Concert Pharmaceuticals Inc.'s third deal in just over two years with its deuterium-modifying platform brought Celgene Corp. aboard for a single project at first – an up-front payment along with more than $300 million possible in milestone rewards – but with the potential for more compounds that would bring similar financial terms. Read More
In the wake of promising preclinical data for its hepatitis B virus (HBV) candidate, Arrowhead Research Corp. shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection. Read More
After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class. Read More
Armed with a novel technology and a new target – a class of disease modifying therapies that preserve intracellular S-nitrosoglutathione (GSNO), a regulator of organ repair, regeneration and healing – N30 Pharmaceuticals Inc. has quietly evolved from a 2007 start-up into a development-stage biotech with 30 employees. Read More
• Kala Pharmaceuticals Inc., of Waltham, Mass., presented preclinical data suggesting that topical delivery of a small-molecule receptor tyrosine kinase inhibitor (RTKi) formulated using its mucosal-penetrating particle (MPP) technology enhanced drug levels in the retina. Read More
• Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S. for the investigational oral Bruton's Tyrosine Kinase inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics Inc., of Sunnyvale, Calif. Read More
• CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion. Read More
