Aiming to cover the landscape of hyperoxaluria – overproduction of oxalate in the kidneys, which can lead not only to painful stones but also, in other forms, complications as serious as end-stage renal disease – Allena Pharmaceuticals Inc. raised $25 million in a series B financing. Read More
BOGOTA, Colombia – Latin American subregional bloc Mercosur, which includes Argentina, Brasil, Paraguay, Uruguay and Venezuela, will stop buying human papillomavirus (HPV) vaccines through the Pan American Health Organization (PAHO). Read More
Array Biopharma Inc. shares (NASDAQ:ARRY) climbed 14.3 percent to $4.47 Thursday as Novartis AG returned full rights to the phase III MEK inhibitor, binimetinib, pledging up to $85 million plus significant follow-on support for Array’s plans to seek approval for using the drug to treat NRAS-mutant melanoma during the first half of 2016. Read More
SHANGHAI – Over the last few years, multinational corporations (MNCs) have become increasingly comfortable with adding China sites to their lists of multiregional clinical trials (MRCTs). A significant reason for doing so has been the possibility of conducting trials simultaneously, potentially shaving years off the regulatory time frame for imported drug approvals in China. Read More
LONDON – Gene therapy for babies born with a rare, but severe type of inherited heart disease could become a realistic option in the future, scientists suggest, following successful prevention of disease in a related mouse model Read More
ANI Pharmaceuticals Inc., of Baudette, Minn., said it is offering $100 million aggregate principal amount of convertible senior notes in an underwritten public offering. Read More
Codexis Inc., of Redwood City, Calif., said it has developed a new enzyme therapeutic candidate for the potential treatment of phenylketonuria (PKU) via oral administration. Read More
Oncosec Medical Inc., of San Diego, released long-term survival results from its phase I study in patients with metastatic melanoma, evaluating a single treatment cycle of intratumoral plasmid IL-12 (pIL-12) injection with electroporation (EP). Read More
Bayer AG, of Leverkusen, Germany, said data from its study of children (infants) younger than 2 years of age were presented at the 2014 Radiological Society of North America Scientific Assembly and Annual Meeting. The primary endpoint of the study was the evaluation of the pharmacokinetics (PK) of Gadavist (gadobutrol) injection in plasma at the standard dose of 0.1 mmol/kg body weight. Read More
Teva Pharmaceutical Industries Ltd., of Jerusalem, received a positive outcome in the decentralized procedure for its new, three-times-a-week Copaxone (glatiramer acetate) 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis. Read More
