Gastrointestinal Infections

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FDA delays approval decision for Merck’s bezlotoxumab

July 22, 2016

Read the Perspective from Colleen R. Kelly, MD

The FDA has extended the Prescription Drug User Fee Act goal date for Merck’s investigational biologic for the prevention of recurrent Clostridium difficile infection, bezlotoxumab, by 3 months, according to a press release from the manufacturer.

The new PDUFA goal date is October 23. The company’s Biologics Licensing Application previously received priority review designation from the FDA, with an original PDUFA goal date of July 23.

Potential norovirus outbreak sickens GOP national convention staffers

July 19, 2016
The Erie County Health Department in Ohio has reported at least 12 illnesses consistent with norovirus infection among staffers attending the Republican National…
In the Journals

Disproportionate burden of HIV, hepatitis, TB among prisoners driven by IDUs, insufficient care

July 14, 2016
Although prisoners and detainees constitute a substantial proportion of the global HIV, hepatitis and tuberculosis burdens, many incarcerated persons do not receive…
In the Journals

Feeding at breast may reduce risk for otitis media, diarrhea among infants

July 12, 2016
Breast-feeding could significantly reduce the risk for diarrhea and feeding at the breast instead of from a bottle or formula may reduce otitis media infections in…
CME

Evolution of HIV Treatment: How to Start, How to Switch, How to Treat HIV/HCV Co-infection

This activity is supported by an educational grant from Gilead Sciences Medical Affairs.

Improvements in antiretroviral therapy (ART) continue to be made with the development of simplified, single-tablet…
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GI Bookshelf

Chapter 14: Nutrition In The Elderly

From Clinical Nutrition in Gastrointestinal Disease
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Zika Resource Center

Zika Resource Center

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VIDEO: Expert discusses H. pylori-associated gastric cancer mechanisms, research

January 22, 2016
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FDA News

FDA delays approval decision for Merck’s bezlotoxumab

July 22, 2016
The FDA has extended the Prescription Drug User Fee Act goal date for Merck’s investigational biologic for the prevention of recurrent…

Potential norovirus outbreak sickens GOP national convention staffers

July 19, 2016
The Erie County Health Department in Ohio has reported at least 12 illnesses consistent with norovirus infection among staffers attending the…

In the Journals

Disproportionate burden of HIV, hepatitis, TB among prisoners driven by IDUs, insufficient care

July 14, 2016
Although prisoners and detainees constitute a substantial proportion of the global HIV, hepatitis and tuberculosis burdens, many incarcerated persons…

In the Journals

Feeding at breast may reduce risk for otitis media, diarrhea among infants

July 12, 2016
Breast-feeding could significantly reduce the risk for diarrhea and feeding at the breast instead of from a bottle or formula may reduce otitis media…

Hawaii, South Dakota report cases of HAV

July 12, 2016
The Hawaii Department of Health recently announced that 31 cases of hepatitis A virus infection have been reported on Oahu that may be linked to food…

In the Journals

In-house assay effective for monitoring HBV in resource-limited countries

July 11, 2016
Researchers in France developed an in-house assay that was accurate, simpler and cheaper for detecting hepatitis B virus infection plasma than…

Seres initiates first clinical trial of synthetic microbiome therapy for C. difficile

July 8, 2016
Seres Therapeutics has initiated a phase 1b clinical trial of SER-262 in patients with primary Clostridium difficile infection. This is the first…

In the Journals

Mortality from viral hepatitis increases as other ID-related deaths decrease

July 6, 2016
Viral hepatitis-related mortality increased by 63% over a 23-year period, whereas mortality from other infectious diseases, such as HIV, tuberculosis…

In the Journals

EndoFaster enables real-time H. pylori diagnosis during endoscopy

July 6, 2016
EndoFaster, a novel device that performs automatic, real-time measurement of ammonium in gastric juice, accurately detected Helicobacter pylori

First patients dosed in ContraVir study comparing CMX157 and Viread

July 5, 2016
ContraVir Pharmaceuticals Inc. has announced dosage of the first patients with chronic hepatitis B in its phase 2a study comparing ContraVir’s…

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