OSI Pharmaceuticals and Genentech’s Tarceva Non-Small Cell Lung Cancer Therapy

On November 18, 2004 OSI Pharmaceuticals and Genentech, Inc. announced that the FDA had approved their cancer therapeutic Tarceva™ (erlotinib). The oral tablet is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. The FDA’s approval of Tarceva was based on results [...]

Nabi Biopharmaceuticals Altastaph for the Prevention and Treatment of Staph. Aureus Infections

On Nov 17, 2004 Nabi Biopharmaceuticals released results from its Phase 2 clinical trial of Altastaph in premature or very low birth weight infants (infants weighing between 500 and 1500 grams). The company indicated that while the primary end-points of the study were met, an unexpectedly low rate of S. aureus infections in both the [...]

Abbott Labs ABT-874 for Treatment of Crohn’s Disease

On November 11, 2004 the results of an Abbott Labs Phase 2 Crohn’s disease clinical trial examining the safety and efficacy of ABT-874 were published in the New England Journal of Medicine. , ABT-874 is a monoclonal antibody designed to target interleukin-12 (IL-12). The authors concluded that treatment with ABT-874 may have caused clinical responses [...]

Nitromed’s BiDil Combination Therapy for Congestive Heart Failure

On November 8, 2004 Nitromed reported that the data from its Phase 3 A-HeFT trial would be published in the New England Journal of Medicine and presented at the American Heart Association’s Late Breaking Scientific Sessions. This randomized, placebo-controlled, double blind clinical trial enlisted 1050 African American patients with New York Heart Association class III [...]

MedImmune’s CAIV-T Influenza Vaccine

On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza vaccine trial had been completed. This pivotal trial is designed to compare the company’s nasally administered cold-adapted vaccine to the standard injectable vaccine in 8,492 children between 6 and 59 months of age. CAIV-T is refrigerator stable and is regarded by [...]

ID Biomedical’s FluInsure Influenza Vaccine

FluInsure™ On July 20 2004, ID Biomedical released preliminary data regarding FluInsure™ from its field efficacy study. Carried out during the 2003-2004 flu season at 28 sites throughout Canada, this study involved 1,349 healthy participants aged 18 to 64. A single dose of the nasally delivered, non-living vaccine had 67% efficacy (3/451 vs. 9/443 placebo) [...]

Vytorin for the Treatment of Hyperlipidemia

Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and [...]

Avanir Pharmaceuticals’ AVP 13358 for Asthma

On May 3, 2004 Avanir Pharmaceuticals released results of its Phase I clinical trial with AVP 13358 for asthma. The company reported that this trial, involving 54 healthy volunteers, was designed to demonstrate the safety, tolerability, and pharmacokinetic profile of a single oral administration of AVP 13358. The company indicated that AVP 13358 was well [...]

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 [...]

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