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.

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.

30 Sep 2014

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.

2 Sep 2014

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.

From Baxter International Inc. 22 Aug 2014

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).

4 Aug 2014

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.

29 Jul 2014

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.

17 Jul 2014

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.

3 Jul 2014

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.

9 Jun 2014

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).

2 Jun 2014

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).

21 May 2014

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.

21 Apr 2014

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.

8 Apr 2014

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.

4 Apr 2014

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.

31 Mar 2014

Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Today Biogen Idec announced that Health Canada has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B.

21 Mar 2014

Dendreon plans to make PROVENGE available in Europe

Dendreon Corporation today announced that it plans to make PROVENGE (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) available in Europe, beginning with Germany and the United Kingdom.

3 Mar 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

ARIAD Pharmaceuticals' Iclusig now commercially available to patients in the U.S.

ARIAD Pharmaceuticals, Inc. today announced the commercial availability of Iclusig (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

18 Jan 2014

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations.

9 Jan 2014

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014