Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Genelabs | Prestara | Prasterone; the synthetic equivalent of dehydroepiandrosterone | Lupus | FDA granted an approvable letter (8/30) |
CANCER | ||||
FeRx Inc.* | MTC- | Doxorubicin released through Magnetic Target Carriers, microparticles composed of elemental iron and activated carbon | Primary liver cancer | Company was granted fast-track status for MTC-DOX, which is in a Phase II/III trial (8/26) |
CENTRAL NERVOUS SYSTEM |
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Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc. (NYSE:FRX) | Memantine | Orally available neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N-methyl D-aspartate receptor on cell membranes | Alzheimer's disease | Companies filed an NDA (8/1) |
Proneuron Biotechnologies Inc.* (Israel) | - | Experimental autologous | Spinal cord | Company received FDA permission to continue accruing patients in a trial following a report on interim clinical results and manufacturing and quality control procedures (8/13) |
INFECTION | ||||
Gilead Sciences | Adefovir dipivoxil | Nucleotide analogue that works by blocking the hepatitis B virus DNA polymerase, an enzyme responsible for replicating the virus | Chronic hepatitis B | FDA panel unanimously recommended approval of adefovir dipivoxil (8/6) |
MedImmune Inc. | FluMist | Nasal influenza vaccine | Influenza | Company gave the FDA the information it sought in a complete review letter (8/27) |
MISCELLANEOUS |
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Columbia Laboratories Inc. (AMEX:COB) | - | Testosterone buccal bio-adhesive product, a controlled- and sustained-release product containing 30 mg of testosterone | Testosterone deficiency | Company submitted an NDA to the FDA after Phase III data had positive results (8/9) |
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Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange | ||||
NDA = New Drug Application | ||||
