Jaundice News and Research

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Jaundice, also known as icterus (attributive adjective: icteric), is a yellowish discoloration of the skin, the conjunctival membranes over the sclerae (whites of the eyes), and other mucous membranes caused by hyperbilirubinemia (increased levels of bilirubin in the blood).

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

Natus Medical ships ALGO hearing screeners to New South Wales

Natus Medical Incorporated today announced that it was awarded, and has shipped, a $1.3 million order for its ALGO hearing screeners from New South Wales, Australia's most populous state.

29 Dec 2010

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Vertex Pharmaceuticals Incorporated today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

22 Dec 2010

Natus Medical anticipates revenue of $247M to $250M for full year 2011

Natus Medical Incorporated today announced its financial guidance for the first quarter and full year 2011.

20 Dec 2010

Over quarter million women who gave birth in hospitals had pre-existing diabetes or developed gestational diabetes

More than a quarter million women who gave birth in U.S. hospitals in 2008 had pre-existing diabetes or developed it during their pregnancy - a condition called gestational diabetes, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. This equals 6.4 percent of the 4.2 million women who gave birth in that year.

17 Dec 2010

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE (bortezomib) in patients with relapsed multiple myeloma. These data were presented at the 52nd annual meeting of the American Society of Hematology, held December 4-7 in Orlando, Florida.

8 Dec 2010

Research shows anti-microbial medications lead to acute liver failure

New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected.

1 Dec 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Study investigates long-term outcome of REYATAZ/ritonavir regimens in ARV-experienced patients

Results from a European Observational Study, which included 1,294 antiretroviral (ARV)-experienced patients presented today at the Tenth International Congress on Drug Therapy in HIV Infection (HIV10), demonstrated a low rate of discontinuation and sustained virologic suppression with REYATAZ- (atazanavir)/ritonavir-based regimens over a follow-up period of up to five years.

11 Nov 2010

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Vertex Pharmaceuticals Incorporated today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2 clinical trial evaluating 12-week regimens of Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

10 Nov 2010

Combining telaprevir regimen with standard therapy improves SVR rate in hepatitis C

For patients with the most common form of hepatitis C being treated for the first time, the addition of an investigational hepatitis C-specific protease inhibitor called telaprevir to the current standard therapy markedly improved their sustained viral response (SVR or viral cure) rate.

3 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

New approach for early diagnosis of pancreatic cancer

Pancreatic tumors are one of the most lethal cancers, with fewer than five percent of patients surviving five years after diagnosis. But a new study that peers deeply into the genetics of pancreatic cancer presents a bit of good news an opportunity for early diagnosis. In contrast to earlier predictions, many pancreatic tumors are, in fact, slow growing, taking nearly 20 years to become lethal after the first genetic perturbations appear.

29 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 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

Royal Cornwall Hospital receives grant to study Hepatitis E

Researchers from the Royal Cornwall Hospital in Truro have received a grant of -337,000 to carry out a two-year study with partners in Glasgow and Norwich into a rare form of Hepatitis - Hepatitis E. The grant has come from the Chief Scientist's Office for Scotland and will be divided between the three centres taking part in the study.

18 Oct 2010

Natus announces acquisition of Medix

Natus Medical Incorporated today announced that it has acquired Medix, a leader in the development, manufacturing, and sales of devices for newborn care in Latin America. Medix, based in Argentina, manufactures incubators for use in hospital nurseries and neonatal intensive care units, transport incubators for use in ambulances and other emergency vehicles, infant warmers, and LED based phototherapy devices.

13 Oct 2010

FDA approves Roche's COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0

Roche Molecular Diagnostics announced today that the U.S. Food & Drug Administration (FDA) has approved the COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 for use in the United States. The new Roche test provides a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy.

23 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010