| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Biopartners GmbH* (Switzerland) | | Interferon beta-1a | Multiple sclerosis | Company is requesting a reassessment from the EMEA after receiving a negative opinion from the CHMP (2/20) |
| CANCER | ||||
| Ferring Pharmaceuticals SA* (Switzerland) | Firmagon | Degarelix; a gonadotropin-releasing hormone receptor antagonist | Advanced, hormone-dependent prostate cancer | Received European marketing approval (2/19) |
| Trion Pharma GmbH* (Germany) and Fresenius Biotech GmbH (Germany) | Removab | Catumaxomab; trifunctional antibody | Malignant ascites | CHMP recommended approval of Removab (2/19) |
| CARDIOVASCULAR | ||||
| Amgen Inc. (AMGN) | Nplate | Romiplostim | Splenectomized adult chronic immune thrombo-cytopenic purpura | European Commission granted marketing authorization (2/9) |
| CENTRAL NERVOUS SYSTEM | ||||
| ArGentis Pharmaceuticals LLC* | ARG201 | Native Type 1 bovine collagen | Diffuse systemic sclerosis | EMEA granted orphan drug designation (2/17) |
| DIABETES | ||||
| Oramed Pharmaceuticals Inc. (Israel; OTC BB:ORMP) | ORMD-0802 | Insulin suppository product | Diabetes | Concluded a proof-of-concept study in South Africa, showing it was well tolerated and had no adverse events (2/4) |
| INFECTION | ||||
| Basilea Pharmaceutica AG (Switzerland; SWX:BSLN) | Zevtera | Ceftobiprole | Complicated skin and skin structure infections | CHMP is initiating Good Clinical Practice inspections on a number of sites involved in the pivotal Phase III trials, delaying approval until at least the end of the year (2/24) |
| Emergent BioSolutions Inc. (NYSE:EBS) | BioThrax | Anthrax vaccine adsorbed | Anthrax | Approved in India (2/12) |
| Oncolys BioPharma Inc.* (Japan) | Festinavir | OBP-601; a nucleotide reverse transcriptase inhibitor | HIV | Started a Phase Ib study in France (2/4) |
| MISCELLANEOUS | ||||
| Emisphere Technologies Inc. (EMIS) | | Salmon calcitonin delivered orally using 5-CNAC | Bone breakdown | Data showed it is effective in reducing bone breakdown in an 81-subject study in Denmark (2/20) |
| Genzyme Corp. (GENZ) | Myozyme | Alglucosidase alfa | Pompe disease | CHMP issued a positive opinion on the company's variation to produce Myozyme at the 4,000 liter bioreactor scale (2/19) |
|
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. NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange. | ||||
