WASHINGTON – In vacating a preliminary injunction that protected Momenta Pharmaceuticals Inc.'s $1 billion a year monopoly on generic Lovenox, the Federal Circuit gave the makers of generic drugs a much wider safe harbor under Hatch-Waxman. Read More
K-V Pharmaceutical Co. filed for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court for the Southern District of New York, in order to restructure its financial obligations, principally a milestone payment to Bedford, Mass.-based Hologic Inc. Read More
To help fuel its clinical trials programs on lead product candidate, cabozantinib, Exelixis Inc. (NASDAQ:EXEL) said it is planning an underwritten debt offering of $225 million convertible senior subordinated notes due 2019 and a concurrent sale of 20 million shares of its common stock. Read More
Fewer than five years after Adynxx Inc. was formed on the basis of "a great idea," the company disclosed that it moved lead compound AYX1 into the clinic, completing enrollment in a Phase I safety study in postoperative pain. Read More
• Astellas Pharma Inc., of Tokyo, disclosed plans to close subsidiary Urogenix Inc., of Durham, N.C., a research facility focused on urology drug discovery that was acquired in 2006 from Dynogen Pharmaceuticals Inc. Read More
• Oxigene Inc., of Waltham, Mass., passed an interim toxicity analysis in its Phase II trial of Zybrestat (fosbretabulin tromethamine) and bevacizumab for ovarian cancer. Patients were randomized to receive bevacizumab 15 mg/kg I.V. or bevacizumab plus fosbretabulin tromethamine 60 mg/m2 I.V. Read More
• Curemark LLC, of Rye, N.Y., received FDA clearance for enrollment of children ages 9-12 into its open-label extension study of CM-AT for children with autism. Read More
• Discovery Labs Inc., of Warrington, Pa., was issued U.S. Patent No. 8,221,772, "Pulmonary Surfactant Formulations and Methods for Promoting Mucus Clearance." The patent covers a method to promote mucus clearance in those with pulmonary conditions that lead to excess mucus secretion or impaired mucus clearance present in diseases such as cystic fibrosis and chronic obstructive pulmonary disease. Read More
