Diarrhea News and Research

Latest Diarrhea News and Research

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

Pathogenic listeria tricks intestinal cells to cause sickness

Pathogenic listeria tricks intestinal cells into helping it pass through those cells to make people ill, and, if that doesn't work, the bacteria simply goes around the cells, according to a Purdue University study.

26 Oct 2010

LigoCyte presents Phase I/II study results of NoV vaccine for gastroenteritis at IDSA Meeting

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company developing innovative vaccine products, today announced positive results from a Phase I/II challenge study of its norovirus virus-like particle (VLP) vaccine candidate.

26 Oct 2010

Haiti cholera epidemic abates

The rate of deaths in Haiti's cholera epidemic slowed on Monday. This followed a multinational medical operation scale up to limit the spread of an outbreak that has killed 259 people in the earthquake-hit country. However Haitian and international health authorities are still bracing for more cases before the epidemic is finally controlled. So far, the epidemic has mostly impacted two rural central Haitian provinces, Artibonite and Center, along with the few isolated cases in the capital Port-au-Prince. Suspected cases have also been reported in the Nord and Sud provinces.

25 Oct 2010

Soligenix reports Phase 2 clinical trial results of orBec for GVHD

Soligenix, Inc. a late-stage biopharmaceutical company, today reported preliminary results from its Phase 2 "proof-of-concept" exploratory clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period.

25 Oct 2010

Childhood cancer survivors at increased risk of gastrointestinal problems

People treated for cancer when they were children have a higher-than-average risk of gastrointestinal problems - some mild, some quite severe - in the years following treatment, according to a study to be presented at the 42nd Congress of the International Society of Paediatric Oncology (SIOP) in Boston on Sunday, Oct. 24.

25 Oct 2010

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Optimer Pharmaceuticals, Inc. announced today the presentation of combined data from its two fidaxomicin Phase 3 trials in patients with Clostridium difficile infection (CDI) at the 48th Annual Meeting of the Infectious Disease Society of America (IDSA) in Vancouver, British Columbia, Canada.

25 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

Alexion 2010 third quarter revenue increases from $102.6 to $141.6 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and nine months ended September 30, 2010.

21 Oct 2010

Researchers to study effect of reovirus on cancer cells

A common virus that can cause coughing and mild diarrhea appears to have a major redemptive quality: the ability to kill cancer. Harnessing that power, researchers at Georgetown Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center, are conducting a clinical trial to see if the virus can target and kill certain tumor types.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Alexion Pharmaceuticals, Inc. today announced that its two open-label Phase 2 studies investigating eculizumab (Soliris) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) have met the primary and key secondary endpoints with high clinical and statistical significance, in interim analyses.

21 Oct 2010

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Genentech, a member of the Roche Group today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

21 Oct 2010

Cubist announces pricing of 2.50% Convertible Senior Notes due 2017

Cubist Pharmaceuticals, Inc. today announced the successful pricing of $400 million aggregate principal amount of its 2.50% Convertible Senior Notes due 2017. Cubist has granted the underwriters an option to purchase up to an additional $50 million aggregate principal amount of the notes.

20 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

Researchers explore impact of various factors on increasing rates of Clostridium difficile infection

In five different studies presented at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, researchers explored the impact of various factors on increasing rates of Clostridium difficile infection (C. difficile), such as the use of proton pump inhibitors (PPIs) and the substantial increase in antibiotic use due to new National Hospital Quality Measures; strategies to combat high rates of C. difficile infections; and cutting‐edge treatments for this potentially deadly-and quite common-infection.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010