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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

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Inhibitex, Inc. announced today that it has initiated a Phase 1b, multiple ascending dose (MAD) clinical trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic infections caused by hepatitis C virus (HCV).

1 Nov 2010

Global Genes Project launches new campaign to create awareness about rare diseases

The Global Genes Project, a non-profit advocacy organization that aims to raise awareness about the prevalence of rare diseases worldwide, today launched the 7,000 Bracelets for Hope campaign. The 7,000 Bracelets for Hope campaign is designed to draw attention to an estimated 7,000 different chronic, life-threatening and fatal rare diseases and disorders affecting approximately 30 million Americans and millions more globally.

1 Nov 2010

Clear guidelines needed for consistent diagnosis and treatment of childhood stroke

Researchers are calling for clear guidelines on childhood stroke after a study, published in the November issue of Acta Paediatrica, found wide variations in time lag to diagnosis, investigation and treatment.

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

Labtec initiates Sufentanil TDS phase II clinical development program for chronic cancer pain

Labtec GmbH, Langenfeld, Germany announces the start of the phase II clinical development program for its sufentanil transdermal patch. The multicentric, randomized, open label study will evaluate efficacy and safety of Sufentanil TDS against standard treatment in patients with chronic cancer pain.

1 Nov 2010

Medivir's partner Tibotec reports Week 24 interim results from TMC435 Phase 2b study in HCV

Medivir AB, the research-based speciality pharmaceutical company focused on the development of high-value treatments for infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, has announced the results of a Week-24 planned interim analysis of the Phase 2 response-guided PILLAR study for TMC435, Medivir's key pipeline asset, a hepatitis C protease inhibitor dosed once-daily.

1 Nov 2010

Intentional foreign body ingestion results in over $2 million hospital costs: Study

A new study from Rhode Island Hospital found that 33 individuals were responsible for 305 cases of medical intervention to remove foreign bodies that were intentionally swallowed, resulting in more than $2 million in estimated hospital costs. The findings appear in the November issue of Clinical Gastroenterology and Hepatology.

1 Nov 2010

Merck's boceprevir improves SVR rate in adults with chronic hepatitis C virus genotype 1 infection

Merck reported today that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, demonstrated significantly higher sustained virologic response (SVR) rates in adult patients who previously failed treatment (treatment-failure; HCV RESPOND-2) and in adult patients who were new to treatment for chronic hepatitis C virus (HCV) genotype 1 compared to control, the primary objective of the studies.

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

Idera presents IMO-2125 Phase 1 clinical trial data for HCV infection at AASLD Meeting

Idera Pharmaceuticals, Inc. announced today the presentation of data from a Phase 1 clinical trial evaluating IMO-2125, a novel immune modulator, in null-responder patients with chronic hepatitis C virus (HCV) infection.

1 Nov 2010

Tibotec to present Week-24 interim analysis of PILLAR study for chronic HCV treatment at AASLD Meeting

Tibotec Pharmaceuticals announced today the company will present the results of a Week-24 planned interim analysis of the phase 2 response-guided PILLAR study in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA., USA. The data will be presented as part of a late-breaker oral presentation on Monday, November 1.

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

Researchers generate bioengineered human liver organoid using bioscaffold

Researchers at Wake Forest University Baptist Medical Center's Institute for Regenerative Medicine demonstrated the generation of a bioengineered human liver organoid using a liver bioscaffold made from an intact liver extracellular matrix, and filled (seeded) with primary human liver progenitor and endothelial cells.

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

Anadys presents data of ANA598 for hepatitis C treatment at AASLD Annual Meeting

Anadys Pharmaceuticals, Inc. today announced the ANA598 data to be presented at the 61st Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston, MA.

1 Nov 2010

‘Off the shelf’ new livers from stem cells, glimmer of hope

A researcher team has successfully produced a small-scale version of a human liver in the laboratory using stem cells. This could be a boon for patients waiting for liver transplants although it will take years to perfect the procedure say researchers.

31 Oct 2010

Presidio to present PPI-461 data for HCV infection at AASLD meeting

Presidio Pharmaceuticals, Inc. announced today that Nathaniel Brown, M.D., Chief Medical Officer, will present a late-breaker poster, "Safety and Pharmacokinetics of PPI-461, a Potent New Hepatitis C virus (HCV) NS5A Inhibitor with Pan-Genotype Activity" at the 61st AASLD meeting in Boston, MA, on November 1, 2010.

30 Oct 2010

HDL and Virginia governor announce $4.2 million investment for expanding operations

Health Diagnostic Laboratory (HDL, Inc.) and Governor Bob McDonnell have announced an investment of $4.2 million in HDL, Inc. operations, resulting in the creation of 213 new jobs in the City of Richmond. HDL, Inc., located in the Virginia BioTechnology Research Park, will expand its clinical laboratory, diagnostics and clinical trial services, as well as its physician/patient consulting.

30 Oct 2010

Alnylam to present data on RNAi therapeutics for fibrotic diseases at The Liver Meeting

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it will present several poster presentations at the 61st Annual Meeting of the American Association for the Study of Liver Diseases being held in Boston, Mass from October 29 - November 2, 2010.

30 Oct 2010

Chronic News and Research

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

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Global Genes Project launches new campaign to create awareness about rare diseases

Clear guidelines needed for consistent diagnosis and treatment of childhood stroke

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

Labtec initiates Sufentanil TDS phase II clinical development program for chronic cancer pain

Medivir's partner Tibotec reports Week 24 interim results from TMC435 Phase 2b study in HCV

Intentional foreign body ingestion results in over $2 million hospital costs: Study

Merck's boceprevir improves SVR rate in adults with chronic hepatitis C virus genotype 1 infection

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

Idera presents IMO-2125 Phase 1 clinical trial data for HCV infection at AASLD Meeting

Tibotec to present Week-24 interim analysis of PILLAR study for chronic HCV treatment at AASLD Meeting

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

Researchers generate bioengineered human liver organoid using bioscaffold

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

Anadys presents data of ANA598 for hepatitis C treatment at AASLD Annual Meeting

‘Off the shelf’ new livers from stem cells, glimmer of hope

Presidio to present PPI-461 data for HCV infection at AASLD meeting

HDL and Virginia governor announce $4.2 million investment for expanding operations

Alnylam to present data on RNAi therapeutics for fibrotic diseases at The Liver Meeting

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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