Gastroenterology News and Research

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

FDA approves Warner Chilcott's ACTONEL for postmenopausal osteoporosis

Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its next generation ACTONEL® (risedronate sodium) product for the treatment of postmenopausal osteoporosis in the United States. The product will be marketed as ATELVIA™ (risedronate sodium) delayed-release tablets.

11 Oct 2010

IV ibuprofen effective in reducing fever in hospitalized patients

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.

8 Oct 2010

Study shows radioembolisation with TheraSphere effective for primary liver cancer

MDS Nordion, a leading provider of products and services to the global health science market, today announced that the first large European study using Yttrium-90 (Y-90) glass microspheres has been published on the use of TheraSphere, an innovative radioembolisation therapy for the localised treatment of patients with advanced hepatocellular carcinoma (HCC) or primary liver cancer.

7 Oct 2010

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg gave improved bowel function in patients with chronic constipation.

6 Oct 2010

Optical technology shows potential for prescreening patients at high risk for lung cancer

Researchers from Northwestern University and NorthShore University HealthSystem (NorthShore) have developed a method to detect early signs of lung cancer by examining cheek cells in humans using pioneering biophotonics technology.

6 Oct 2010

Meda completes Alaven acquisition

Meda has completed the acquisition of Alaven and has taken over its operations. The acquisition will benefit Meda both short term and long term. The acquisition will add the therapeutic focus to include both gastroenterology and women's health; areas that Meda operates in outside of the US. In addition, Alaven has a strategic OTC platform that accounts for approximately 25% of sales. Alaven will further diversify Meda's revenue base in the US, as well as serve as a platform for commercializing strategic pipeline opportunities.

4 Oct 2010

BBPS tool can assess colon cleanliness during colonoscopy

Boston Medical Center (BMC) doctors have proven the reliability of the Boston Bowel Preparation Scale (BBPS), a tool that assesses the cleanliness of the colon during colonoscopies. This study, published in the October 2010 issue of the journal Gastrointestinal Endoscopy, demonstrates the scale's accuracy and could become an international standardized tool to rate colon cleanliness during colonoscopy.

4 Oct 2010

Sulindac drug derivative effective in preventing colon cancer: Research

Researchers in the Division of Cancer Prevention, Department of Medicine, at Stony Brook University have discovered that a novel derivative of sulindac, a non-steroidal anti-inflammatory drug (NSAID) known to prevent colon cancer, is more effective and safer than sulindac in preventing colon cancer in animals. The study results are reported in the October issue of the journal Gastroenterology.

3 Oct 2010

Encorium announces extension of expiration date for pending rights offering

Encorium Group, Inc. , 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 it has extended the expiration date for its pending rights offering from September 30, 2010 to October 15, 2010. The subscription rights may now be exercised at any time prior to 5:00 p.m. ET on Friday, October 15, 2010.

1 Oct 2010

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo® tablets.

1 Oct 2010

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

Repligen Corporation reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

30 Sep 2010

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

30 Sep 2010

USFDA approves Sun Pharmaceutical's ANDA to market Rilutek tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sanofi Aventis's Rilutek® tablets 50 mg.

29 Sep 2010

Study investigates link between cough and reflux events using sound recording device

Coughing episodes are closely related to gastroesophageal reflux symptoms in patients who experience chronic cough, irrespective of other diagnoses, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

28 Sep 2010

Global Health Partner acquires Stockholm Gastro Center

Global Health Partner (STO:GHP) has acquired Stockholm Gastro Center, a specialist clinic with operations within medical gastroenterology and endoscopy located at Sophiahemmet in Stockholm. "The acquisition of Stockholm Gastro Center is a good complement to the obesity surgery business that we run at Kirurgkliniken and Bariatric Center Stockholm in Sophiahemmet's facilities. This is a combination of businesses that we also have at our clinics in Lund and Prague and where we see good coordination and expansion opportunities," says Per Båtelson, Global Health Partner's CEO.

28 Sep 2010

Celiac disease on the rise in adults: Study

According to a new study published Monday in the Annals of Medicine, cases of intestinal disorder known as Celiac disease are on the rise with many adults developing the disease.

28 Sep 2010

Double-Balloon Enteroscopy shows potential benefits in children

The use of device assisted enteroscopy, a technique that allows complete examination of the small bowel, may be just as successful pediatrics as it has been in adult medicine, according to a study from Nationwide Children's Hospital.

27 Sep 2010

Warner Chilcott subsidiaries to issue $500 million of 7-3/4% senior notes in private placement

Warner Chilcott plc today announced that its subsidiaries, Warner Chilcott Company, LLC and Warner Chilcott Finance LLC (together, the "Issuers"), plan to issue an aggregate principal amount of $500 million of 7-3/4% senior notes due 2018 (the "Notes") in a private placement. The notes are additional notes constituting a part of the same series as the $750 million aggregate principal amount of 7-3/4% senior notes due 2018 issued on August 20, 2010.

24 Sep 2010

Warner Chilcott to acquire U.S. rights to Enablex from Novartis for $400 million

Warner Chilcott plc today announced that it has agreed to terminate its existing co-promotion agreement with Novartis and signed a definitive agreement to purchase the U.S. rights to Enablex® from Novartis for $400 million in cash. Enablex (darifenacin) is a product indicated to treat adults with symptoms of overactive bladder, which had U.S. sales of approximately $190 million for the year ended December 31, 2009.

24 Sep 2010

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited underscore the company’s commitment to ACTOS® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

24 Sep 2010

Gastroenterology News and Research

Further Reading

FDA approves Warner Chilcott's ACTONEL for postmenopausal osteoporosis

IV ibuprofen effective in reducing fever in hospitalized patients

Study shows radioembolisation with TheraSphere effective for primary liver cancer

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Optical technology shows potential for prescreening patients at high risk for lung cancer

Meda completes Alaven acquisition

BBPS tool can assess colon cleanliness during colonoscopy

Sulindac drug derivative effective in preventing colon cancer: Research

Encorium announces extension of expiration date for pending rights offering

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

USFDA approves Sun Pharmaceutical's ANDA to market Rilutek tablets

Study investigates link between cough and reflux events using sound recording device

Global Health Partner acquires Stockholm Gastro Center

Celiac disease on the rise in adults: Study

Double-Balloon Enteroscopy shows potential benefits in children

Warner Chilcott subsidiaries to issue $500 million of 7-3/4% senior notes in private placement

Warner Chilcott to acquire U.S. rights to Enablex from Novartis for $400 million

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

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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