While still a long way from solving the problem of how to name biosimilars, a World Health Organization (WHO) expert group is looking at a hybrid proposal that straddles the fence between conflicting calls for unique or shared international nonproprietary names (INNs). Read More
Pfizer Inc., of New York, reported top-line data from two Phase III studies of irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small-cell lung cancer (NSCLC), neither of which met their primary objectives. Read More
Celsion Corp., of Lawrenceville, N.J., said the latest overall survival data from its posthoc analysis of the Phase III HEAT study of Thermodox, the firm’s heat-activated liposomal encapsulation of doxorubicin, in combination with radio frequency ablation (RFA) supported the continued clinical development in a prospective Phase III pivotal study, subject to regulatory review and agreement. Read More
Nearly 18 months after its launch by the FDA, the breakthrough therapy designation (BTD) is showing the potential to meet the agency’s stated goal of speeding the development and review of drugs that show early evidence of offering substantial improvement over existing therapies on a clinically significant endpoint. Read More
The drug-development standard that a pill is always better than a shot may not pull as much weight when it comes to treating allergies, and this could be true even when multiple injections are involved. Read More
Medigene AG is paying €4 million (US$5.5 million) in stock and could pay up to €5.875 million more in milestones to acquire newly formed start-up cancer immunotherapy firm Trianta Immunotherapies GmbH, which already has two clinical trials under way. Read More
Set to start its Phase III trial for antibacterial candidate plazomicin this quarter, Achagoen Inc. filed for a $74.8 million initial public offering (IPO), which, along with anticipated funding from the Biomedical Advanced Research and Development Authority (BARDA), could take the firm through top-line data, expected in the first half of 2017. Read More
The Patient-Centered Outcomes Research Institute (PCORI) responded to criticism about how it’s spending its research dollars with a reminder that its 10-year mandate is not just for comparative clinical effectiveness research (CER). Read More
Emergent Biosolutions Inc. of Rockville, Md., said the initial purchasers of their convertible senior notes offering have exercised in full their option to purchase an additional $35 million of the notes due 2021. Read More
Galectin Therapeutics Inc., of Norcross, Ga., and SBH Sciences Inc., of Natick, Mass., said they established Galectin Sciences LLC as a collaborative venture to investigate and develop small organic molecule inhibitors of galectin-3 for oral administration. Read More
