Company* | Product | Description | Indication | Status |
CANCER |
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Amgen Inc. | Plenaxis | Prostate cancer drug | Prostate cancer | FDA issued a letter saying NDA data for the therapy is inadequate for approval (6/12) |
Antisoma | Pemtumomab | A yttrium-90 radiolabeled antibody formerly called Theragyn | Ovarian cancer | Company will increase the number of patients in its Phase III trial, per the FDA's request, extending the trial by 18 to 24 months (6/13**) |
Guilford Pharmaceuticals Inc. (GILD) | Gliadel Wafer | Polifeprosan 20 with carmustine implant | Malignant glioma | FDA accepted for review the sNDA seeking to expand the indication to include first-line therapy in newly diagnosed patients (6/6) |
ImClone | IMC-C225 | Used in combination with irinotecan; monoclonal antibody targeting and blocking epidermal growth factor receptor | Colorectal cancer | Company began filing a rolling BLA (6/28) |
MGI Pharma | Irofulven | Used in combination with Gemzar (gemcitabine hydrochloride) | Pancreatic cancer | FDA granted fast-track status for irofulven (6/28) |
Nycomed | EchoSeed | Uses ultrasound imaging for seed placement; a new generation of brachytherapy seed | Prostate cancer | FDA granted marketing clearance (6/4) |
Wilex AG | G250 | Unconjugated chimeric G250 Ig G monoclonal antibody | Renal cell carcinoma | FDA granted orphan drug status (6/1) |
CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer | Bosentan; endothelin receptor antagonist | Pulmonary arterial hypertension | FDA's Renal Drugs Advisory Committee will review the application for Tracleer on Aug. 9 (6/20) |
CytRx Corp. (CYTR) | Flocor | Purified poloxamer 188 | Acute chest syndrome associated with sickle cell disease | Flocor received fast-track designation from the FDA (6/14) |
United | Remodulin | Prostacyclin analogue | Pulmonary arterial hypertension | FDA's Cardiovascular & Renal Drugs Advisory Committee will meet in August concerning Remodulin (6/28) |
CENTRAL NERVOUS SYSTEM |
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Cellegy Pharmaceuticals Inc. (CLGY) | Anogesic | Nitroglycerin ointment | Pain associated with chronic anal fissures | Cellegy filed an NDA for Anogesic (6/26) |
Orphan Medical Inc. (ORPH) | Xyrem | Gammahydroxybutyrate | Narcolepsy | Peripheral and Central Nervous System Advisory Committee voted that Xyrem was an effective treatment (6/6) |
Protein Therapeutics Inc.* | ¿ | Oral human gammaglobulin | Juvenile rheumatoid arthritis | FDA granted orphan drug designation (6/14) |
INFECTION |
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Aviron Inc. (AVIR) | FluMist | Intranasal vaccine | Influenza | Vaccines & Related Biological Products Advisory Committee will meet July 26-27 (6/28) |
Visible Genetics Inc. (VGIN) | Trugene | Designed to genetically | To identify genetic mutations in HIV | FDA found the product meets the requirements for clearance, but not as a 501(k) device; the company is asking the FDA to classify the product as a class II device (6/28) |
MISCELLANEOUS |
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Biogen Inc. (BGEN) | Amevive | Novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells | Psoriasis | Company said it intends to file worldwide regulatory applications later this year (6/12) |
Genelabs Technologies Inc. (GNLB) | Aslera | Orally administered, highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone | Lupus erythematosus | Company received a not-approvable letter from the FDA (6/26) |
Lilly ICOS LLC (joint venture of ICOS Corp. [ICOS] and Eli Lilly and Co.) | Cialis | A PDE5 inhibitor | Erectile dysfunction | Company filed an NDA (6/28) |
Notes: |
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* Privately held; ** Denotes the date the item ran in BioWorld International. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX - Swiss Stock Exchange; |
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BLA = Biologics License Application; NDA = New Drug Application |
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