Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
AUTOIMMUNE | ||||
Abbott (NYSE:ABT) | Humira (FDA-approved) | Adalimumab; an inhibitor of tumor necrosis factor | Moderate-to-severe plaque psoriasis | Received marketing authorization from the European Commission for Humira (12/20) |
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) | Alitretinoin | Oral drug | Severe refractory chronic hand eczema | Filed its new drug submission with Health Canada (12/21) |
CANCER | ||||
Amgen Inc. (AMGN) | Vectibix | Panitumumab; a fully human anti-EGFR monoclonal antibody | EGFR-expressing metastatic colorectal cancer | European Commission approved Vectibix (12/6) |
Epeius Biotechnologies Corp.* | Rexin-G | Tumor-targeted cancer agent | Intractable cancers | Received approval in the Philippines (12/18) |
Genentech Inc. (NYSE:DNA), Biogen Idec Inc. (BIIB) and F. Hoffmann-La Roche Ltd. (Switzerland) | MabThera (FDA-approved) | Rituximab (Rituxan) | Follicular non-Hodgkin's lymphoma | CHMP issued a positive recommendation to extend the label for MabThera to include its use with any chemotherapy as a first-line treatment (12/14) |
Provectus Pharmaceuticals Inc. (OTC BB:PVCT) | PV-10 | Provecta | Stage III and Stage IV metastatic melanoma | Started recruiting patients in its Phase II trial in Australia (12/18) |
CENTRAL NERVOUS SYSTEM | ||||
Genzyme Corp. (GENZ) | Synvisc-One | Single-injection version of the marketed drug Synvisc (hylan G-F 20) | Pain associated with osteo-arthritis of the knee | Received a European CE Mark for Synvisc-One (12/19) |
Lexicon Pharmaceuticals Inc. (LEXG) | LX6171 | Inhibits a central nervous system membrane protein | Cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia and vascular dementia | Started a Phase IIa European trial (12/5) |
INFECTION | ||||
Napo Pharmaceuticals Inc. (LSE:NAPL) and Glenmark Pharmaceuticals Ltd. (India) | Crofelemer | Agent extracted from the rainforest plant Croton lechleri | Acute infectious diarrhea | Started a Phase II trial in India (12/6) |
MISCELLANEOUS | ||||
BioMimetic Therapeutics Inc. (BMTI) | GEM OS1 Bone Graft | Combines platelet derived growth factor with the bone matrix beta tricalcium phosphate | Foot and ankle fusions | A pivotal Canadian study showed 90% of patients gained benefit (12/14) |
Hospira Inc. (NYSE:HSP) | Retacrit | Epoetin zeta; a follow-on, or biosimilar, erythropoietin | Anemia associated with chronic renal failure and chemotherapy | European Commission has authorized it to market Retacrit (12/20) |
Neurochem International Ltd. (Switzerland; NRMX) | KIACTA | Eprodisate | Amyloid A amyloidosis | CHMP recommended refusal of the MAA, concluding that another study is needed to demonstrate effectiveness (12/14) |
Oculus Innovative Sciences Inc. (OCLS) and China Bao Tai (China) | Microcyn | Nonirritating small-molecule oxychlorine compound | Wound and burn care | China Bao completed two randomized, controlled trials (12/18) |
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. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange. |