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.

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Celgene announces interim results of REVLIMID study on CLL

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

12 Dec 2011

FDA approves changes to REMS for Nplate and Promacta

The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration.

7 Dec 2011

FDA modifies requirements of Amgen's Nplate REMS Program

Amgen today announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate (romiplostim) Risk Evaluation and Mitigation Strategy (REMS) Program.

7 Dec 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

New data from Novartis' ACZ885 Phase III study on SJIA

Novartis announced today new pivotal Phase III data showing 45% of children with active systemic juvenile idiopathic arthritis (SJIA) were able to substantially reduce their use of oral corticosteroids (often described as steroids) within 28 weeks of commencing treatment with ACZ885.

7 Nov 2011

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

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

Ferring reports on FDA approval of labeling supplement for EUFLEXXA to treat knee osteoarthritis

On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

22 Oct 2011

JCO publishes data from Celgene's ABRAXANE Phase II combination trial on pancreatic cancer

Celgene International Sàrl today announced that results from a clinical study of ABRAXANE in combination with gemcitabine in 67 patients with previously untreated advanced pancreatic cancer were published in an online article by the Journal of Clinical Oncology ahead of print.

7 Oct 2011

Long-term results from ARIAD's ponatinib Phase 1 study on CML and Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced long-term results of the Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia.

26 Sep 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Amgen's Prolia receives FDA approval for new indications to treat cancer patients

Amgen today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

19 Sep 2011

Health Canada grants market authorization for Sanofi-aventis Jevtana to treat prostate cancer

Sanofi-aventis announced today that Health Canada has granted market authorization for Jevtana injection in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing treatment regimen.

24 Jun 2011

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene International Sàrl announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

18 Jun 2011

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

Groupe d'Etude des Lymphomes de l'Adulte (GELA) and Celgene International Sarl today announced a collaboration to conduct an international randomized study to evaluate the therapeutic potential of the REVLIMID/rituximab combination regimen (R2) in patients with newly diagnosed follicular lymphoma.

17 Jun 2011

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

Celgene International Sàrl announced that clinical data from two studies evaluating the use of REVLIMID® (lenalidomide) with standard R-CHOP chemotherapy in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

17 Jun 2011

ABRAXANE and bevacizumab clinical studies on unresectable melanoma presented at ASCO 2011

Celgene International Sàrl today announced that results from two investigator initiated studies including ABRAXANE, and bevacizumab in unresectable melanoma were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, IL.

7 Jun 2011

Initial positive results from ZIOPHARM's ZIN-CTI-001 Phase Ib study against advanced melanoma

ZIOPHARM Oncology, Inc. announced today that Douglas J. Schwartzentruber, MD, FACS, of the Indiana University Health Goshen Center for Cancer Care, presented initial positive clinical results from the first-ever treatment demonstrating control over transgene encoding of a therapeutic anticancer protein in humans using a small molecule activator ligand.