Company* | Product | Description | Indication | Status |
(Symbol) | (Date) |
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CANCER |
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Battelle | Doxorubicin | Inhalation | Pulmonary brochioloalveolar carcinoma | FDA granted the therapy fast-track status (5/22) |
Genaera Corp. (GENR) | Squalamine | Combination therapy with standard chemotherapy of carboplatin and paclitaxel | Ovarian cancer | FDA gave orphan drug status to squalamine (5/30) |
Genentech Inc. (NYSE:DNA) | Rituxan | Rituximab; genetically engineered chimeric | Non-Hodgkin's lymphoma | FDA approved a supplemental BLA to allow retreatment with Rituxan after a prior course of therapy, doubling of infusions and bulky disease, or tumors greater than 10 centimeters, for patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma (5/14) |
IDEC Pharmaceuticals Corp. (IDPH) | Zevalin | Mouse monoclonal antibody targeted against the CD20 antigen and conjugated to a yttrium-90 radioisotope; administered with Rituxan | Non-Hodgkin's lymphoma | FDA requested additional data in a review letter concerning the BLA (5/10) |
ILEX Oncology | Campath | Alemtuzumab; humanized monoclonal antibody | Leukemia | FDA approved Campath (5/8) |
CARDIOVASCULAR |
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Scios Inc. (SCIO) | Natrecor | Nesiritide; recombinant form of B-type natriuretic peptide | Acute congestive heart failure | The Cardiovascular and Renal Drugs Advisory Committee recommended approval of Natrecor (5/25) |
INFECTION |
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Gilead Sciences Inc. (GILD) | Tenofovir DF | Reverse transcriptase inhibitor; tenofovir disoproxil fumarate | HIV | Company submitted an NDA (5/1) |
MISCELLANEOUS |
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Gliatech Inc. | Adcon-L | Gel to inhibit postsurgical scarring | Postsurgical scarring | FDA issued a warning letter to a study site for failure to notify the review board within three days regarding an unanticipated adverse event, a cerebrospinal fluid leak, or changes to the protocol (5/11) |
Ortec International Inc. (ORTC) | Composite Cultured Skin | Cryopreserved (frozen) version of CCS | Burn wounds | FDA said the product will be reviewed by the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on July 17 (5/14) |
Sepracor Inc. (SEPR) | Soltara | Norastemizole 30 mg and 15 mg capsules | Allergic rhinitis | FDA accepted the NDA for Soltara (5/9) |
Notes: |
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* Denotes privately held company. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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NYSE = New York Stock Exchange |
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BLA = Biologics License Application; NDA = New Drug Application |
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