Poised to wade into a crowded field of drugs for hereditary angioedema (HAE), Santarus Inc. and partner Pharming Group NV said the pivotal Phase III study with the C1 esterase inhibitor Ruconest for acute HAE attacks met the primary endpoint of time to beginning of symptom relief. Read More
Enanta Pharmaceuticals Inc., of Watertown, Mass., filed with the SEC an S-1 for an initial public offering (IPO) worth $69 million to support its work in the area of hepatitis C virus (HCV). Read More
Poxel SA's lead oral diabetes drug, imeglimin, reached the primary endpoint in a Phase II trial in Type II diabetes patients, demonstrating statistically significant decreases in plasma glucose and fasting plasma glucose levels when administered in combination with sitagliptin vs. treatment with sitagliptin alone. Read More
• BiondVax Pharmaceuticals Ltd., of Nes Ziona, Israel, entered a partnership with Warren, N.J.-based MonoSol Rx LLC to develop an oral film formulation of BiondVax's universal flu vaccine, M-001, using MonoSol Rx's PharmFilm delivery platform. The collaboration will include studies using PharmFilm technology to investigate the activity and formulation of the influenza vaccine when delivered via an oral film. Financial terms were not disclosed. Read More
• Moberg Derma AB, of Stockholm, Sweden, said it received the final results from a Phase II study of MOB-015 in patients with onychomycosis and, because the clinical efficacy was unsatisfactory, said it decided to initiate a new study with an improved formulation. The new trial, set to enroll 35 patients, will start in December. Read More
• Sosei Group Corp., of Tokyo, and Novartis AG, of Basel, Switzerland, said an application has been submitted for the registration of QVA149, an investigational fixed-dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide), as a once-daily treatment for chronic obstructive pulmonary disease in Japan. Read More
• Vivus Inc., of Mountain View, Calif., reported net product revenues of $41,000 from prescriptions of newly approved obesity drug Qsymia (phentermine/topiramate) shipped from certified pharmacies to patients. The drug, approved in July, was made available starting Sept. 17. Read More
