We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Nabi Biopharmaceuticals has completed enrollment for its Phase IIB study of NicVAX (nicotine conjugate vaccine), the company's investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.
Avax Technologies has reached a Special Protocol Assessment (SPA) agreement with the FDA for the initiation of a Phase III clinical trial of M-Vax, the company's AC vaccine technology for the treatment of patients with metastatic melanoma.
Join FDAnews Tuesday, Oct. 31, for "Adaptive Clinical Trial Design: How to Lower Costs and Shorten Product Development Cycles." In this 90-minute interactive audioconference, Jerald S. Schindler, Dr.PH, president of Cytel Pharmaceutical Research Division, will explain how these trials can provide more information on a drug's efficacy, how they can result in a more ethical trial, how they can rescue a drug and how all this can be done without compromising the integrity of a trial. On Nov. 6, join FDAnews for "Proactive Planning for Recalls." In this 90-minute audioconference with Q&A session, noted attorney and author James M. Wood will share his proactive plan for product recalls -- developed from real-world lessons he's learned during 30 years representing prescription medicine and medical device manufacturers -- on matters ranging from product recalls to off-label and liability issues.
EpiCept announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Ceplene (histamine dihydrochloride), the company's lead oncology product candidate, administered in conjunction with interleukin-2 (IL-2), for the maintenance of first remission in patients with acute myeloid leukemia (AML).
GlaxoSmithKline (GSK) announced that it has submitted a supplemental new drug application (sNDA) to the FDA to expand labeling for Advair Diskus (fluticasone propionate/salmeterol inhalation powder) in the U.S. based on results from TORCH, a three-year study that showed a reduction in the risk of death and the rate of chronic obstructive pulmonary disease (COPD) exacerbations, and other supporting studies.
Ceregene has announced that CERE-120, a gene therapy product in development for the treatment of Parkinson's disease, was well-tolerated and appeared to reduce symptoms by approximately 40 percent, as measured by the Unified Parkinson's Disease Rating Scale motor "off" score, in an open-label Phase I study in 12 patients with advanced disease.
Inspire Pharmaceuticals announced that an investigational new drug application (IND) for epinastine nasal spray has been filed with the FDA and is in effect, having passed the 30-day review period.
Allergy Therapeutics announced that it achieved a positive outcome in a dose-ranging study of its Pollinex Quattro ragweed vaccine and has now successfully completed Phase II trials of this therapeutic vaccine.