 receptor agonist, is a once-weekly, injectable solution designed to improve glycemic control in adults with type 2 diabetes. Read More
A team from Washington University in St. Louis and Roche AG subsidiary Genentech Inc. has identified a genetic mutation that predisposes to late-onset Alzheimer’s disease (AD). Read More
