ADVENTRX Pharmaceuticals, Inc. and the 505(b)(2) New Drug Application (NDA) for ANX-530

There has certainly been a lot of attention paid to ADVENTRX Pharmaceuticals over the past few days so it comes as no surprise that we have had a lot of questions concerning this company’s use of a 505(b)(2) New Drug Application (NDA) for ANX-530. This NDA is different from a full NDA (the usual for [...]

Wyeth vs. GSK: A Vaccine Showdown?

Today Biohorizon will take its first look at two new vaccines that promise to make the prevention of pneumococcal disease far more interesting and complex. Both Wyeth and GSK have advanced emerging pneumococcal conjugate vaccine candidates to the filing stage in either the United States, European Union or both. In an effort to understand and [...]

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 [...]

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) [...]

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 [...]

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 [...]

Zenapax (daclizumab)

On March 15, 2004 Protein Design Labs, Inc. reported results from the initial clinical study of the humanized antibody daclizumab in patients with chronic, persistent asthma whose disease was not well controlled with high doses of inhaled corticosteroid therapy. This Phase II randomized, double-blind, placebo-controlled clinical trial was conducted at 24 centers in the United [...]

Daxas (roflumilast)

On March 12, 2004 Altana AG announced that it had presented strong data on its Chronic Obstructive Pulmonary Disease (COPD) drug roflumilast, also known as Daxas, at a German scientific meeting. Daxas, which is to be jointly marketed with Pfizer, has been filed for marketing approvals in Europe. Altana has said it hopes Pfizer will [...]