Content about Digestive diseases

July 17, 2012

A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

Janssen Biotech and Janssen Biologics B.V. announced the submission of a supplemental regulatory application to the Food and Drug Administration for Simponi (golimumab) for treatment of moderately to severely active ulcerative colitis, an inflammatory bowel disease that affects about 700,000 people in the United States. The drug already is approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

June 26, 2012

An organization focused on Crohn's disease and ulcerative colitis has revamped its website, the group said Tuesday.

NEW YORK — An organization focused on Crohn's disease and ulcerative colitis has revamped its website, the group said Tuesday.

The Crohn's and Colitis Foundation of America said it worked with Pittsburgh-based digital marketing agency BarkleyREI to redesign the website. The new site includes a section for people newly diagnosed with the diseases; a library that includes webcasts, brochures, fact sheets and videos; social media integration; pages listing local chapters and support groups; and other resources.

May 24, 2012

Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.

May 10, 2012

Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

April 23, 2012

Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

Handa, based in Fremont, Calif., sold rights to the regulatory approval application it filed with the Food and Drug Administration for dexlansoprazole capsules, a generic version of Takeda's Dexilant, in the 60-mg strength.

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.

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 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.

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.

May 26, 2011

A health education television network has added nine condition-specific networks.

NEW YORK — A health education television network has added nine condition-specific networks.

AccentHealth said in addition to its current lineup of four networks, the company will focus its attention on diabetes, heart health, men's health, mental health, senior women's health, rheumatology, allergies, asthma and gastroesophageal reflux disease. These networks will reach and educate more than 13 million patients in doctors' waiting rooms each month through its digitally delivered content, the company said.

April 5, 2011

Studies have indicated that proton-pump inhibitors, used for treating gastroesophageal reflux disease, reduce the efficacy of a popular blood-thinning drug, but Takeda Pharmaceuticals North America announced on Tuesday the results of a new study indicating that its own PPIs may have less of an effect.

NEW ORLEANS — Studies have indicated that proton-pump inhibitors, used for treating gastroesophageal reflux disease, reduce the efficacy of a popular blood-thinning drug, but Takeda Pharmaceuticals North America announced on Tuesday the results of a new study indicating that its own PPIs may have less of an effect.

March 23, 2011

Most patients that suffer from gastroesophageal reflux disease or persistent heartburn symptoms rarely speak with a healthcare provider about their condition, according to a new study conducted on behalf of the American Gastroenterological Association, in partnership with drug maker Takeda.

BETHESDA, Md. — Most patients that suffer from gastroesophageal reflux disease or persistent heartburn symptoms rarely speak with a healthcare provider about their condition, according to a new study conducted on behalf of the American Gastroenterological Association, in partnership with drug maker Takeda.

March 2, 2011

The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.

October 4, 2010

The drug market for ulcerative colitis treatments will see modest growth through 2019, according to...

BURLINGTON, Mass. The drug market for ulcerative colitis treatments will see modest growth through 2019, according to a new report by Decision Resources.

The research and advisory firm said that the UC drug market will see growth of $800 million, driven by the uptake of Abbott and Eisai's Humira, Centocor Ortho Biotech/Merck/Mitsubishi Tanabe Pharma/Janssen's Simponi and Millennium's vedolizumab in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

July 5, 2010

The Food and Drug Administration has approved a gastroesophageal reflux disease drug made by Lupin...

January 10, 2010

GlaxoSmithKline has obtained an exclusive license to develop and commercialize an investigational treatment for such...

January 3, 2010

A new report by Decision Resources revealed that a biological therapy with a mechanism of...

January 3, 2010

New research indicates that the activation of an inflammatory mediator in the human body may...