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.

Takeda announces publication of data from two vedolizumab Phase 3 studies for ulcerative colitis and Crohn’s disease

Takeda Pharmaceutical Company Limited today announced that results from two Phase 3 studies evaluating vedolizumab, an investigational humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, were published in the August 22, 2013 issue of the New England Journal of Medicine.

22 Aug 2013

Second GSK intramuscular quadrivalent influenza vaccine approved by the FDA

GlaxoSmithKline plc [LSE/NYSE: GSK] announced that the U.S. Food and Drug Administration (FDA) has approved FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine) for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine.

19 Aug 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

Spectrum Pharmaceuticals enters into agreement to acquire Talon Therapeutics

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.

17 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

From Baxter International Inc. 5 Jul 2013

EC grants marketing authorization for XTANDI capsules for treating advanced prostate cancer

Astellas Pharma Europe Ltd., the European Headquarters of Tokyo-based Astellas Pharma Inc. (TSE:4503), and Medivation, Inc. announced that following the regulatory review process by the European Medicines Agency (EMA) and a positive opinion from the Committee for Medicinal Products for Human Use on April 25, 2013, the European Commission (EC) has granted the marketing authorization for XTANDI™ (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

24 Jun 2013

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

Xgeva receives FDA approval for treating giant cell tumor of the bone

The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually non-cancerous tumor.

14 Jun 2013

Astellas submits application for marketing approval of enzalutamide for prostate cancer

Astellas Pharma Inc. and Medivation, Inc. today announced that Astellas has submitted an application for marketing approval of enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer.

24 May 2013

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

Phase IIb Aviator study demonstrates high SVR rates against genotype 1 HCV

Results from "Aviator," AbbVie's phase IIb clinical trial of its investigational direct-acting antivirals for the treatment of hepatitis C virus infection, continue to demonstrate high sustained viral response rates against genotype 1 HCV, across patient types.

24 Apr 2013

New data on Enanta's lead HCV protease inhibitor to be presented at International Liver Congress

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, announced today that new Phase 2b data related to ABT-450, Enanta's lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, as well as new preclinical data on Enanta's proprietary cyclophilin inhibitor, EDP-546, will be presented at the International Liver Congress, which is the 48th Annual Meeting of the European Association for the Study of the Liver taking place in Amsterdam April 24-28, 2013.

23 Apr 2013

Acorda Therapeutics reports positive data from dalfampridine-ER post-stroke deficits trial

Acorda Therapeutics, Inc. today announced that a proof-of-concept trial found dalfampridine extended release tablets, marketed as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits.

16 Apr 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

Positive new data from Genzyme’s eliglustat tartrate Phase 3 studies on Gaucher disease type 1

Genzyme, a Sanofi company, today announced positive new data from the Phase 3 ENGAGE and ENCORE studies of eliglustat tartrate, its investigational oral therapy for Gaucher disease type 1.

15 Feb 2013

Biogen Idec, Sobi release data from rFVIIIFc and rFIXFc phase 3 trials on hemophilia

Biogen Idec and Swedish Orphan Biovitrum (Sobi) released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia.

10 Feb 2013

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMROTM (mipomersen sodium) injection.

30 Jan 2013

STA announces results from ABRAXANE plus gemcitabine phase III trial on pancreatic cancer

Australian biopharmaceutical company Specialised Therapeutics Australia announces that a phase III clinical trial of world leading breast cancer drug ABRAXANE (nanoparticle albumin-bound paclitaxel) in combination with current standard of care gemcitabine in patients with advanced pancreatic cancer has demonstrated substantially improved survival times, with double the number of patients surviving two years.

23 Jan 2013

GSK receives FDA approval for FLUARIX QUADRIVALENT to treat seasonal flu

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.

17 Dec 2012