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Actavis files ANDA with FDA to market  Colchicine Tablets USP

Actavis files ANDA with FDA to market Colchicine Tablets USP

Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Colchicine Tablets USP, 0.6 mg. [More]
Takeda enters definitive agreement to acquire URL Pharma

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

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. [More]
Colcrys safe for treating gout flares

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). [More]

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). [More]
Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

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. [More]

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. [More]
Keryx Biopharmaceuticals commences Phase 3 registration program for Zerenex

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. [More]

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. [More]
Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

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

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. [More]

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). [More]
URL Pharma's Colcrys approved by FDA for prevention of gout flares

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. [More]

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). [More]