Oncology Update: regorafenib improves survival in metastatic colorectal cancer (mCRC)

According to a press release issued by Onyx Pharmaceuticals, Inc. on October 25, 2011 a Phase 3 trial with regorafenib in metastatic colorectal cancer (mCRC) patients  being conducted by Bayer HealthCare Pharmaceuticals met its primary endpoint of improved overall survival.   Apparently, this trial’s independent Data Monitoring Committee conducted a pre-planned interim analysis and recommended that the study be unblinded [...]

Oncology Update: ADCETRIS(TM) Brentuximab Vedotin

We have completed our preliminary assessment of the FDA approved oncology drug ADCETRIS (TM) Brentuximab Vedotin using BioHorizon’s proprietary assessment methodology and have designated this oncology therapeutic agent as High Impact.  Given the observed treatment effect in pivotal clinical trials we see potential for rapid uptake by oncologists responsible for treating the indicated patient populations.  As with all [...]

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 [...]

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 [...]

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 to [...]

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 [...]

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