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Positive results from Ardea's RDEA594 combination study with febuxostat or allopurinol for gout

Ardea Biosciences, Inc. announced positive results from two clinical studies of RDEA594 in combination with currently marketed drugs for the treatment of gout patients, febuxostat (Uloric®) and allopurinol.

8 Nov 2010

60 Plus applauds FDA decision to remove unapproved colchicine products

James L. Martin, chairman of the 60 Plus Association, a seniors advocacy group, applauded the Food and Drug Administration's (FDA) decision to remove unapproved colchicine products from the market, and called on drug manufacturers, distributors and pharmacies to help the FDA protect patients from unapproved drugs.

19 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

$Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy$

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA™ (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

15 Sep 2010

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 Aug 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

Nuon study confirms potential utility of tranilast as uricosuric agent

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that results from clinical and preclinical studies demonstrating the ability of tranilast to reduce serum uric acid levels and monosodium urate crystal-induced inflammation - two important risk factors for gout - were presented at The European League Against Rheumatism (EULAR) 2010 Annual European Congress of Rheumatology in Rome, Italy, June 16-19, 2010.

22 Jun 2010

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Regeneron Pharmaceuticals, Inc. announced that a Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that ARCALYST (rilonacept), also known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

9 Jun 2010

Oramed reports Phase 2b non-FDA clinical trial results of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc., a developer of alternative drug delivery systems, reported today results for the recently completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.

7 May 2010

Keryx Biopharmaceuticals commences Phase 3 registration program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today the initiation of its short-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

6 May 2010

Mount Sinai Medical Center's overall revenue growth for 2009 increased by 5%

Demonstrating the fortitude to address a challenging healthcare environment, president and C.E.O. Steven D. Sonenreich has led Mount Sinai Medical Center to financial stability and successfully reinforced its image as a healthcare leader. The most recent audit posted on March 26 reports nearly $14 million in profit for 2009.

1 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

Ardea Biosciences, Inc. announced positive, preliminary, top-line results from its Phase 2b monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. In this 28-day, randomized, double-blind, placebo-controlled, dose-escalation study, 123 gout patients with hyperuricemia (serum urate levels greater than or equal to 8 mg/dL) received 200 mg once-daily (qd) RDEA594, 400 mg qd RDEA594, 600 mg qd RDEA594 or matching placebo.

1 Apr 2010

Report provides comprehensive insight into how physicians classify and treat patients with gout

BioTrends Research Group, Inc. is pleased to announce the availability of its TreatmentTrends®: Gout and Hyperuricemia publication. The report is based on responses to online surveys completed by 120 Rheumatologists and 57 Primary Care Physicians in the US who are managing a high number of patients with gout.

3 Mar 2010

Colcrys Patient Assistance Program introduced by URL Pharma

URL Pharma, Inc. announced the launch of the Colcrys® (colchicine, USP) Patient Assistance Program, an initiative that will allow patients with limited means to save on Colcrys prescriptions. This program reflects URL Pharma's ongoing commitment to helping ensure that all patients who rely on the company's medications are able to access them, regardless of economic status. Colcrys is indicated for the prevention and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF).

24 Dec 2009

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC- (febuxostat) treatment.

20 Oct 2009

URL Pharma's Colcrys approved by FDA for prevention of gout flares

URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

19 Oct 2009

Colchicine approved for acute gout, Mediterranean fever

The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication's active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

30 Jul 2009

Colchicine News and Research

Positive results from Ardea's RDEA594 combination study with febuxostat or allopurinol for gout

60 Plus applauds FDA decision to remove unapproved colchicine products

FDA takes action against unapproved single-ingredient oral colchicine

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Nuon study confirms potential utility of tranilast as uricosuric agent

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Oramed reports Phase 2b non-FDA clinical trial results of ORMD-0801 oral insulin capsule

Keryx Biopharmaceuticals commences Phase 3 registration program for Zerenex

Mount Sinai Medical Center's overall revenue growth for 2009 increased by 5%

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Positive results from Ardea Biosciences' Phase 2b study of RDEA594 for hyperuricemia and gout

Report provides comprehensive insight into how physicians classify and treat patients with gout

Colcrys Patient Assistance Program introduced by URL Pharma

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

URL Pharma's Colcrys approved by FDA for prevention of gout flares

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Colchicine approved for acute gout, Mediterranean fever

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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