Constipation News and Research

Latest Constipation News and Research

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories. These pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

30 Sep 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.

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

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

Today Phadia announced that it has received FDA 510(k) clearance for two new, CLIA Moderate Complexity, EliA autoimmune antibody assays. The new assays will provide physicians with additional tools needed to aid in the diagnosis of Celiac disease. The newly available assays, EliA GliadinDP IgA and EliA GliadinDP IgG (deamidated peptides), have proven to be essential, sensitive and specific markers to aid in the diagnosis of celiac disease.

22 Sep 2010

VIVUS announces QNEXA study results for obesity treatment

VIVUS, Inc. today announced positive top-line results from a two-year study of QNEXA(phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.

21 Sep 2010

Oxy-Powder supplement clears clinical trials for Irritable Bowel Syndrome

The popular nutraceutical health supplement, Oxy-Powder has passed clinical trials for Irritable Bowel Syndrome (IBS) with a 99.9 percent success rate.According to the NIH, approximately 20% of Americans suffer from the symptoms of IBS, which qualifies it as one of the most common medical problems in the United States.

21 Sep 2010

Bedwetting increases during start of school period

Bedwetting perennially drives parents to the pediatric urology clinic at Johns Hopkins Children's Center, but September — and the start of the school year — always brings a predictable uptick in visits, according to pediatric urologist Ming-Hsien Wang, M.D.

21 Sep 2010

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

Genentech, Inc., a member of the Roche Group, today announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment.

18 Sep 2010

Opiate usage increases in workplace and ER

More American workers and job applicants are testing positive for prescription opiates, according to U.S. general workforce data in the 2009 annual Drug Testing Index™ (DTI) released today by Quest Diagnostics Incorporated, the nation's leading provider of diagnostic testing, information and services. Results from more than 5.5 million urine drug tests reveal an 18 percent jump in opiate positives in the general U.S. workforce in a single year (2008 to 2009), and a more than 40 percent climb from 2005 to 2009.

17 Sep 2010

Abbott issues statement in response to FDA's mixed vote for weight loss medication sibutramine

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT and the weight loss medication sibutramine (sold as Meridia® in the United States).

16 Sep 2010

AMRI selects compound for advanced preclinical testing in treatment of IBS

AMRI today announced the selection of a compound from its proprietary research program for the treatment of irritable bowel syndrome (IBS) for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2011.

15 Sep 2010

$Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy$

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA™ (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

15 Sep 2010

FDA approves Krystexxa drug to treat gout

The U.S. Food and Drug Administration approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

15 Sep 2010

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Progenics Pharmaceuticals, Inc. today presented preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile.

14 Sep 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

Constipation News and Research

Latest Constipation News and Research

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Celiac disease on the rise in adults: Study

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

VIVUS announces QNEXA study results for obesity treatment

Oxy-Powder supplement clears clinical trials for Irritable Bowel Syndrome

Bedwetting increases during start of school period

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

Opiate usage increases in workplace and ER

Abbott issues statement in response to FDA's mixed vote for weight loss medication sibutramine

AMRI selects compound for advanced preclinical testing in treatment of IBS

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

FDA approves Krystexxa drug to treat gout

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Clue's CEO Rhiannon White on the Future of Femtech and PCOS

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Precision in every drop: Inside Hamilton’s syringe technology

Constipation News and Research

Latest Constipation News and Research

Clue's CEO Rhiannon White on the Future of Femtech and PCOS

Freezing Point Osmometry in Life Science Applications

Precision in every drop: Inside Hamilton’s syringe technology

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