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ALLSCHWIL/BASEL, SWITZERLAND 27 February 2014 Actelion Ltd (SIX: ATLN) Guess Belt Black
The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in July 2012. The GAIN Act is Title VIII to FDASIA. The purpose of the GAIN Act is to encourage pharmaceutical research of certain antibiotics by designation of products as QIDPs. These products are intended to treat serious or life threatening infections and include those to treat certain specifically identified pathogens, which are listed in the GAIN Act. C. difficile is one such specifically identified pathogen and drugs to treat CDAD would be eligible for designation as a QIDP.
The results of the Phase II study indicate that the effect of all doses of cadazolid were numerically similar to, or better than vancomycin on key endpoints including CDAD clinical cure rates as well as sustained cure rates. Clinical cure rate was defined as the resolution of diarrhea and no further need for CDAD therapy at test of cure 24 to 72 hours after the last dose of treatment, while sustained cure rate was defined as clinical cure with no recurrence of CDAD up to 4 weeks post treatment. Recurrence rates were numerically lower for all doses of cadazolid as compared to vancomycin. Cadazolid was safe and well tolerated.
Actelion Ltd s Diarrhea Treatment Gets Fast Track From The FDA
Actelion's novel antibiotic cadazolid receives US FDA Qualified Infectious Disease Product designation for the treatment of Clostridium difficile associated diarrhea
The IMPACT studies are designed to determine whether the clinical response after administration of cadazolid is non inferior to vancomycin in subjects with CDAD, and whether administration of cadazolid is superior to vancomycin in the sustained clinical response. In preclinical studies cadazolid showed potent in vitro activity Hermes Belt Amazon
today announced that the US Food and Drug Administration (FDA) has designated cadazolid as both a Qualified Infectious Disease Product (QIDP) and a Fast Track development program for the treatment of Clostridium difficile associated diarrhea (CDAD).
IN THE PHASE II STUDY
Cadazolid absorption is negligible resulting in high gut lumen concentrations and low systemic exposure, even in severe cases of CDAD where the gut wall can be severely damaged and permeability to drugs potentially increased.
ABOUT THE IMPACT PROGRAM
designations are based on the 2012 US Generating Antibiotic Incentives Now (GAIN) Act. The GAIN act is a legislative effort to incentivize the development of new antibiotic agents that target serious life threatening infections. and Head of Clinical Development commented: "Clostridium difficile associated diarrhea is a very serious and potentially life threatening infection. There is a great need for an antibiotic that allows effective treatment of CDAD with low recurrence rates, particularly in infections caused by hypervirulent strains. The GAIN act highlights the importance of research in this area and we are very happy to receive the advantages that this designation for cadazolid will afford us."
IMPACT is an International Multi center Program Assessing Cadazolid Treatment in patients suffering from Clostridium difficile associated diarrhea (CDAD). The program comprises two Phase III studies comparing the efficacy and safety of cadazolid (250 mg administered orally twice daily for 10 days) versus vancomycin (125 mg administered orally four times daily for 10 days).
FDA document "Guidance for Industry on Fast Track Drug Development Programs: Designation, Development, and Application Review". This document is available on the Internet at:
ABOUT THE GAIN ACT (INCLUDING FAST TRACK DESIGNATION)
For further information regarding Fast Track Drug Development Programs, please refer to the
Cadazolid was studied in a Phase II multi center, double blind, randomized, active reference, parallel group, therapeutic exploratory study. As the current standard of care for CDAD, oral vancomycin (125 mg qid for 10 days) was used as the active reference. The study was completed in December of 2012, after having enrolled 84 subjects with CDAD.
against Clostridium difficile clinical isolates and a low propensity for resistance development. In a human gut model of CDAD, cadazolid had a very limited impact on the normal gut microflora.
Clostridium difficile is a Gram positive, anaerobic, spore forming bacterium that is the leading cause of nosocomial diarrhea. Clostridium difficile associated diarrhea (CDAD or CDI for Clostridium difficile infection) can be a severe and life threatening disease and results from the overgrowth in the colon of toxigenic strains of Clostridium difficile, generally during or after therapy with broad spectrum antibiotics. CDAD is a major healthcare problem and a leading cause of morbidity in elderly hospitalized patients. The frequency and severity of CDAD in the western world has increased in recent years, and new hypervirulent and epidemic strains of Clostridium difficile have been discovered that are characterized by overproduction of toxins and other virulence factors, and by acquired resistance to fluoroquinolones such as moxifloxacin.
2. Louie TJ, et al. Abstract/poster LB 2956, 53rd European Congress of Clinical Microbiology and Infectious Diseases.
The GAIN Act also provides that qualifying drugs (QIDPs) are eligible for inclusion in the FDA's Fast Track program. This program is intended to facilitate development and expedite review of new drugs and includes close early communication between the FDA and a drug's sponsor.
Only one new antibiotic, fidaxomicin, has been approved over the last 30 years for this indication, and there remains a need for new drugs with improved properties, in particular, antibiotics that allow effective treatment of infections caused by hypervirulent strains, with low recurrence rates.1. Baldoni D, et al. J. Antimicrob. Chemother. Published online ahead of print.
3. Gerding DN, et al. Abstract/poster K 168, 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy.
ABOUT FAST TRACK DRUG DEVELOPMENT PROGRAMS
Current antibiotic therapy for CDAD includes vancomycin and metronidazole. While clinical cure rates are generally 85 Gucci Belt Square Buckle 90%, recurrences rates of 15 30 % with either drug are problematic as Clostridium difficile produces spores that are resistant to antibiotic treatment and routine disinfection. Spores surviving in the gut of patients and/or in the hospital environment may play a major role in re infection and recurrence of CDAD after antibiotic treatment. Vancomycin and metronidazole are reported to promote spore formation in vitro at sub inhibitory concentrations.
The QIDP designation for cadazolid means that among other incentives cadazolid would receive a nine month priority review upon successful completion of the ongoing global Phase III IMPACT program. The Fast Track designation is intended to promote communication and collaboration between the FDA and the Company on the development of the drug.
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