Assuming an agreement between the House and the Senate halts a government shutdown, the FDA's Oncologic Drugs Advisory Committee is slated to meet Tuesday to review Pfizer Inc.'s Sutent (sunitinib) and Novartis AG's Afinitor, both of which are seeking expanded approval for pancreatic neuroendocrine tumors (pNET). Read More
Two months after submitting a U.S. Biologics License Application for VEGF Trap-Eye (afilbercept ophthalmic solution) in wet age-related macular degeneration, Regeneron Pharmaceuticals Inc. and Bayer HealthCare began Phase III trials in a new indication, diabetic macular edema (DME). Read More
Thousand Oaks, Calif.- based biotech giant Amgen Inc. has taken several steps to expand its operations in Brazil: On Friday the company announced it acquired privately held Brazilian drugmaker Bergamo and reacquired the rights to several of its own products in Brazil. Read More
StemCells Inc., of Palo Alto, Calif., discontinued a Phase Ib trial of HuCNS-SCA human neuronal stem cells in neuronal ceroid lipofuscinosis (NCL) due to lack of patient accrual. Phase I safety studies were completed in 2009 in six patients with advanced NCL. The Phase Ib trial was to evaluate the therapy in six early stage patients. However, no eligible patients have been found after six months of searching. Read More
Polaris Group, of San Diego, said preclinical data for ADI-PEG-20, pegylated arginine deiminase, showed that it may effectively treat acute myeloid leukemia, glioblastoma multiforme and bladder cancer. In those cancers, hypermethylation of a promoter gene for arginosuccinate synthetase leads to a deficiency of the enzyme, which causes tumors to be reliant on externally supplied arginine. ADI-PEG-20 degrades arginine, depriving the tumor of that nutrient. Polaris is preparing to begin pivotal Phase III trials of the drug in hepatocellular carcinoma. Read More
Two genomewide association studies by multinational teams have identified five new common variants that are associated with an increased risk of Alzheimer's disease, doubling the number of known risk loci. Read More
Like thousands of other federal workers, folks at the FDA and SEC kept their fingers crossed Friday, hoping the House and Senate would come to terms on a spending bill in time to keep the government from shutting down. Read More
Idenix Pharmaceuticals Inc., of Cambridge, Mass., and Sangamo BioSciences Inc., of Richmond, Calif., have priced public offerings expected to raise more than $50 million for each company. Read More
