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Crucell has announced the completion of its Phase I safety study with the alum-adjuvanted formulation of its whole-inactivated West Nile vaccine manufactured using PER.C6 technology.
Altea Therapeutics has announced positive results from Phase I human clinical studies of its basal insulin transdermal patch showing efficient, sustained and constant delivery of insulin at therapeutic levels.
Lexicon Genetics has initiated Phase I clinical trials of LX1031,its oral drug candidate for irritable bowel syndrome (IBS) and other gastrointestinal disorders.
BioCryst Pharmaceuticals has initiated a Phase II clinical trial of peramivir, the company's lead influenza neuraminidase inhibitor, to determine the safety and efficacy of an intramuscular formulation of the drug in patients with influenza.
Obecure has begun its first Phase II clinical trial to evaluate the efficacy of the company's OBE101 (betahistine) drug candidate for weight loss in obese patients.
Bayer HealthCare has decided to end three ongoing Phase III studies investigating the safety and efficacy of Trasylol (aprotinin injection) on transfusion requirements and blood loss in adults undergoing elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.
Join FDAnews Thursday, Feb. 1, for "Clinical Trial Billing Under Medicare: How the New National Coverage Decision Will Impact You." In this special 105-minute interactive audioconference, noted attorney Mark Barnes will provide the information you need to receive reimbursement from the Centers for Medicare & Medicaid Services for clinical trial expenses without running afoul of the Office of Inspector General. On Feb. 6, join FDAnews for "Clinical Trial Site Selection: Strategies to Gain a Competitive Advantage." In this 90-minute audioconference with Q&A session, Christine Pierre, president and CEO of RxTrials, will share proven methods and behind-the-scenes secrets of site selection you can use to ensure the sites you choose meet your needs.