| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| CANCER | ||||
| Abraxis BioScience Inc. (ABII) | Abraxane (FDA-approved) | Powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel | Metastatic breast cancer | European Commission granted marketing approval (1/22) |
| Celgene International Sarl (Switzerland; CELG) | Revlimid (FDA-approved) | Lenalidomide | Transfusion-dependent anemia due to myelodysplastic syndromes | CHMP issued a negative opinion, saying the safety data was not sufficient (1/24) |
| Cephalon Inc. (CEPH) | Effentora | Fentanyl buccal tablet pain medication | Breakthrough pain in adult cancer patients | CHMP issued a positive opinion (1/24) |
| Peregrine Pharmaceuticals Inc. (PPHM) | Bavituximab | A monoclonal antibody that binds to phosphat-idylserine | Advanced breast cancer | Started screening patients for a clinical trial evaluating safety and efficacy; it is being conducted in the Republic of Georgia (1/29) |
| Pharmion Corp. (PHRM) | Thalomid | Thalidomide | Multiple myeloma | CHMP issued a positive opinion (1/24) |
| Pharmion Corp. (PHRM) | Vidaza | Azacitidine for injection | Myelodysplastic syndrome | Submitted an MAA with the EMEA (1/14) |
| Tigris Pharmaceuticals Inc.* | AFP-464 | Aminoflavone prodrug | Cancer | Started a Phase I trial in Europe (1/30) |
| CARDIOVASCULAR | ||||
| Alexion Pharmaceuticals Inc. (ALXN) | Soliris | Eculizumab | Paroxysmal nocturnal hemoglobinuria | Started dosing patients in a study in Japan (1/7) |
| M'S Sciences Corp.* | SA4503 | A selective agonist of the sigma-1 receptor | Stroke | Started a Phase II study in Europe (1/30) |
| The Medicines Co. (MDCO) | Angiox | Bivalirudin | Acute coronary syndromes | Received European Commission approval for an expanded use of Angiox in adult patients, specifically those with unstable angina or non-ST segment elevation myocardial infarction (1/29) |
| INFECTION | ||||
| BioAlliance Pharma SA (France; PARIS:BIO) | Loramyc | Bioadhesive buccal tablet containing the antifungal agent miconazole | Oropharyngeal candidiasis | Received marketing authorization in the UK and Denmark (1/9) |
| Emergent BioSolutions Inc. (NYSE:EBS) | Drinkable typhoid vaccine | Typhoid | Phase II data showed an immune response in 97% of 151 Vietnamese children (1/8) | |
| MISCELLANEOUS | ||||
| Kamada (Israel; TASE:KMDA) | Alpha-1 Antitrypsin | Aerosolized version that uses an eFlow Electronic Nebulizer | Lung diseases | Concluded Phase I testing (1/15) |
| MolMed SpA* (Italy) | TK therapy | Transplanted donor T cells | Graft-vs.-host disease | MolMed is starting a Phase III trial in Italy (1/30**) |
| Nicox SA (France; FSE:NXO) and Pfizer Inc. | PF-03187207 | A nitric oxide-donating prostaglandin F2-alpha analogue | Glaucoma | Began a dose-ranging Phase II trial in Japan (1/3) |
| Pharmaxis Ltd. (Australia; PXSL) | Aridol | Mannitol formulation delivered via an inhalation device | Asthma | Korean regulatory agency granted marketing approval (1/17) |
|
Notes: * 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.FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; SSE = Stockholm Stock Exchange; TASE = Tel Aviv Stock Exchange. | ||||
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