Hyperbilirubinemia News and Research

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Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

30 Nov 2012

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Exelixis, Inc. today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

29 Nov 2012

$Neonatal history must be taken in ex-preterms with fractures$

Neonatal history must be taken in ex-preterms with fractures

Researchers say that a neonatal history must be taken in all ex-preterm infants with rib fractures.

26 Nov 2012

Lilly, Kowa announce results from PREVAIL U.S. study

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company today announced results of the PREVAIL U.S. study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which evaluated the efficacy of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.

2 Jun 2012

New data from descriptive sub-analysis of patients with compensated liver cirrhosis

New data from a descriptive sub-analysis of patients with compensated liver cirrhosis show that up to 43 percent of genotype-1a (GT1a) and up to 71 percent of GT1b hepatitis C virus (HCV) patients achieved sustained viral response (SVR12). SVR12 has been highly correlated with SVR24, which is a recognized indicator of viral cure.

20 Apr 2012

Bristol-Myers Squibb announces results from daclatasvir plus asunaprevir Phase II HCV study

Bristol-Myers Squibb Company today announced results from a Phase II study in which treatment with an all-oral, dual direct-acting antiviral (DAA) regimen of daclatasvir, an investigational NS5A replication complex inhibitor, and asunaprevir, an investigational NS3 protease inhibitor, achieved undetectable viral load 24 weeks post-treatment (SVR24) in 77% (33/43) of difficult-to-treat genotype 1b hepatitis C (HCV) patients.

20 Apr 2012

Experimental drug helps patients with advanced colon cancer

According to results from a new clinical trial, an experimental cancer drug regorafenib appears to extend survival slightly in patients with metastatic colorectal cancer. Regorafenib is a so-called multikinase inhibitor, which targets several of the ways cancer develops and grows, researchers said.

19 Jan 2012

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

Merck, known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease.

3 Nov 2011

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

New data presented today at the 46th Annual Meeting of the European Association for the Study of the Liver demonstrate the antiviral activity of Boehringer Ingelheim's once-daily oral protease inhibitor, BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus, the most challenging genotype of HCV to treat.

1 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

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

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

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

FDA clears IL's new point-of-care total bilirubin assay

Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.

28 Jul 2010

Genetic test to predict newborns requiring hospital readmission shortly after birth

The results of two separate research studies taking place at Children's Mercy Hospitals and Clinics will help physicians use genetic testing to prevent complications, and ease the worry of new parents by predicting in advance which newborns may require readmission to the hospital shortly after birth. The studies also will help physicians identify which of their young patients are likely to respond well - or not - to steroid therapy for asthma.

29 Apr 2010

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Many of the world's leading experts in pediatric pharmacogenomics and personalized medicine are gathering today at a first-of-its-kind conference in Kansas City to change the way childhood diseases and illnesses are treated.

29 Apr 2010

Hyperbilirubinemia News and Research

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Neonatal history must be taken in ex-preterms with fractures

Lilly, Kowa announce results from PREVAIL U.S. study

New data from descriptive sub-analysis of patients with compensated liver cirrhosis

Bristol-Myers Squibb announces results from daclatasvir plus asunaprevir Phase II HCV study

Experimental drug helps patients with advanced colon cancer

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

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

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

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

FDA clears IL's new point-of-care total bilirubin assay

Genetic test to predict newborns requiring hospital readmission shortly after birth

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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