Clostridium Difficile News and Research

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Clostridium difficile is a type of bacterium found in human and animal waste. Clostridium difficile is a common cause of diarrhea that occurs in hospitals. It can also cause diarrhea or other intestinal disorders in patients treated with antibiotics.

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

Viropharma 2010 third quarter net sales increases 46% to $317.4 million

ViroPharma Incorporated reported today its financial results for the third quarter ended September 30, 2010.

27 Oct 2010

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

ViroPharma Incorporated today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE).

25 Oct 2010

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Optimer Pharmaceuticals, Inc. announced today the presentation of combined data from its two fidaxomicin Phase 3 trials in patients with Clostridium difficile infection (CDI) at the 48th Annual Meeting of the Infectious Disease Society of America (IDSA) in Vancouver, British Columbia, Canada.

25 Oct 2010

FDA issues complete response letter for ViroPharma's Cinryze

ViroPharma Incorporated today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

25 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

ACG 75th Scientific Meeting to review advances in gastrointestinal research, treatment of digestive diseases

Many of the world's preeminent gastroenterologists will gather for the American College of Gastroenterology's (ACG) 75th Annual Scientific Meeting at the Henry B. Gonzalez Convention Center in San Antonio, Texas starting Monday October 18, 2010, to review the latest scientific advances in gastrointestinal research, treatment of digestive diseases and clinical practice management.

19 Oct 2010

Researchers explore impact of various factors on increasing rates of Clostridium difficile infection

In five different studies presented at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, researchers explored the impact of various factors on increasing rates of Clostridium difficile infection (C. difficile), such as the use of proton pump inhibitors (PPIs) and the substantial increase in antibiotic use due to new National Hospital Quality Measures; strategies to combat high rates of C. difficile infections; and cutting‐edge treatments for this potentially deadly-and quite common-infection.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Cubist third quarter total net revenues increase 13% to $162.1M

Cubist Pharmaceuticals, Inc. today announced results for the third quarter ended September 30, 2010.

15 Oct 2010

Progenics receives NIH grant to develop novel monoclonal antibodies to treat C. difficile infection

Progenics Pharmaceuticals, Inc. today announced the award of a grant totaling $4,143,652 from the National Institutes of Health (NIH) for Progenics' program to develop novel monoclonal antibodies to treat Clostridium difficile (C. difficile) infection.

7 Oct 2010

Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., today announced that it has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

1 Oct 2010

AJMS journal provides research update on new infectious pathogens

Newly recognized disease-causing viruses, bacteria, and other infections are continually emerging around the world, posing difficult challenges for patient diagnosis and treatment and for public health responses. A special symposium section of the September issue of The American Journal of the Medical Sciences (AJMS), official journal of the Southern Society for Clinical Investigation, provides a research update on important new infectious pathogens.

24 Sep 2010

Doctors misuse antibiotics to treat patients with respiratory tract infections: Study

Doctors frequently misuse antibiotics when treating patients hospitalized with respiratory tract infections (RTIs), according to a study to be published in the November issue of Infection Control and Hospital Epidemiology.

23 Sep 2010

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling 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. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Optimer Pharmaceuticals, Inc. announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.

15 Sep 2010

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Progenics Pharmaceuticals, Inc. today presented preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile.

14 Sep 2010

Death and disability toll due to C. diff bacteria needs to be addressed

Almost 12,000 people died in alcohol-related vehicle crashes in 2008. About 15,000 Americans died of AIDS-related illness the same year. Both of these preventable causes of death have been the subject of massive, expensive and high-profile interventions by federal and state authorities. CRE encourages expenditures for these programs but the public health community should be even more concerned for greater society-wide risks.

10 Sep 2010

Clostridium Difficile News and Research

Further Reading

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Viropharma 2010 third quarter net sales increases 46% to $317.4 million

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

FDA issues complete response letter for ViroPharma's Cinryze

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

ACG 75th Scientific Meeting to review advances in gastrointestinal research, treatment of digestive diseases

Researchers explore impact of various factors on increasing rates of Clostridium difficile infection

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Cubist third quarter total net revenues increase 13% to $162.1M

Progenics receives NIH grant to develop novel monoclonal antibodies to treat C. difficile infection

Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

AJMS journal provides research update on new infectious pathogens

Doctors misuse antibiotics to treat patients with respiratory tract infections: Study

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Death and disability toll due to C. diff bacteria needs to be addressed

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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