Content about Gastroenterology

February 9, 2012

The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

January 31, 2012

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

January 6, 2012

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

SAN DIEGO — Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

The application was for Uceris (budesonide) tablets in the 9-mg strength for moderate active UC. The company is developing the drug under a collaboration with Cosmo Technologies.

 


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December 20, 2011

The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

December 5, 2011

The holidays stand as prime time heartburn season with Thanksgiving dinners and holiday get-togethers on the calendar. And that doesn’t even cover the obligatory holiday fruitcakes.


The holidays stand as prime time heartburn season with Thanksgiving dinners and holiday get-togethers on the calendar. And that doesn’t even cover the obligatory holiday fruitcakes.


December 2, 2011

Axia3 on Thursday announced the launch of its Axia3 ProDigestive antacid as a new dietary supplement that delivers relief from occasional heartburn, with a proprietary blend of potent ProDigestive enzymes to help promote healthy digestion.

LOS ANGELES — Axia3 on Thursday announced the launch of its Axia3 ProDigestive antacid as a new dietary supplement that delivers relief from occasional heartburn, with a proprietary blend of potent ProDigestive enzymes to help promote healthy digestion.

"Heartburn and other digestive discomforts such as indigestion, sour stomach and bloating afflict millions of people each year," Axia3 CEO Ryan Doheny said. "In fact, more than 100 million people in the U.S. each year suffer from heartburn."

November 9, 2011

Retailers are gearing up for the holiday seasons, and have every intent of coaxing their shoppers into filling a shopping cart, such as this one at a central Pennsylvania Rite Aid.

October 31, 2011

Sam's Club is offering a free digestive health screening this month.

BENTONVILLE, Ark. — Sam's Club is offering a free digestive health screening this month.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.

October 19, 2011

Many of this country's 80 million baby boomers who take medications for such conditions as pain, high cholesterol, hypertension and even depression are not aware that some of those medications could lead them to seek relief from occasional constipation.

STAMFORD, Conn. — Many of this country's 80 million baby boomers who take medications for such conditions as pain, high cholesterol, hypertension and even depression are not aware that some of those medications could lead them to seek relief from occasional constipation, according to a nationwide survey of 1,150 men and women age 50 years or older taking medications for common medical conditions released by Purdue Products Wednesday.

October 11, 2011

Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

NEW YORK — Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

September 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

HORSHAM, Pa. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

J&J subsidiary Janssen Biotech said Friday that the FDA approved Remicade (infliximab) for moderately to severely active ulcerative colitis in children who have not responded adequately to conventional therapies.

September 21, 2011

Researchers at the University of California Los Angeles said they have found a possible link between two new drugs for Type 2 diabetes and cancers of the pancreas and thyroid, according to a new study published in the journal Gastroenterology.

LOS ANGELES — Researchers at the University of California Los Angeles said they have found a possible link between two new drugs for Type 2 diabetes and cancers of the pancreas and thyroid, according to a new study published in the journal Gastroenterology.

The researchers, at UCLA's Larry L. Hillblom Islet Research Center, examined incidents reported in the Food and Drug Administration's adverse event database between 2004 and 2009 among patients using Byetta (exenatide), made by Eli Lilly and Amylin Pharmaceuticals, and Merck's Januvia (sitagliptin).

September 1, 2011

Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

HAMILTON, Ontario — Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

In a study published in the medical journal Gastroenterology, principal investigator John Wallace reported the extent of the hard-to-detect damage caused to the small intestine only recently has been discovered through use of small video cameras swallowed like pills.

August 26, 2011

The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

The FDA announced the approval of Firazyr (icatibant) for acute attacks of hereditary angioedema in patients ages 18 years and older. HAE, which affects fewer than 30,000 people in the United States, results from improper function of C1 inhibitor, a protein that regulates how certain immune system and blood clotting pathways function.

July 28, 2011

The Hepatitis Education Awareness and Liver Support of the South is advocating for awareness about hepatitis and the importance of Medicare Part D as part of World Hepatitis Day, the organization said Thursday.

TALLAHASSEE, Fla. — The Hepatitis Education Awareness and Liver Support of the South is advocating for awareness about hepatitis and the importance of Medicare Part D as part of World Hepatitis Day, the organization said Thursday.

July 22, 2011

A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

July 18, 2011

The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.

The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.

July 12, 2011

The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

PLANEGG-MARTINSRIED, Germany — The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

4SC announced that it received the designation for resminostat, currently in phase-2 clinical trials as a treatment for hepatocellular cancer, or HCC. The FDA grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States.

July 6, 2011

Pharmacy benefit manager Medco Health Solutions’ specialty pharmacy division, Accredo Health Group, has managed to drive down costs for treating hepatitis C by an average of $13,000 per patient, the company said Tuesday.

FRANKLIN LAKES, N.J. — Pharmacy benefit manager Medco Health Solutions’ specialty pharmacy division, Accredo Health Group, has managed to drive down costs for treating hepatitis C by an average of $13,000 per patient, the company said Tuesday.

Medco said Accredo had been successful in using genotype information to identify patients who only may need 24 weeks of therapy, as opposed to 48 weeks, thus reducing costs.

June 20, 2011

A new study recently estimated that 5.9 million children in the United States suffer from a food allergy.

NEW YORK — A new study recently estimated that 5.9 million children in the United States suffer from a food allergy.

The study, published in the July issue of Pediatrics, also found that children with a tree nut or peanut allergy tend to have the most severe reactions, with nearly 39% of children ages 18 years and younger surveyed saying they had a severe or life-threatening allergy. Additionally, more than 30% of children surveyed said they suffered from multiple food allergies.

The study was funded by the Food Allergy Initiative.

June 20, 2011


Good things come in three — like the three antacids that for the 52 weeks ended April 17 collectively generated more than $118 million in sales on top of the sales base they had established in the year-ago period.



Good things come in three — like the three antacids that for the 52 weeks ended April 17 collectively generated more than $118 million in sales on top of the sales base they had established in the year-ago period.


June 14, 2011

The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

June 3, 2011

CVS Caremark is enhancing its hepatitis C patient support program following the recent Food and Drug Administration approval of two new add-on therapies for hepatitis C, the company announced on Friday.

WOONSOCKET, R.I. — CVS Caremark is enhancing its hepatitis C patient support program following the recent Food and Drug Administration approval of two new add-on therapies for hepatitis C, the company announced on Friday.