Paxvax Inc.’s just-begun Phase III effort with PXVX0200 could lead to the first cholera vaccine approved for marketing in the U.S., and the company could become the first to gauge the resale value of the FDA’s priority review voucher (PRV), an incentive put in place six years ago to boost work against neglected tropical diseases. Read More
The FDA approved Celgene Corp.’s Abraxane Friday for use in pancreatic adenocarcinoma. It’s the first drug approved for patients with metastatic pancreatic cancer in nearly eight years, and analysts are expecting the combination of the albumin-bound version of paclitaxel and gemcitabine to become the new standard of care in what has remained an intractable disease. Read More
The FDA released briefing documents for Glaxosmithkline plc’s Anoro Ellipta (umeclidinium/vilanterol) inhaler product for chronic obstructive pulmonary disease (COPD) ahead of a scheduled advisory committee meeting on Sept. 10. The outlook for Anoro Ellipta appears to be smooth sailing, as the FDA’s clinical review found little to criticize in GSK’s submission. Read More
Five years after its launch, virtual biotech Aesrx LLC has advanced a small molecule anti-sickling agent into a Phase II trial in patients with sickle cell disease (SCD) – and done so without a venture capital round. If the compound proves its mettle, the company could become the first to market a treatment that directly blocks cell sickling rather than seeking simply to reduce the frequency of sickle cell crises. Read More
LONDON – Novabiotics Ltd. rejected a new round of private funding in favor of an exclusive licensing deal with Taro Pharmaceuticals North America Inc., for the co-development of its first-in-class antifungal peptide Novexatin, which is about to enter Phase IIb development in the treatment of nail infection onychomycosis. Read More
SHANGHAI – When it went public in April 2007, Simcere Pharmaceutical Group quickly became the largest Chinese pharmaceutical listed in the U.S. Despite a good early performance, the stock never lived up to its promise. The firm’s share price crashed to below $5 after the global financial crisis and has been lingering at below $10 since late 2011. Read More
Parkin is a well-known player in Parkinson’s disease – mutations in the protein, in fact, are the most common cause of familial Parkinson’s. The protein functions in mitochondrial quality control, tagging damaged mitochondria with ubiquitin for destruction by the autophagosome – a process that goes by the name mitophagy. Read More
• Cannabis Science Inc., of Colorado Springs, Colo., said the Depository Trust Company confirmed through official communication to the company that, effective immediately, it has lifted the share trading restriction “Chill” and has resumed accepting and processing deposits. Read More
• Cellular Biomedicine Group Inc., of Palo Alto, Calif., reported positive interim results of its Phase I/IIa trial for human adipose-derived mesenchymal precursor cell (haMPC) therapy for knee osteoarthritis. The study, which is testing the safety and efficacy of intra-articular injections of autologous haMPCs to reduce inflammation and repair damaged joint cartilage, showed preliminary findings of improvement (P Read More
• Baxter International Inc., of Deerfield, Ill., completed its acquisition of Gambro AB, of Lund, Sweden, for $3.9 billion. Baxter financed the transaction through cash from its overseas operations and debt issuances. Read More
• D&A Pharma, of Paris, will participate in the 14th Congress of the European Society for Biomedical Research on Alcoholism (ESBRA) in Warsaw Sept. 8-11, with results of trials of Alcover (sodium oxybate) showing that the drug met therapeutic objectives for management of alcohol dependence. Read More
A team from the University of Michigan has discovered that at least in the roundworm C. elegans, the neurons controlling muscles enter age-related decline before the muscles themselves do. One of the hallmarks of aging is that oldtimers, on the average, move less frequently and with less agility than youngsters – a change that puts the aged at risk of falls, among other things. One theory has been that this is due mainly to muscles not working as well as they did earlier in life. Read More
