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.

Extension study data on Fampridine-SR drug

Data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment time of 36 months in study MS-F203EXT.

15 Sep 2009

Positive results from Merck's Phase IIB clinical study of odanacatib for treating osteoporosis

New data from a Phase IIB clinical study of odanacatib, Merck & Co., Inc.'s oral, once-weekly investigational treatment for osteoporosis, showed that when stopping treatment after two years, the increases in lower back (lumbar spine) bone mineral density (BMD) were reversed over the next year, while BMD at the hip (femoral neck) remained above levels observed at the start of the study.

15 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Acorda Therapeutics announces Phase 3 Fampridine-SR trial findings

Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

Lundbeck to launch Sabril in the US following FDA's NDA approval

Lundbeck Inc. (“Lundbeck”), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that the U.S. Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril® (vigabatrin) Tablets and Oral Solution. Lundbeck plans to launch Sabril in the United States in the third quarter.

24 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Genzyme’s Mozobil approved in Europe

Genzyme Corporation announced today that the European Commission has granted marketing authorization for Mozobil ® (plerixafor injection), providing a significant new option for patients with the blood cancers lymphoma and multiple myeloma who require an autologous stem cell transplant.

6 Aug 2009

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Cimzia approved in U.S. for rheumatoid arthritis

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

13 May 2009

Coartem tablets approved in U.S. to treat malaria

The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

8 Apr 2009

Amicus Therapeutics presents positive results from phase 2 extension study of Amigal for Fabry disease

Amicus Therapeutics has announced positive results from its ongoing Phase 2 extension study of its investigational drug, Amigal (migalastat HCL) for Fabry disease.

29 Mar 2009

Zometa (zoledronic acid) shown to enhance chemotherapy in reducing breast tumor size

New data released demonstrates that the addition of Zometa (zoledronic acid) injection to standard chemotherapy before breast cancer surgery reduces the size of breast tumors more effectively than chemotherapy alone in women with early-stage disease.

14 Dec 2008

Rituxan in combination with chemo improves survival in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone.

8 Dec 2008

Ustekinumab receives positive opinion in Europe for treatment of plaque psoriasis

Janssen-Cilag announced today that ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP).

24 Nov 2008

Nplate receives positive opinion for marketing authorisation in Europe

Amgen has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate (romiplostim) in the European Union (EU).

21 Nov 2008

Gleevec receives FDA priority review for gastrointestinal stromal tumors after surgery

Novartis has announced that Gleevec (imatinib mesylate) tablets, (known as Glivec (imatinib) outside the US, Canada and Israel), has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).

27 Aug 2008

Amgen announces positive results for Denosumab postmenopausal osteoporosis trial

Amgen has announced findings from the pivotal fracture trial evaluating its RANK Ligand inhibitor, denosumab, in the treatment of postmenopausal osteoporosis.

27 Jul 2008

FDA approves Actonel (risedronate sodium) for postmenopausal osteoporosis

The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis. Actonel is approved to reduce the risk of fractures in postmenopausal women with osteoporosis.

24 Apr 2008