Gastroenterology News and Research

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Gastroenterology is the branch of medicine where the digestive system and its disorders are studied.

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

Clinical study investigates laboratory and clinical implications of proton pump inhibitor drugs

Fears about the cancer causing effects of the second most prescribed group of drugs in the Western world have been put to rest, following the largest ever study into their use.

10 Sep 2009

Caldolor launched ahead of schedule in U.S. by Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has successfully implemented the U.S. launch of Caldolor((R)), an intravenous formulation of ibuprofen, designed primarily for use in the hospital setting.

9 Sep 2009

A voluntary recall program announced by CONMED Linvatec

CONMED Corporation's (NASDAQ: CNMD) CONMED Linvatec unit announced today a voluntary recall for certain model numbers of the PRO5 & PRO6 series battery handpieces manufactured prior to May 31, 2008, and certain lots of the MC5057 Universal Cable manufactured prior to December 1, 2006 used with certain of CONMED Linvatec's electric powered handpieces.

9 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

First results of European survey of cancer patients' experience of breakthrough pain presented at EFIC

The first results of the first European survey of cancer patients' experience of breakthrough pain were presented today at the 6th congress of the European Federation of Chapters of the International Association for the Study of Pain (EFIC).

9 Sep 2009

Study to test efficacy of lapatinib in advanced hepatocellular carcinoma

Use of the molecularly targeted agent lapatinib to delay tumor growth and improve the survival of patients with inoperable hepatocellular carcinoma, or liver cancer, only benefited certain subgroups of patients. While results of this study were largely negative, patients that exhibited toxicity from the drug in the form of a skin rash appeared to have a greater tumor response and longer survival.

9 Sep 2009

Regurin XL capsule for the treatment of OAB launched in UK

Regurin(R) XL (trospium chloride), a once-daily, prolonged-release capsule to treat patients with overactive bladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid, significant and consistent improvements in the symptoms of OAB1 and has a reduced potential for central nervous system (CNS) side effects(2-7).

7 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

Less-invasive, organ-sparing endoscopic therapy for treating early stages of esophageal cancer

Researchers have found that early stage cancers of the esophagus can be treated as effectively by less-invasive, organ-sparing endoscopic therapy as compared to more complex surgical removal of the esophagus, according to a Mayo Clinic study published in the September 2009 issue of Gastroenterology.

2 Sep 2009

NASDAQ Stock Market issues noncompliance letter to Encorium Group

Encorium Group, Inc. (Nasdaq: ENCO), a full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced that on August 25, 2009, it received a letter from The NASDAQ Stock Market notifying the Company that, based on its Form 10-Q for the period ended June 30, 2009, NASDAQ has determined that the Company's stockholders' equity does not comply with the minimum $2.5 million stockholders' equity requirement for continued listing on The NASDAQ Capital Market as required by NASDAQ Marketplace Rule 5550(b)(1).

1 Sep 2009

Cumberland Pharmaceuticals to discuss its recently approved FDA product at the UBS Conference

Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that Chief Executive Officer A.J. Kazimi will present at the UBS Global Life Sciences Conference in New York at 11:00 a.m. Eastern Time on Monday, September 21, 2009. Mr. Kazimi will provide an update on the Company and its Caldolor product, which Cumberland is preparing to launch following its recent approval by the Food and Drug Administration.

1 Sep 2009

Nighttime acid reflux symptoms impair sleep quality

There has been much debate about the relationship between gastroesophageal reflux disease (GERD) and sleep. Three new studies in Clinical Gastroenterology and Hepatology explore GERD's effect on sleep quality and the health-care system as well as how a widely prescribed sleeping pill may mask the disease.

1 Sep 2009

Sexual impairment common among men undergoing chronic hepatitis C treatment

Sexual impairment is common among men with chronic hepatitis C undergoing antiviral therapy, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

1 Sep 2009

Fernando Pisani and 24 hockey players helped raise funds and awareness about Crohn's disease and ulcerative colitis

The spirit of giving back was as strong as ever this weekend at the first ever Score for Colitis & Crohn's event, which raised $20,000 for four gastrointestinal and digestive disease patient organizations from across the country. The Score for Colitis & Crohn's initiative, which took place at the West Edmonton Mall's Ice Palace on Saturday, August 29th, featured Fernando Pisani of the Edmonton Oilers and 24 aspiring young hockey enthusiasts who were all on hand to help raise funds and awareness about Crohn's disease and ulcerative colitis, the latter of which Pisani was diagnosed with in 2007.

31 Aug 2009

High dosage of ursodeoxycholic acid does not help PSC patients

A national team of researchers led by scientists at Mayo Clinic has found that a common treatment for primary sclerosing cholangitis, a chronic liver disease, is not helpful for patients, according to a study published this month in the journal Hepatology.

29 Aug 2009

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

28 Aug 2009

Ipsen Group announces first-half 2009 financial results

The Board of Directors of Ipsen (Paris:IPN), chaired by Jean-Luc Bélingard, met on 27 August 2009 to review the Group’s results for the first half 2009, published today. The full 2009 half year financial report is available on the Group’s web site, www.ipsen.com, under the Regulated Information heading in the Investor Relations pages.

28 Aug 2009

Forest Laboratories announces phase 3 trial results for roflumilast

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD.

28 Aug 2009

Forest Laboratories to host a conference call for discussing the results of Daxas Phase III clinical trials

Forest Laboratories, Inc., an international manufacturer and marketer of pharmaceutical products and Nycomed, a privately owned pharmaceutical company, will host a conference call at 7:15 AM EDT on Friday, August 28, 2009.

28 Aug 2009

Gastroenterology News and Research

Further Reading

METOZOLV drug approved for treating gastroesophageal reflux disease

Clinical study investigates laboratory and clinical implications of proton pump inhibitor drugs

Caldolor launched ahead of schedule in U.S. by Cumberland Pharmaceuticals

A voluntary recall program announced by CONMED Linvatec

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

First results of European survey of cancer patients' experience of breakthrough pain presented at EFIC

Study to test efficacy of lapatinib in advanced hepatocellular carcinoma

Regurin XL capsule for the treatment of OAB launched in UK

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Less-invasive, organ-sparing endoscopic therapy for treating early stages of esophageal cancer

NASDAQ Stock Market issues noncompliance letter to Encorium Group

Cumberland Pharmaceuticals to discuss its recently approved FDA product at the UBS Conference

Nighttime acid reflux symptoms impair sleep quality

Sexual impairment common among men undergoing chronic hepatitis C treatment

Fernando Pisani and 24 hockey players helped raise funds and awareness about Crohn's disease and ulcerative colitis

High dosage of ursodeoxycholic acid does not help PSC patients

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Ipsen Group announces first-half 2009 financial results

Forest Laboratories announces phase 3 trial results for roflumilast

Forest Laboratories to host a conference call for discussing the results of Daxas Phase III clinical trials

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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