Amgen’s Enbrel for Psoriasis

On April 30, 2004 Amgen Inc. announced that its biological therapy Enbrel® (etanercept) had received approval from the FDA. The drug is approved for the treatment of psoriasis in adult patients who are candidates for systemic therapy and who suffer from chronic moderate-to-severe plaque psoriasis. This most recent approval adds to Enbrel’s previously approved indications [...]

Iressa (Gefitinib) for Non Small Cell Lung Cancer

On April 29, 2004 The New England Journal of Medicine and Science magazine published early release articles online concerning Iressa. Both of these studies identified a sub-group of patients with non small cell lung cancer (NSCLC) and specific mutations in the EGFR gene. These articles concluded that screening for these mutations might identify patients who [...]

Cordis Carotid System for Carotid Artery Disease

On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to Cordis, [...]

CV Therapeutics’ Ranexa for Chronic Angina

On April 20, 2004 CV Therapeutics released data from its Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial. The company reported that patients with chronic angina taking Ranexa™ (ranolazine) had a statistically significant increase in symptom-limited exercise duration at trough drug concentrations. The MARISA clinical trial is a double blind, placebo controlled study involving [...]

VaxGen’s rPA102 Recombinant Anthrax Vaccine

On April 15, 2004 VaxGen, Inc. announced that it had started the Phase II clinical testing of rPA102, its recombinant anthrax vaccine. VaxGen indicated that this 13-month trial is one of two studies under a $80.3 million agreement with the NIH’s National Institute of Allergy and Infectious diseases. The purpose of this study, involving 480 [...]

DAC GLP-1 for Type II Diabetes

On April 12, 2004 ConjuChem Inc. announced interim Phase II results for DAC™: GLP-1. The company released results for patients who had received the first 28 days of therapy of the planned 3 month trial. Based on approximately 80 patients to date, ConjuChem reported a statistically significant reduction in Hgb A1C and glucose normalization or [...]

Humira (adalimumab) for rheumatoid arthritis

In December of 2002, Abbott Laboratories received FDA approval for Humira®, its human monoclonal antibody for the treatment of adults with moderate to severe rheumatoid arthritis. At that time, Biohorizon placed Humira in its High Impact Technology category and recommended preliminary assessment activites. In an April 2004 company news release, Abbott announced that worldwide sales [...]

Torcetrapib for increasing HDL cholesterol

On April 7, 2004 Pfizer announced preliminary results of a Phase I trial with torcetrapib, its experimental therapy for increasing HDL cholesterol. A study was published in the April 8, 2004 issue of the New England Journal of Medicine, involving 19 patients. The results showed that torcetrapib significantly increased the level of high-density lipoprotein (HDL) [...]

Surveillance Summary Apr 3 – Apr 9, 2004

Our emerging health technology surveillance system experienced light activity throughout Week 15 of 2004 with a total of 12 technologies updated. Of these, 5 were new detects and 7 were already present in the Biohorizon database. The average impact score was 36, down 6 from last week. A fairly narrow spectrum of target diseases was [...]

Preos osteoporosis drug

On March 30, 2004 NPS Pharmaceuticals Inc. said that its Phase III osteoporosis drug, Preos, significantly reduced spinal fractures or worsening of fractures in a study of 2, 600 postmenopausal women. The 18-month study on Preos involved postmenopausal women with mild to moderate osteoporosis. 81% of participants had no previous history of vertebral fracture. The [...]

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