Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
 
Alba Therapeutics Corp.* ­ Oral larazotide acetate, a tight junction regulator Active celiac disease Enrolled the first European patient in an eight-week Phase IIb trial (11/12)
 
Centocor Inc. (unit of Johnson & Johnson) and Janssen-Cilag (Belgium) Ustekinumab Monoclonal antibody Plaque psoriasis Received a positive opinion from the CHMP (11/24)
 
CANCER
 
3SBio Inc. (SSRX) NuLeusin A second-generation interleukin-2 agent; genetically modified to improve biochemical properties over naturally occurring IL-2 Metastatic renal-cell carcinoma Filed for approval in China (11/10)
 
IDM Pharma Inc. (IDMI) Mepact Mifamurtide Nonmetastatic resectable osteosarcoma CHMP issued a positive opinion, recommending approval (11/18)
 
Oncolytics Biotech Inc. (Canada; ONCY; TSX:ONC) Reolysin Intravenous administration Advanced cancer Phase I and II UK trials appear to confirm preclinical evidence of synergy for Reolysin and platinum/taxane combinations (11/3)
 
CARDIOVASCULAR
 
AVI BioPharma Inc. (AVII) and Global Therapeutics* ­ A peptide-conjugated morpholino phosphorodiamate oligomer-based RNA therapeutic agent aimed at silencing C-MYC Restenosis Initiated the first trial of a drug-eluting stent in Germany (11/10)
 
DIABETES
 
Diamyd Medical AB (Sweden; SSE:DIAMB) Diamyd Diabetes vaccine Type I diabetes Six European countries have approved the initiation of a Phase III study (11/6)
 
INFECTION
 
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Zevtera Ceftobiprole; an anti-MRSA broad-spectrum cephalosporin Complicated skin and soft-tissue infections, including diabetic foot ulcers Obtained regulatory approval from Swissmedic (11/13)
 
MISCELLANEOUS
 
Progenics Pharmaceuticals Inc. (PGNX) Relistor (FDA-approved) Methylnaltrexone bromide Opioid-induced constipation Australia approved Relistor (11/17)
 
Sciele Pharma Inc. (SCRX) and Plethora Solutions Holdings plc (UK; LSE:PLE) PSD502 A proprietary formulation of lidocaine and prilocaine dispensed by a metered-dose aerosol Premature ejaculation European Phase III data showed it met its three co-primary end-points of intravaginal ejaculation latency time and index of premature ejaculation (11/7)
Notes:
* Privately held.
CMPH = 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.
LSE = London Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.