Amylin, Lilly, and Alkermes Await FDA Decision on Byetta for Diabetes

On February 25th, 2010, Amylin, Lilly, and Alkermes announced in a press release that the FDA had set March 12th 2010 as the Prescription Drug User Fee Act (PDUFA) action date for Byetta’s long acting formulation –  exenatide once weekly.   Our readers will recall that Byetta is used by type 2 diabetics for glycemic (blood glucose) control and [...]

Oral Therapies for Multiple Sclerosis – Fingolimod (FTY 720) and Cladribine: How Close are Novartis and Merck KGaA to FDA Approval?

These are interesting days for the first oral therapies targeting multiple sclerosis (cladribine and  fingolimod or FTY720) indeed, with both positive and negative events making news over the last several weeks.  On November 30th 2009,  Reuters reported that the FDA had issued Merck KGaA a ‘refuse to file’ letter, which in effect is the FDA’s way [...]

MannKind’s AFREZZA vs. Pfizer’s Exubera: Will Inhaled Insulin Be Different This Time?

With an FDA decision pending on Mannkind Corporation’s AFREZZA (TM)  (insulin human (rDNA origin) Inhalation Powder – formerly named AFRESA ) and the recent failure of the first inhaled insulin to receive FDA approval, we thought it would be helpful to provide an analytical approach to this emerging health technology.
For those who are unfamiliar with [...]

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 [...]

Pneumococcal Disease In Children

In follow up to our discussion of pneumococcal conjugate vaccines yesterday, we thought readers would benefit from a brief review of the diseases that these vaccines are designed to prevent.
Clinical Presentations
Streptococcus pneumoniae causes acute bacterial infections. Also referred to as the pneumococcus bacteria, it was first isolated by Pasteur in 1881. Prior [...]

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 [...]

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 [...]

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