Arthralgia News and Research RSS Feed - Arthralgia News and Research

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.
Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p). [More]
Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen today announced that the U.S. Food and Drug Administration has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. [More]
Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Nektar Therapeutics reported that partner Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. [More]
Sanofi, Genzyme announce FDA approval of Lemtrada for treatment of relapsing forms of MS

Sanofi, Genzyme announce FDA approval of Lemtrada for treatment of relapsing forms of MS

Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. [More]
Janssen working with The Union to evaluate SIRTURO (bedaquiline) in patients with MDR-TB

Janssen working with The Union to evaluate SIRTURO (bedaquiline) in patients with MDR-TB

Janssen Research & Development, LLC today announced a collaboration with the International Union Against Tuberculosis and Lung Disease (The Union) to include SIRTURO (bedaquiline) in the STREAM Study. [More]
Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim today announced that Striverdi Respimat (olodaterol) Inhalation Spray 5 mcg is now available by prescription in pharmacies across the United States. [More]
GSK reports 45% survival rate in phase III study of Tafinlar in BRAF V600E mutant metastatic melanoma

GSK reports 45% survival rate in phase III study of Tafinlar in BRAF V600E mutant metastatic melanoma

GSK today announced updated results for Tafinlar (dabrafenib) from a planned analysis of the phase III BREAK-3 study in 250 patients with BRAF V600E mutant metastatic melanoma. [More]
Ampio updates phase III, multicenter, double-blind STEP study of Ampion for knee osteoarthritis

Ampio updates phase III, multicenter, double-blind STEP study of Ampion for knee osteoarthritis

Ampio Pharmaceuticals, Inc. today announced an update on the phase III, multicenter, double-blind STEP study of Ampion™ for osteoarthritis of the knee. [More]
Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm. [More]
Phase 3 ASPIRE clinical trial meets primary endpoint of progression-free survival

Phase 3 ASPIRE clinical trial meets primary endpoint of progression-free survival

Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). [More]
GSK announces availability of once-weekly Tanzeum in pharmacies throughout the U.S.

GSK announces availability of once-weekly Tanzeum in pharmacies throughout the U.S.

GSK today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S. [More]
GSK begins shipment of flu vaccines to U.S. for the upcoming 2014-15 season

GSK begins shipment of flu vaccines to U.S. for the upcoming 2014-15 season

GSK announced today it has begun shipping FLUARIX QUADRIVALENT (Influenza Vaccine) doses to U.S. healthcare providers. This is the first shipment of GSK’s U.S. flu vaccine supply for the flu season, following licensing and lot-release approval from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research. [More]
UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology. [More]
FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval. [More]
ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD Pharmaceuticals, Inc. today announced, for the first time, data from its Phase 2 trial of Iclusig (ponatinib) in adult patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors (GIST). [More]
FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., has announced that the United States (U.S.) Food and Drug Administration (FDA) simultaneously approved a new biologic therapy, Entyvio™ (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). [More]
Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. [More]
Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. [More]
Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. [More]
Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen (NASDAQ: AMGN) today announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol. [More]