This year's FDA approval of Horizant (gabapentin enacarbil) for restless legs syndrome came with a twist: XenoPort Inc. and partner GlaxoSmithKline plc originally developed and submitted the drug for approval via the "traditional" 505(B)(1) pathway; only after receiving a complete response letter did the firms shift their strategy, refile via the 505(B)(2) pathway, and gain approval. Read More
WASHINGTON – Whether it's funding the "doc fix" or finding potential savings, Medicare's Part D prescription drug program is a popular fix-it target these days. Read More
A study published last week showed how the eye protects itself from inflammatory damage – and how, when this process doesn't work well, disease can result. Read More
ApoLife Inc. has joined the growing ranks of platform technology companies branching out into internal drug discovery and development. At a time when other small biotech companies are struggling to secure start-up financing, ApoLife already has a revenue stream from its yeast-based antibody production business. Read More
Cel-Sci Corp., of Vienna, Va., closed its registered direct offering of 13.3 million shares priced at 30 cents apiece and warrants to purchase up to 12 million shares at 40 cents apiece, and estimated net proceeds to be about $3.85 million. Read More
Adherex Technologies Inc., of Research Triangle Park, said the FDA's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee will discuss the development of sodium thiosulfate injection, USP, 20 percent (STS) Nov. 1. Read More
Dynavax Technologies Corp., of Berkeley, Calif., said results of a prospective analysis of the diabetic subset population from its Phase III trial (HBV-16) showed the superiority of Heplisav vs. Engerix-B (GlaxoSmithKline plc) at all measured time points. Read More
Researchers from Stanford University have worked out a regimen that allows kidney transplant patients to go off immunosuppressant drugs – a step that enables them to lead fuller lives whiles saving tens of thousands of dollars in immunosuppressant drug costs annually. Read More
