Arthralgia News and Research

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Arthralgia is a symptom of injury, infection, illnesses - in particular arthritis - or an allergic reaction to medication. According to MeSH, the term "arthralgia" should only be used when the condition is non-inflammatory, and the term "arthritis" should be used when the condition is inflammatory.

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 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

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Clinical trial shows dalfampridine tablets improve walking ability in MS patients

Acorda Therapeutics, Inc. today announced that data from the second of two pivotal dalfampridine extended release tablets Phase 3 clinical trials in multiple sclerosis (MS) were published in the October 2010 edition of Annals of Neurology.

18 Nov 2010

Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

Amgen Inc. today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). The study results, which were published today in the New England Journal of Medicine (NEJM), show that both the incidence of treatment failure and need for splenectomy were reduced among the Nplate-treated patients.

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

Joint complaints attributed to breast cancer drugs not linked with inflammatory arthritis or autoimmune disease

A new study suggests joint complaints attributed to aromatase inhibitors (AI), popular breast cancer drugs, are not associated with inflammatory arthritis or autoimmune disease. Because of that, researchers say women who were primarily concerned about the threat of arthritis should be encouraged to continue taking the medication. The findings of the study will be presented Tuesday, Nov. 9 at the 74th Annual Scientific Meeting of the American College of Rheumatology in Atlanta, Georgia

9 Nov 2010

Synta reports $10.3M net loss for third quarter 2010 vs. $118.1M net income for third quarter 2009

4 Nov 2010

GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the Gynecologic Oncology Group (GOG) will initiate a Phase 2 clinical trial of elesclomol in combination with paclitaxel for the treatment of persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.

1 Nov 2010

GSK and Amicus announce Amigal development and commercialization agreement

GlaxoSmithKline PLC (GSK) and Amicus Therapeutics today announced a definitive agreement to develop and commercialize Amigal™ (migalastat HCl), currently in Phase 3 for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, GSK will receive an exclusive worldwide license to develop, manufacture and commercialize migalastat HCl.

29 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Abbott presents data from 4 briakinumab pivotal studies in psoriasis

In four separate pivotal clinical studies presented on Friday, a greater percentage of moderate to severe chronic plaque psoriasis patients treated with briakinumab, Abbott's investigational IL-12/23 inhibitor (ABT-874), achieved 75 percent or better skin clearance rates than those treated with etanercept (Enbrel®), methotrexate or placebo. Abbott presented data from all briakinumab pivotal studies in psoriasis at the European Association of Dermatology and Venereology scientific sessions.

11 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Three-year efficacy data on STELARA for psoriasis presented at American Academy of Dermatology meeting

New study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® (ustekinumab) sustained a clinical response for up to three years with continued treatment regardless of their body weight. Investigators also presented findings from an integrated safety analysis that included data from one Phase 2 and three Phase 3 trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment, consistent with previous analyses.

10 Aug 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Studies reveal impact and spread of CVBDs worldwide

Fascinating studies giving new insights into the spread of leishmaniosis in the UK and France, the appearance of new CVBDs in Germany, the state of heartworm infection in Korea and the neurological impact on humans of long-term bartonella infection from the USA are among the papers now available for download from http://www.cvbd.org, as the proceedings of the 5th Annual Canine Vector Borne Disease (CVBD) World Forum are made available online today.

28 Jul 2010