LONDON – Newron Pharmaceuticals SpA has found a new partner for its Phase III drug safinamide, securing a €20 million (US$26.1 million) opening payment, with milestones and royalties to come, from the Italian pharma company Zambon SpA. Read More
WASINGTON – Despite warnings against weighing down the PDUFA and other user fee agreements negotiated between the FDA and industry, Congress is piling on the calories with favorite menu items ranging from drug shortage notification to social media guidance. Read More
Privately held OvaScience has burst onto the infertility scene in a big way, raising $43 million since its founding in 2011, including a $37 million Series B round that closed this week. Read More
• Zalicus Inc., of Cambridge, Mass., published preclinical data in Molecular Cancer Therapeutics showing that adenosine A2A and beta-2 adrenergic receptor agonists enhance glucocorticoid activity in B-cell malignancies like multiple myeloma. Read More
• Molecular Partners AG, of Schlieren, Switzerland, said partner Allergan Inc., of Irvine, Calif., recently reported that AGN-150998/MP0112, an anti-VEGF DARPin compound, was shown to be safe and well tolerated, with no dose-limiting toxicity, after a single administration in Phase IIa trial in macular edema. Preliminary efficacy results suggested a dosing interval of up to three months. Read More
• Nile Therapeutics Inc., of San Mateo, Calif., closed its previously announced registered direct offering, raising $1.34 million. The company sold 3.35 million shares of common stock and warrants to purchase an additional 2.5 million shares. Proceeds will help to fund a Phase II trial of cenderitide for heart failure. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA decided the firm is sole first-to-file for both Orange Book patents listed for wakefulness drug Provigil (modafinil) and, therefore, Teva's abbreviated new drug application alone is entitled to 180-day exclusivity. Read More
