Diarrhea News and Research

Latest Diarrhea News and Research

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

Amgen announces PRIME '203' and '181' Phase 3 trial results

Amgen today announced that results from the PRIME '203' and '181' pivotal Phase 3 trials evaluating Vectibix (panitumumab) in combination with chemotherapy (FOLFOX or FOLFIRI) as a first and second-line treatment for metastatic colorectal cancer (mCRC), respectively, were published online in the Journal of Clinical Oncology.

5 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

CPS recommends all Canadian babies should be vaccinated against rotavirus

All Canadian babies should be vaccinated against rotavirus, according to a new statement by the Canadian Paediatric Society. The CPS is also calling for public funding of the vaccine, which is not currently covered by provincial or territorial health plans.

5 Oct 2010

Egg allergies may be prevented by early introduction: Study

Contrary to popular belief that eggs should not be introduced into the diet before the first birthday of the baby, a new study shows that parents who do not want their newborn babies to develop an egg allergy ought to feed them eggs in the first six months of life.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

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

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., today announced that it has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

1 Oct 2010

Prix Galien USA committee honors life saving innovations

The Prix Galien USA committee honored innovations that are saving lives last night during the Prix Galien Awards Gala. The Pro Bono Humanum Award, the Prix Galien USA 2010 and the Prix Galien International were presented and related accomplishments celebrated.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 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

Precautionary guidelines on flu vaccine safety for allergic children

With the flu season looming and health officials calling for across-the-board immunization, some parents may wonder just how safe the egg-based flu vaccine is for children with allergies. Pretty safe, say pediatricians from Johns Hopkins Children's Center: Even though the flu vaccine contains egg protein, most children with egg and other food allergies can be immunized safely with a few basic precautions.

30 Sep 2010

Outbreak of whooping cough mirrors challenges in developing world, global health official says

The outbreak of whooping cough in Texas, California, and other states this year underscores the critical importance of widespread vaccination coverage, both locally as well as around the world, said a leading global health official attending conferences on world affairs and immunization in Fort Worth this week.

29 Sep 2010

Tamir's compounds perform better than Ganciclovir for Cytomegalovirus disease: Study

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds outperformed market leader Roche's drug Ganciclovir in cell culture and plaque reduction assay (the gold standard) for Cytomegalovirus (CMV) disease. Additionally, antiviral activity was also apparent against other human herpesviruses, namely, HSV-1 (cold sores), HSV-2 (genital herpes), and Varicella-Zoster Virus (VZV) (chicken-pox and shingles).

29 Sep 2010

Mucosis collaborates with PATH to pursue use of Mimopath technology in diarrhea vaccines

Dutch biotechnology company Mucosis B.V. announced today that it has entered into a collaboration agreement with the global health nonprofit organization PATH to pursue the use of the company's Mimopath technology in oral vaccines to prevent and treat severe diarrhea.

28 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

Bayer’s new oral contraceptive receives FDA approval

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved a new oral contraceptive, Beyaz (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets).

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