Diarrhea News and Research

Latest Diarrhea News and Research

FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Clinical Data, Inc. today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company's selective serotonin 2B (5-HT2B) receptor antagonist.

1 Nov 2010

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Vertex Pharmaceuticals Incorporated today announced new data from its Phase 3 studies of people with genotype 1 chronic hepatitis C who have not been treated previously. In these studies, the majority of people achieved superior sustained viral response (SVR or viral cure) rates with a telaprevir-based combination regimen, compared to current therapies, regardless of race/ethnicity or stage of liver fibrosis (factors known to limit response to current hepatitis C treatments).

1 Nov 2010

Boehringer to present data of SOUND-C1 Phase Ib study for HCV treatment at AASLD Meeting

Boehringer Ingelheim announced results from a Phase Ib study, SOUND-C1, that showed the combination of two oral hepatitis C virus (HCV) compounds, the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, with ribavirin reduced viral load to the lower limit of quantifiable levels in HCV treatment-naïve patients.

1 Nov 2010

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

Gilead presents Phase IIa data for HCV therapy at The Liver Meeting 2010

Gilead Sciences, Inc. today announced data from a Phase IIa study showing that its investigational compounds GS 9190 and GS 9256, used in conjunction with current standard of care therapies, produced substantial suppression of the hepatitis C virus (HCV) within 28 days of treatment.

1 Nov 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

30 Oct 2010

Teflaro receives FDA approval for treatment of bacterial infections

The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

GSK and Amicus announce Amigal development and commercialization agreement

GlaxoSmithKline PLC (GSK) and Amicus Therapeutics today announced a definitive agreement to develop and commercialize Amigal™ (migalastat HCl), currently in Phase 3 for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, GSK will receive an exclusive worldwide license to develop, manufacture and commercialize migalastat HCl.

29 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

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

Diarrhea News and Research

Latest Diarrhea News and Research

FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Boehringer to present data of SOUND-C1 Phase Ib study for HCV treatment at AASLD Meeting

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead presents Phase IIa data for HCV therapy at The Liver Meeting 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

FDA approves NUEDEXTA capsules for pseudobulbar affect

Teflaro receives FDA approval for treatment of bacterial infections

GSK and Amicus announce Amigal development and commercialization agreement

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

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

Sandoz initiates voluntary recall of Methotrexate Injection

Pathogenic listeria tricks intestinal cells to cause sickness

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

Haiti cholera epidemic abates

Soligenix reports Phase 2 clinical trial results of orBec for GVHD

Childhood cancer survivors at increased risk of gastrointestinal problems

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

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

Diarrhea News and Research

Latest Diarrhea News and Research

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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