Company* (Country;Symbol)ProductDescriptionIndicationStatus (Date)
AUTOIMMUNE
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN)Tysabri (FDA-approved)NatalizumabCrohn's diseaseA joint FDA advisory panel gave a positive recommendation for approval (8/1)
CANCER
Advanced Life Sciences Holdings Inc. (ADLS)ALS-357Topical treatment that induces apoptosisMetastatic melanomaFDA granted orphan drug status (8/28)
Adventrx Pharmaceuticals Inc. (AMEX:ANX)ANX-510CoFactor injectionMetastatic colorectal cancerFDA granted fast track designation for the product (8/16)
Cephalon Inc. (CEPH)TreandaBendamustine HClChronic lymphocytic leukemiaFDA granted orphan drug designation (8/30)
GammaCan International Inc. (Israel; OTC BB:GCAN)VitiGamAn intravenous IgG-based immunotherapyStage IIb to Stage IV meta-static melanomaVitiGam received orphan drug designation (8/7)
Genentech Inc. (NYSE:DNA)Avastin (FDA-approved)BevacizumabMetastatic breast cancerResubmitted an sBLA seeking approval of Avastin, in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy (8/24)
IDM Pharma Inc. (IDMI)JunovanMifamurtideOsteosarcomaFDA issued a not-approvable letter asking for more clinical trial data (8/27)
Indevus Pharmaceuticals Inc. (IDEV)Valstar (FDA-approved in 1998; withdrawn 2002)ValrubicinBladder cancerFDA issued an approvable letter; the product was taken off the market in 2002 due to impurities (8/17)
Innovive PharmaceuticalInc. (OTC BB:IVPH)TamibaroteneOral synthetic retinoidAcute promyelo-cytic leukemiaCompany and FDA agreed on an SPA for a Phase II trial (8/3)
MethylGene Inc. (Canada; TSX:MYG) and Pharmion Corp. (PHRM)MGCD0103Histone deacetylase inhibitorHodgkin's lymphomaFDA granted orphan status (8/21)
CARDIOVASCULAR
CV Therapeutics Inc. (CVTX)Ranexa (FDA-approved)Ranolazine extended-release tabletsAnginaFDA approved the 1,000-mg tablet (8/14)
Encysive Pharmaceuticals Inc. (ENCY)ThelinSitaxsentan sodiumPulmonary arterial hypertensionFiled with the FDA a request for formal dispute resolution to contest the third approvable letter for Thelin (8/7)
LifeCycle Pharma A/S (Denmark; CSE:LCP) and Sciele Pharma Inc.Fenofibrate120-mg and 40-mg dosage strengths; it uses LifeCycles Melt-dose technologyHyperlipidemia and hypertriglyc-eridemiaFDA approved the formulation(8/13)
Omrix Bio-pharmaceutical Inc. (OMRI)EvithromHuman thrombin product; derived from human plasmaFor use in general surgery procedures to control minor bleedingFDA approved the product (8/28)
The Medicines Co. (MDCO)Angiomax (FDA-approved)BivalirudinAcute coronary syndromesSubmitted an sNDA (8/7)
CENTRAL NERVOUS SYSTEM
Anesiva Inc. (ANSV)ZingoLidocaine product that uses a needle-free, disposable intradermal injection system that delivers 0.5 mg of powdered sterile lidocaine into the skin via compressed heliumPainFDA approved the product for use in hospitalized children ages 3 to 18 (8/17)
Janssen LP (unit of Johnson & Johnson)Risperdal (FDA-approved)RisperidoneSchizophreniaFDA approved it for adolescents ages 13 to 17 (8/22)
Jazz Pharmaceuticals Inc. (JAZZ) and Solvay Pharmaceuticals Inc. Luvox CRFluvoxamine maleate extended-release capsulesObsessive compulsive disorder and social anxiety disorderFDA accepted for review the submission of the complete response to an approvable letter (8/3)
Neurocrine Biosciences Inc. (NBIX)Indiplon5-mg and 10-mg capsules of an immediate-release versionInsomniaFDA accepted its resubmitted NDA (8/22)
Pozen Inc. (POZN)TreximaCombination of 85 mg of sumatriptan with 500 mg of naproxen sodiumMigrainePozen received a second approvable letter from the FDA; the agency is concerned over a preclinical genotoxicity study (8/2)
INFECTION
Lux Biosciences Inc.*LX211A next-generation calcineurin inhibitorUveitisFDA granted fast-track designation (8/7)
Monogram Biosciences Inc. (MGRM)TrofileDiagnostic; co-receptor tropism assayHIVMonogram launched the product, which must be used with Pfizer Inc.'s Selzentry (maraviroc) tablets for HIV; it received FDA approval recently (8/6)
MISCELLANEOUS
Abraxis BioScience Inc. (ABBI)OxytocinA new dose injectionTo initiate or improve uterine contractions in labor-related issuesReceived FDA approval of the sNDA on a new dose of Oxytocin injection (8/7)
Adolor Corp. (ADLR)EnteregA peripherally acting muopioid receptor antago-nist; alvimopanPostoperative ileus FDA accepted the complete response to an approvable letter (8/28)
Axcan Pharma Inc. (Canada; AXCA)Ultrase (FDA-approved)Pancrelipase capsulesExocrine pancreatic insufficiencySubmitted a complete NDA (8/2)
Auxilium Pharmaceuticals Inc. (AUXL)XiaflexClostridial collagenase for injectionDupuytren's contracture Was cleared from the FDA to resume its Phase III trials for Xiaflex (8/16)
Indevus Pharmaceuticals Inc. (IDEV)Sanctura XR (FDA-approved)Trospium chloride extended-release capsulesOveractive bladderFDA approved Sanctura XR (8/6)
Indevus Pharmaceuticals Inc. (IDEV)NebidoAn injectable three-month formulation of testerone undecanoatePrimary and secondary hypogonadismFiled with the FDA seeking approval (8/28)
Oragenics Inc. (AMEX:ONI)SMaRT Replacement TherapyTopical treatment based on a genetically modified strain of Streptococcus mutansTo prevent dental cavitiesFDA placed a clinical hold on a proposed Phase Ib safety study (8/13)
Regeneron Pharmaceuticals Inc. (REGN)RilonaceptInterleukin-1 TrapCryopyrin-associated periodic syndromesFDA accepted for filing and granted priority review status to the BLA (8/8)
Tercica Inc. (TRCA) and Ipsen SA (France; PARIS:IPN)Somatuline DepotA somatostatin analog packaged as a pre-filled syringeAcromegalyFDA approved the product (8/31)
Tikvah Therapeutics Inc.*Sodium phenylbutyrateA histone deacetylase inhibitorSpinal muscular dystrophyFDA granted orphan drug status (8/20)

Notes:
* 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.

AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange

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