Melinta Therapeutics Inc.'s $67 million equity financing will allow the company to finish the half-completed, second phase III trial for acute bacterial skin and skin structure infections with new fluoroquinolone antibiotic delafloxacin – the first in that class for 14 years – and file for FDA approval in early 2016 while moving ahead with other efforts, CEO Mary Szela said. Read More
New head-to-head data proving biosimilar versions of some of the world's bestselling rheumatoid arthritis (RA) therapies are as safe and effective as their branded counterparts are being presented by Merck & Co. Inc., its partner Samsung Bioepis Co. Ltd. and competitors at the European League Against Rheumatism Annual Congress this week. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) struck out a second time in its challenge of a 2013 rule that extended the FTC's antitrust oversight of drug and diagnostic makers. Read More
LUCKNOW, India – An Indian government-funded drug research institute plans to set up a biopharma industry incubation center to attract entrepreneurs in northern and central India, areas that are home to a number of high-quality research laboratories but are in dire need of bioclusters. Read More
TOKYO – A new initiative in Japan aims to bring together the research resources of multiple stakeholders, including a handful of multinational biotech companies, to bear on the fight against some insidious neglected diseases. Read More
Genentech, of South San Francisco, a member of the Roche Group, said the FDA granted breakthrough therapy designation to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. Read More
Bluebird Bio Inc., of Cambridge, Mass., said the NIH Recombinant DNA Advisory Committee (RAC) completed its public review of the HGB-208 pediatric study protocol for Bluebird's LentiglobinBB305 product candidate in beta-thalassemia major and recommended the delay of the study in the U.S. for one to two years. Read More
