Drug
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)... Read more of this article
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... Read more of this article
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... Read more of this article
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Vaccine
Wyeth vs. GSK: A Vaccine Showdown?
Today Biohorizon will take its first look at two new vaccines that promise to make...
MedImmune’s CAIV-T Influenza Vaccine
On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza...
ID Biomedical’s FluInsure Influenza Vaccine
FluInsure™ On July 20 2004, ID Biomedical released preliminary data regarding FluInsure™...
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Diagnostic Test
Matritech’s NMP179 for Detection of Cervical Cancer
On May 10, 2004 Matritech announced the beginning of clinical testing of 10,000 samples...
OraQuick Rapid HIV Antibody Test
On March 26, 2004 OraSure Technologies, Inc. announced that it has received U.S....
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