Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira |
Adalimumab |
Ankylosing spondylitis |
Health Canada granted marketing approval (11/6) |
KaloBios |
KB002 |
Engineered human monoclonal antibody that targets and neutralizes GM-CSF, the granulocyte macrophage colony- stimulating factor |
Rheumatoid arthritis |
Started Phase I trial of drug; |
CANCER | ||||
BioCryst |
Fodosine |
Purine nucleoside phosphorylase inhibitor |
T-cell acute |
European Medicines Agency granted orphan designation (11/17) Forodesine; transition state |
IDM Pharma |
Mepact |
Mifamurtide for injection |
Osteosarcoma |
Submitted marketing authorization application in Europe for its use in newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with postoperative multiagent chemotherapy (11/7) |
Peregrine |
Bavituximab |
Anti-phospholipid immunotherapy agent |
Cancer |
Started patient treatment in its Phase Ib trial of 12 patients at three sites in India (11/17) |
SkyePharma plc |
Solaraze |
Diclofenac; topical gel |
Actinic keratosis |
Australian regulators approved the product (11/28) |
CARDIOVASCULAR | ||||
Angiotech |
Vascular Wrap |
Paclitaxel-eluting product |
Peripheral arterial disease |
Data produced evidence of a reduced overall incidence of leg amputation and prolonged limb retention vs. the control group (11/9) |
Argenta |
ADC4022 |
Inhaled therapy |
Chronic obstructive pulmonary disease and severe asthma |
Started a Phase I trial with 36 volunteers (11/8) |
EPIX |
Vasovist |
Gadofosveset trisodium injection; blood pool imaging agent |
Vascular disease |
Health Canada approved Vasovist (11/6) |
INFECTION | ||||
AMDL Inc. |
Levoflocaxin |
Antibiotic; fluoroquinolone |
Pneumonia, urinary tract infections, kidney and skin infections |
Approved by Chinese regulatory authorities (11/17) |
Arrow |
A-831 |
Small-molecule antiviral inhibitor designed to target the NS5a protein |
Hepatitis C virus |
Started a Phase I study in the UK (11/27) |
Generex |
Antigen Express |
Synthetic vaccine based on simple peptide-synthesis technology |
Avian influenza |
Will conduct first clinical trial at the Lebanese-Canadian Hospital in Beirut (11/6) |
Protherics |
CytoFab |
Anti-TNF-alpha polyclonal antibody fragment |
Severe sepsis |
Expanded development with the addition of a 48-patient Phase II program (11/3) |
MISCELLANEOUS | ||||
DOR BioPharma |
orBec |
Oral beclomethasone dipropionate |
Gastrointestinal graft-vs.- host disease |
Submitted marketing authorization to the European Medicines Agency (11/7); European regulators accepted the application (11/28) |
Kamada Ltd. |
API |
Alpha 1-proteinase inhibitor |
Congenital emphysema and cystic fibrosis |
Started Phase I trials of an inhaled formulation (11/27) |
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. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange. | ||||
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