With $38 million in Series B money, Civitas Therapeutics Inc.’s can finish its ongoing, 80-patient Phase IIb trial testing inhaled levodopa (L-dopa) in Parkinson’s disease patients, and get ready for a Phase III trial that would begin in the second half of next year. Read More
SHANGHAI – A joint venture between a Chinese and a Swiss company has launched Phase III trials for a botanical drug to treat inflammatory bowel disease. Read More
Prometic Life Sciences Inc., of Laval, Quebec, will earmark a portion of the proceeds from a $10 million financing from Thomvest Seed Capital Inc. to commission its GMP facility for manufacture of plasma-derived orphan drugs. Read More
After a decade of work, French vaccine developer Imaxio SA achieved a significant milestone when IMX313, its pro-immunogenic technology, was administered for the first time in humans in a Phase I tuberculosis (TB) vaccine trial. Read More
Since their initial description in 2007, induced pluripotent stem (iPS) cells have been investigated as a possible alternative to embryonic stem cells. By adding a cocktail of so-called reprogramming factors, scientists can turn mature cells – most often skin cells – into pluripotent cells that can turn into many different cell types. Read More
• Hedgepath Pharmaceuticals Inc., (HPPI) of Tampa, Fla., said it signed an exclusive supply and license deal with Mayne Pharma International Pty. Ltd., a subsidiary of Melbourne, Australia-based Mayne Pharma Group Ltd., whereby HPPI will pursue clinical development of Mayne’s formulation of itraconazole, known as Suba-Itraconazole, for the treatment of a variety of cancers, with a focus on seeking regulatory approvals and marketing in the U.S. Read More
• Ovascience Inc., of Cambridge, Mass., suspended enrollment of a trial with Augment, its candidate designed to improve egg quality and increase the success of in vitro fertilization, because the FDA questioned the status of the product as a human cellular tissue-based product and wants the firm to file an investigational new drug application. Read More
• A new analysis from the Tufts Center for the Study of Drug Development (CSDD) showed that while lack of commercial viability is the leading cause of Phase I failures for new drug candidates, efficacy issues lead as the reason behind Phase II failures. Read More
• Chimerix Inc., of Durham, N.C., disclosed results from its exploratory Phase II Study 202 evaluating brincidofovir (CMX001) in hematopoietic cell transplant (HCT) recipients with early adenovirus (AdV) infection. Read More
• Merck and Co. Inc., of Whitehouse Station, N.J., licensed its oral small-molecule inhibitor of WEE1 kinase (MK-1775) to Astrazeneca plc, of London. Read More