Company* (Country; Symbol)ProductDescriptionIndicationStatus (Date)

Abbott (NYSE:ABT)Humira (FDA-approved)AdalimumabModerate to severe plaque psoriasisCHMP recommended approval (11/16)
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN)Tysabri (FDA-approved)NatalizumabCrohn's diseaseCHMP recommended rejecting marketing authorization (11/16)
Genmab A/S (Denmark; CSE:GEN)OfatumumabBinds to the B-cell receptor CD20Rhuematoid arthritisStarted a Phase III trial in Europe (11/20)
UCB SA (Belgium; BR:UCB)CimziaCertolizumab pegolCrohn's diseaseCHMP issued a negative opinion on the MAA in the European Union (11/16)
Aeterna Zentaris Inc. (Canada; AEZS)PerifosineA first-in-class, oral signal transduction inhibitorNon-small-cell lung cancerCompleted enrollment in a European multicenter Phase II trial (11/14)
Celgene International Sarl (Switzerland; CELG)Revlimid (FDA-approved)LenalidomideMultiple myelomaThe Australian Drug Evaluation Committee recommended approval of Revlimid in combination with dexamethasone in patients whose cancers have progressed after one therapy (11/12)
Celgene International Sarl (Switzerland; CELG)Revlimid (FDA-approved)LenalidomideChronic lymphocytic leukemiaEuropean Commission granted orphan drug status (11/30)
Introgen Therapeutics Inc. (INGN)AdvexinA targeted p53 tumor suppressor therapyLi-Fraumeni syndrome cancersSubmitted an MAA in Europe (11/13); regulatory authorities accepted the MAA (11/27)
Peregrine Pharmaceuticals Inc. (PPHM)BavituximabA monoclonal antibody designed to target and bind to phophatidylserineMetastatic breast cancerA Phase II protocol of the drug in combination with the chemotherapy drug docetaxel was approved in Georgia (11/16)
Wyeth PharmaceuticalsToriselTemsirolimus; an mTOR (mammalian target of rapamycin kinase) inhibitorAdvanced renal-cell carcinomaEuropean Commission approved Torisel (11/26)
The Medicines Co. (MDCO)Angiox (FDA-approved)BivalirudinAdult coronary syndromeCHMP adopted a positive opinion to extend the indication to adult patients planned for urgent or early intervention, specifically patients with unstable angina or non-ST segment elevation myocardial infarction (11/19)
Neurochem Inc. (Canada; NRMX)AlzhemedTramiprosateAlzheimer's diseaseDiscontinued its European Phase III trial and said it instead plans to commercialize the product as a branded nutraceutical (11/8)
Generex Biotechnology Corp. (GNBT)Oral-lynOral insulin spray, a non-injectable buccal insulinDiabetesReceived approval in India (11/1)
Avant Immunotherapeutics Inc. (AVAN) and GlaxoSmithKline plc (UK)RotarixRotavirus vaccineRotavirusAvant said new data from a European trial showed the vaccine is effective against the five most commonly circulating rotavirus types (11/26)
Crucell NV (the Netherlands; CRXL)Rabies monoclonal antibody cocktailRabiesAn Indian Phase Ib study indicated the treatment is well tolerated (11/30)
Samaritan Pharmaceuticals Inc. (AMEX:LIV)AmphocilAn injection; a lipid form of amphotericin BInvasive aspergillosis The company's subsidiary received notification from the Cyprus Ministry of Health that its MAA was approved in Cyprus (11/9)
ViroPharma Inc. (VPHM)CamviaMaribavir; a benzimidazole ribosideTo prevent cytomegalo-virusGranted orphan drug status in Europe (11/12)
BioMarin Pharmaceutical Inc. (BMRN) and Merck Serono (Germany) Sapropterin dihydrochlorideOral treatmentHyperphenyl-alaninemiaSubmitted an MAA (11/8)
Biopure Corp. (BPUR)HemopureA purified hemoglobin blood substitute for surgery patientsAcutely anemic orthopedic surgery patientsSubmitted a complete response to questions from the UK Commission on Human Medicines regarding potential marketing approval (11/8)
Cangene Corp. (Canada; TSX:CNJ)WinRho SDFRho(D) immune globulin (human); a hyperimmune antibody preparationHemolytic disease in newborns and immune thrombocytopenic purpuraHealth Canada approved the liquid formulation (11/29)
Novogen Ltd. (Australia; NVGN)NV-52A synthetic flavonoidInflammatory bowel diseasePhase Ia and Phase Ib data showed it may be useful for maintaining remission (11/13)
StemCells Inc. (STEM) HuCNS-SC cellsPurified human neural stem cellsBatten diseaseOne patient has completed the Phase I trial; of the five patients transplanted so far, there have been no safety issues (11/30)
Sucampo Pharma Ltd. (Japan; SCMP)Amitiza (FDA-approved)LubiprostoneAdult chronic constipationStarted a Phase IIb study in Japan (11/29)

* Privately held.
CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.
AMEX = American Stock Exchange; BR = Brussels Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; TSX = Toronto Stock Exchange.

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