Lupus Erythematosus News and Research

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SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

New research finds pattern for detecting 'false-positive' ANA results

The presence of antinuclear antibodies (ANA) indicates the possibility of autoimmunity and the indirect immunofluorescence (IIF) assay on HEp-2 cells is the standard blood test (ANA-HEp-2) used to detect ANA. However, studies have shown that a "false-positive" ANA test occurs in up to 13% of healthy individuals. In such cases the test detects the presence of autoantibodies that apparently are not associated with autoimmunity.

4 Jan 2011

Study reveals immune cell provides new therapeutic strategy for SLE

A new study provides fascinating insight into the underlying pathology associated with the autoimmune disease, systemic lupus erythematosus.

16 Dec 2010

Immunomedics, UCB initiate enrollment in EMBODY 1 epratuzumab Phase III study in SLE

Immunomedics Inc. and UCB today announced the enrollment of the first patient into EMBODY™ 1, one of two pivotal Phase III studies of epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE). Patient enrollment for EMBODY™ 2 has also begun.

14 Dec 2010

Research: Kidney disease caused by autoimmune disease lupus may be twice as lethal in children

Kidney disease caused by the autoimmune disease lupus may be twice as lethal in children as kidney disease caused by other disorders, according to research led by Johns Hopkins Children's Center investigators.

13 Dec 2010

FDA extends PDUFA review target date for BENLYSTA BLA to treat systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for BENLYSTA® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from December 9, 2010 to March 10, 2011.

4 Dec 2010

Acthar Gel may be a viable treatment option for resistant nephrotic syndrome

On November 20 at the American Society of Nephrology 43rd Annual Meeting, Columbia University Assistant Professor of Clinical Medicine Andrew Bomback, MD, presented results from a patient case series assessing the potential therapeutic value of H.P. Acthar Gel (repository corticotropin injection) as a treatment for patients with nephrotic syndrome, a kidney disorder characterized by excessive loss of urinary protein.

22 Nov 2010

LRI pleased with FDA Advisory Committee's approval of Benlysta for lupus

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations are pleased with the U.S. Food and Drug Administration (FDA) Advisory Committee's vote to recommend approval of Benlysta® for active systemic lupus erythematosus (SLE), offering patients new found hope for the first approved treatment option in more than 50 years.

17 Nov 2010

FDA Arthritis Advisory Committee recommends approval of BENLYSTA for SLE

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).

17 Nov 2010

Anthera places voluntary hold on A-623 Phase 2b study for lupus

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that it has notified the US Food and Drug Administration (FDA) that the company has placed a voluntary hold on PEARL-SC, the Phase 2b study of A-623 for the treatment of Systemic Lupus Erythematosus (lupus), due to problems found with product vials.

17 Nov 2010

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

Resolve Therapeutics enters license with University of Washington for autoimmune disease treatment

Resolve Therapeutics, LLC today announced that it has entered into an exclusive license with the University of Washington for certain biologic compounds and technology developed to treat autoimmune diseases including systemic lupus erythematosus (SLE).

11 Nov 2010

Myrexis presents key preclinical findings of MPI-0485520 at ACR/ARHP meeting

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today presented key preclinical findings of the Company's novel oral anti-interferon, MPI-0485520, at the 74th Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, in Atlanta, Georgia.

10 Nov 2010

Epratuzumab reduces SLE disease activity in phase IIB EMBLEM study

UCB and U.S. based partner Immunomedics Inc. announced that results from the phase IIB study, EMBLEM, showed that certain doses of epratuzumab were associated with a meaningful and statistically significant reduction in disease activity in adult patients with moderate to severe active SLE.

10 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

People with SLE more likely to develop hematologic malignancies

People with systemic lupus erythematosus are 1.15 times as likely to develop cancer as the general population and more than 2.5 times as likely to develop hematologic malignancies, such as lymphoma and leukemia, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

8 Nov 2010

Statin drugs do not benefit pediatric lupus patients

Lupus puts children at higher risk for coronary artery disease when they become adults, but routinely using statins doesn't provide enough benefit to warrant their regular use in children and adolescents, according to the largest study of pediatric lupus patients to date.

8 Nov 2010

APS summit focuses on Antiphospholipid Syndrome research

Antiphospholipid Syndrome (APS) is a condition that may be responsible for up to one-third of strokes in people under age 50, up to one-fifth of all cases of blood clots in large veins, and one-quarter of recurrent miscarriages. Nonetheless, relatively few randomized clinical trials have been conducted involving people with APS, and those completed have included small numbers of participants.

3 Nov 2010

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Celgene Corporation announced non-GAAP net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010.

28 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010