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EMA CHMP issues positive opinion to Savient's KRYSTEXXA for treatment of chronic gout

Savient Pharmaceuticals, Inc. and its wholly owned subsidiary, Savient Pharma Ireland Limited, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.

19 Oct 2012

Two-part ACR guidelines on gout

Gout is one of the most common forms of inflammatory arthritis, affecting nearly 4% of adult Americans. Newly approved guidelines that educate patients in effective methods to prevent gout attacks and provide physicians with recommended therapies for long-term management of this painful disease are published in Arthritis Care & Research, a peer-reviewed journal of the American College of Rheumatology (ACR).

28 Sep 2012

Savient's KRYSTEXXA improves HRQOL and physical function in patients with RCG

Savient Pharmaceuticals, Inc. announced a new publication showing that adult patients with refractory chronic gout (RCG) treated bi-weekly with KRYSTEXXA- (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function.

3 Jul 2012

Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease

Savient Pharmaceuticals, Inc. announced that new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA (pegloticase) regardless of baseline CKD stage.

7 Jun 2012

Risk of gout flare-ups greatly increased by purine rich foods

Foods rich in purines, particularly those found in meat and seafood, quintuple the immediate risk of a gout flare-up, finds research published online in the Annals of the Rheumatic Diseases.

31 May 2012

Takeda enters definitive agreement to acquire URL Pharma

Takeda Pharmaceutical Company Limited and URL Pharma Inc. jointly announced that Takeda's wholly-owned subsidiary, Takeda America Holdings, Inc. and URL Pharma have entered into a definitive agreement to acquire URL Pharma – a privately-held pharmaceutical company headquartered in Philadelphia, Pennsylvania, for an upfront payment of $800 million and future performance-based contingent earn out payments.

12 Apr 2012

Colchicine, another weapon against cancer

Finding a drug that targets only the diseased cells in our body and is otherwise harmless to healthy tissue is a goal for cancer researchers. It's driven the work of Professor Laurence Patterson, Director of the Institute of Cancer Therapeutics at the University of Bradford, and his team of researchers.

2 Feb 2012

CMS assigns permanent J-code for Savient's KRYSTEXXA to treat RCG

Savient Pharmaceuticals, Inc. today announced that a product-specific billing code, or permanent J-code, for KRYSTEXXA (pegloticase) became available on January 1, 2012.

7 Jan 2012

Positive results from Metabolex arhalofenate plus febuxostat study on hyperuricemia, gout

Metabolex announced positive results from its clinical study of arhalofenate in combination with febuxostat. A key goal in the treatment of gout is to address the patient's underlying hyperuricemia by treatment with drugs that lower serum uric acid.

9 Dec 2011

$New data from Savient's KRYSTEXXA Phase III trial on refractory chronic gout$

New data from Savient's KRYSTEXXA Phase III trial on refractory chronic gout

Savient Pharmaceuticals, Inc. announced that data providing further clarity and context surrounding the risk for and management of infusion reactions that may occur with KRYSTEXXA (pegloticase) in the treatment of refractory chronic gout (RCG) patients will be presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in Chicago.

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

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

Crocus plant to provide a tumor killing “smart bomb”

According to the latest research, a drug derived from plant extracts could wipe out tumors in a single treatment with minimal side effects. Scientists have turned a chemical found in crocuses into a ‘smart bomb’ that targets cancerous tumors. The advantage is that healthy tissue is unharmed, reducing the odds of debilitating side effects. And unlike other side effect-free drugs, it is able to kill off more than one type of the disease, including breast, prostate, lung and bowel cancer. Potentially, all solid tumours could be vulnerable to drugs developed this way, meaning it could be used against all but blood cancers.

12 Sep 2011

Colchicine more effective than placebo for recurrent pericarditis

Colchicine, when given in addition to conventional therapy, was more effective than placebo in reducing the incidence of recurrence and the persistence of symptoms of pericarditis in a randomised controlled trial.

29 Aug 2011

Merck announces changes to high-dose simvastatin prescribing information in the U.S.

Merck, known as MSD outside the United States and Canada, today announced changes to the prescribing information in the United States for the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines.

9 Jun 2011

Two Novartis ACZ885 Phase III trial data in severe gouty arthritis to be presented at EULAR 2011

Novartis announced results of two pivotal Phase III trials in patients with severe gouty arthritis, showing that ACZ885 provided superior pain relief and reduced the risk of suffering new attacks by up to 68% compared to an injectable steroid used to treat gouty arthritis attacks.

25 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

GTx presents preclinical studies of GTx-758 and GTx-230 for treatment of cancer

GTx, Inc. announced the presentation of preclinical studies evaluating GTx-758, a selective estrogen receptor alpha agonist being developed for first line treatment of advanced prostate cancer, and GTx-230, a novel microtubule polymerization inhibitor.

15 Nov 2010

Colcrys safe for treating gout flares

Patients who experience gout flares can be treated safely with Colcrys (colchicine, USP), even in the presence of co-morbid conditions that often present physicians with treatment challenges, according to a new analysis presented here at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR).

9 Nov 2010