Optimer Pharmaceuticals, Inc.announced that it has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. It is the most common cause of diarrhea in the hospital, and according to the CDC contributes to 15,000-30,000 deaths each year, a number that surpasses Methicillin-resistant Staphylococcus aureus (MRSA).
New data demonstrated that antibodies induced by Novartis Vaccines investigational, four component, Meningococcal Serogroup B Vaccine (4CMenB) killed the majority of a collection of geographically and genetically diverse meningococcal serogroup B (MenB) strains. The strain coverage research findings were recently published in the Proceedings of the National Academy of Sciences.
Helix BioPharma Corp. announced that it has completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with L-DOS47. These studies demonstrated a good safety profile in an expanded number of rodent and primate test animals, building upon Helix’s positive findings from its preliminary non-GLP toxicology studies.
Cumberland Pharmaceuticals Inc. announced the publication of data affirming the safety and efficacy of Caldolor(R) (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.
Amgen announced that it has won the Best New Drug awardfor Prolia(TM) (denosumab), a novel treatment approved in the United States (U.S.) for women with postmenopausal osteoporosis at high risk for fracture, at the2010 Scrip Awards ceremony Nov. 4 in London. Named one of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is the first treatment specifically designed to target osteoclasts, the cells that break down bone.
B. Braun, In an effort to meet industry demands for expanded Cephalosporin offerings delivered to patients through safe and accurate administration, B. Braun Medical Inc. (B. Braun) announced that FDA-approved 1g and 2g Cefepime for Injection USP and Dextrose Injection USP in B. Braun Medical Inc.’s DUPLEX® Drug Delivery System will be available for purchase beginning today.
Scientists from The Scripps Research Institute have uncovered new evidence that challenges the current theory about a process key to the way modern drugs are designed and how they work in the human body.