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.