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New SMILEY tool helps assess QoL of children with lupus

A newly designed tool is helping researchers shed light on the quality of life (QoL) of children with lupus around the world, according to research presented at the American College of Rheumatology (ACR) annual meeting, held Nov. 7-11, in Atlanta.

11 Nov 2010

Egrifta receives FDA approval for treatment of HIV-lipodystrophy

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

10 Nov 2010

Children with JIA face increase risk of developing cancer

Children with juvenile idiopathic arthritis have a two to threefold increased risk of developing cancer compared to similarly-aged children without JIA, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta. The same study also reported no cases of cancer in children with JIA who were exposed to anti-TNF therapy.

9 Nov 2010

Plexxikon's PLX4032 shows positive data in patients with metastatic melanoma

Plexxikon today announced positive preliminary data from a pivotal Phase 2 clinical trial of PLX4032 (RG7204) in metastatic melanoma, showing significant tumor shrinkage in the majority of patients.

8 Nov 2010

Hydroxychloroquine may reduce cardiac neonatal lupus in subsequent pregnancies: Research

Women with anti-SSA/Ro antibodies and a previous child who has heart block a condition where the electrical signal that makes the heart beat is damaged may potentially decrease their risk of delivering another child with life threatening heart disease by taking hydroxychloroquine (Plaquenil), according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

8 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

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

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

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

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

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

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

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

Tips to prevent lead poisoning in children

California Poison Control System is observing National Lead Poisoning Prevention Week and warns consumers that lead can be found in a variety of products available to children.

27 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

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

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

More education and attention needed on inflammatory breast cancer

Inflammatory breast cancer (IBC), an aggressive and rare malignancy, is often initially misdiagnosed as an infection or rash. However, getting the correct diagnosis quickly is critical for patients because the disease spreads beyond the breast in a matter of just days or weeks.

20 Oct 2010

ISI launches initiative to create translation glossary for healthcare providers

Phrases like "Grandfathered Health Plan" or "Biosimilar Biological Products" are hard enough to understand in English, let alone trying to accurately translate those concepts into Spanish, Chinese or any other of the dozens of languages in which healthcare providers must communicate.

19 Oct 2010

Rash News and Research

New SMILEY tool helps assess QoL of children with lupus

Egrifta receives FDA approval for treatment of HIV-lipodystrophy

Children with JIA face increase risk of developing cancer

Plexxikon's PLX4032 shows positive data in patients with metastatic melanoma

Hydroxychloroquine may reduce cardiac neonatal lupus in subsequent pregnancies: Research

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

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

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

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

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

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Teflaro receives FDA approval for treatment of bacterial infections

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

Tips to prevent lead poisoning in children

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

FDA approves REMS for NUVIGIL and PROVIGIL tablets

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

More education and attention needed on inflammatory breast cancer

ISI launches initiative to create translation glossary for healthcare providers

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