The ghost of anemia drugs present could haunt Affymax Inc.'s peginesatide injection when it comes up for discussion Wednesday at a meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC). Read More
GLASGOW, SCOTLAND – The global capacity for manufacturing biologics is growing, but most facilities are controlled by a few major companies and used for their own products, creating difficulties for smaller biotechs with products that are approaching commercialization. Read More
Metabotropic glutamate receptor functioning, and malfunctioning, has been implicated in a number of brain disorders, including schizophrenia, anxiety and autism. Read More
Reaction was mixed on Monday when Regeneron Pharmaceuticals Inc. reported two-year data suggesting that newly approved Eylea (aflibercept) injection in wet age-related macular degeneration (AMD) offered only modest benefit in a head-to-head comparison with market-leading VEGF inhibitor Lucentis (ranibizumab, Genentech Inc./Roche AG). Read More
• PharmaGap Inc., of Ottawa, Ontario, completed its previously announced private offering of stock and warrants, raising C$634,210 (US$625,392) through the sale of 9.06 million units priced at C7 cents apiece. Read More
• DiaMedica Inc., of Winnipeg, Manitoba, reported results of a preclinical study in Type I diabetes showing that chronic administration of lead compound DM-199 delayed the autoimmune attack, preserved beta cell mass and demonstrated a 12-fold increase in circulating C-peptide levels – the primary endpoint in most Type I diabetes trials – in the non-obese diabetic animal model. The increase in C-peptide levels reflected improved insulin secretion and suggested the ability of DM-199 to stabilize and preserve C-peptide in peripheral blood, according to the company. Read More
• Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it filed an investigational new drug application for SPI-014 (formerly called Renazorb), a second-generation lanthanum-based nanoparticle phosphate binding agent that has the potential to treat hyperphosphatemia in patients with Stage V chronic kidney disease, or end-stage renal disease. The company anticipates starting Phase I studies as soon as possible after FDA review. Read More
