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. |