Company* (Country; Symbol) Product Description Indication Status (Date)
Targeted Genetics Corp. (TGEN) tgAAC94 Uses an adeno-associated virus vector to deliver the gene encoding a soluble form of the receptor for TNF-alpha Inflammatory arthritis FDA placed a hold on the development program following a serious adverse event in one subject (7/25)
GPC Biotech AG (Germany; GPCB), Pharmion Corp. (PHRM) and Spectrum Pharmaceuticals Inc. (SPPI) Orplatna Satraplatin; oral platinum compound Hormone- refractory prostate cancer The Oncology Drugs Advisory Committee voted 12-0 to recommend that the agency wait for the overall survival results, expected the end of this year (7/24); company withdrew the NDA (7/30)
Spectrum Pharmaceuticals Inc. (SPPI) ISO-Vorin Levofolinic acid, LFA; the pure active isomer of calcium lecuovorin Osteogenic sarcoma Completed the filing of an amendment to the NDA for ISO-Vorin; it addresses questions regarding the chemistry manufacturing and control section of the filing (7/2)
Lev Pharmaceuticals Inc. (OTC BB:LEVP) Cinryze A C1 inhibitor Hereditary angioedema Lev submitted a BLA for its C1 inhibitor (7/31)
Neurochem Inc. (NRMX) Alzhemed Tramiprosate Alzheimer's disease FDA granted fast-track status (7/24)
ProEthic Pharmaceuticals Inc.* PRO-513 Uses the company's Dynamic Buffering Technology to enhance the absorption of the active ingredient diclofenac potassium Migraines Submitted an NDA (7/2)
Shire plc (UK) Vyvanse Lisdexamfetamine dimesylate Attention deficit hyper-activity disorder in adults Submitted an sNDA (7/2)
ImmunoMod LLC* Agent for protecting beta cell function in early stage diabetic youth Type I diabetes Received an FDA Orphan Drug Grant award and is beginning its first clinical trial (7/25)
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Ceftobiprole Broad-spectrum, anti MRSA cephalosporin antibiotic Complicated skin and skin structure infections U.S. regulatory authorities accepted the NDA (7/18)
BioMarin Pharmaceutical Inc. (BMRN) Kuvan Sapropterin dihydro-chloride Phenylketonuria Received priority review status from the FDA for its NDA for Kuvan (7/26)
Hoffmann-La Roche Inc. Tamiflu (FDA-approved) Oseltamivir phosphate capsules Influenza FDA approved an sNDA to market Tamiflu in 30-mg and 45-mg doses (7/3)
Idenix Pharmaceuticals Inc. (IDIX) NM283 Valopicitabine; nucleoside inhibitor Hepatitis C virus FDA ordered a clinical hold of the Phase II drug due to gastrointestinal side effects (7/13)
Tibotec Pharmaceuticals Ltd. (Ireland; unit of Johnson & Johnson) TMC125 Etravirine HIV Submitted an NDA (7/18)
Allergy Therapeutics plc (UK; PK:AGYTF) Pollinex Quattro Hay fever allergy vaccine Hay fever FDA put the U.S. trial on hold after one subject suffered an adverse reaction; the company will have to conduct a new trial (7/24)
Humanetics Corp.* BIO 300 A small, single molecular agent Acute radiation syndrome FDA granted orphan drug designation (7/20)
MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) Aloxi Palonosetron hydrochloride injection To prevent postoperative nausea and vomiting FDA accepted for filing the sNDA (7/9)
Neurochem Inc. (NRMX) Kiacta Eprodisate AA amyloidosis FDA issued a second approvable letter, requesting a new efficacy trial and further pharmacokinetic studies (7/18)
QLT Inc. (QLTI) Aczone (FDA-approved) Dapsone gel formulated with SMP technology Acne FDA accepted for filing and review its labeling supplement for Aczone, requesting the removal of the glucose-6-phosphate dehydrogenase screening and blood monitoring requirements from its current label (7/23)
Vivus Inc. (VVUS) Evamist A metered-dose trans-dermal estradiol spray Moderate to severe vaso-motor symptoms due to menopause Won FDA approval (7/30)
Wyeth Pharmaceuticals Pristiq Desvenlafaxine; a serotonin-norepinephrine reuptake inhibitor Moderate to severe vaso-motor symptoms FDA issued an approvable letter (7/24)

* Privately held.
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.
OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange