Green-lighted by the FDA, Halozyme Therapeutics Inc. plans to start by the end of 2016's first quarter the phase III push with PEGPH20, a pegylated form of the firm's recombinant human hyaluronidase, in patients with metastatic pancreatic cancer – and the trial design, which could allow for approval based on either progression-free survival (PFS) or overall survival (OS) endpoints, has analysts enthused. Read More
Responding to its eighth FDA warning letter in seven years, Hospira Inc. has committed to working with a third-party consultant to conduct a comprehensive assessment of its manufacturing, laboratory and quality operations. Read More
In the wake of last month's big win for diehard amyloid beta theorists everywhere, Alzheon Inc.'s $10 million series A round to advance its Alzheimer's disease candidate toward pivotal testing seems downright modest; in fact, the small biotech could easily have raised more. Read More
Washington-based gene therapy developer Regenxbio Inc. has shored up key intellectual property rights and relationships supporting its preclinical therapies for the rare genetic diseases Hurler and Hunter syndromes, executing two exclusive new license and research agreements with the universities of Pennsylvania and Minnesota. Read More
SHANGHAI – Shanghai-based Ark Biosciences Inc. has received financial backing, the amount undisclosed, to usher its lead candidate through phase II trials in Australia and possibly other sites. Ark is developing AK0529, an asset licensed from Roche AG to treat respiratory syncytial virus (RSV), a significant cause of death for children younger than 5 and the elderly. Read More
LONDON – Stock exchanges, private equity firms and venture capitalists are calling for Europe to emulate the U.S. emerging growth company designation to make it easier for small companies to list on public markets, following years of decline in the capital raised through IPOs. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said grazoprevir/elbasvir, an investigational single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new breakthrough therapy designations from the FDA for the treatment of patients with chronic HCV genotype 4 infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end-stage renal disease on hemodialysis. Read More
Discoverybiomed Inc., of St. Louis, was awarded a $1.61 million phase 2 Small Business Innovation Research grant award from the National Institutes of Health and its National Institute of Diabetes, Digestive and Kidney Diseases to develop first-in-class small-molecule drugs to fight multiple disease abnormalities caused by high blood sugar (hyperglycemia) and high blood fat such as metabolic syndrome, type 2 diabetes mellitus and obesity. Read More
Armagen Inc., of Calabasas, Calif., said its investigational new drug application for enzyme replacement therapy candidate AGT-181 for the treatment of Hurler syndrome was accepted by the FDA. Read More
