Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

CANCER

Amgen Inc. (AMGN)

Vectibix (FDA-approved)

Panitumumab; fully human monoclonal antibody directed against the epidermal growth factor receptor

Colorectal cancer

Amgen is appealing the negative opinion on the marketing clearance of Vectibix from the CMPH (5/25)

Ark Therapeutics Group plc (UK; PK:ARKTF)

Cerepro

Gene therapy

Glioma

EMEA said it would not give approval without further analysis of Phase II data, or new data from a Phase III trial (5/2)**

Can-Fite BioPharma* (Israel)

CF101

Agent that targets the A3 adenosine receptor

Psoriasis

Received Ministry of Health and EC approval to begin Phase II trials (5/16)

Genentech Inc. (NYSE:DNA) and F. Hoffmann-La Roche Ltd. (Switzerland)

Herceptin (FDA-approved)

Trastuzumab

Metastatic breast cancer

European Commission approved its use in combination with an aromatase inhibitor in patients with HER2 and horomone receptor co-positive metastatic breast cancer (5/3)

HUYA Bioscience International LLC* and Chipscreen Biosciences Ltd.* (China)

Chidamide/HBI-800

An orally bioavailable histone deacetylase inhibitor derived from the benzamide class

Cancer

Phase I trial was initiated in China (5/23)

Indevus Pharmaceuticals Inc. (IDEV)

Vantas

Histrelin acetate subcutaneous implant

Prostate cancer

European regulators expanded approval to five new countries, the UK, Ireland, Germany, Spain and Italy; it was approved in Denmark in 2005 (5/31)

Oncoloytics Biotech Inc. (Canada; ONCY; TSX:ONC)

Reolysin

Intravenous formulation of the human reovirus that targets the activated Ras pathway

Advanced cancers

Started enrolling patients in a UK trial of Reolysin in combination with paclitaxel and carboplatin (5/29)

CARDIOVASCULAR

Cardiome Pharma Corp. (Canada; CRME; TSX:COM) and Astellas Pharma Canada Inc.

Vernakalant hydrochloride

Intravenous formulation

For acute conversion of atrial fibrillation

Filed a new drug submission with Health Canada (5/30)

Encysive Pharmaceuticals Inc. (ENCY)

Thelin

Sitaxsentan sodium; 100-mg tablets

Pulmonary arterial hypertension

Canadian authorities approved Thelin (5/31)

Pharmaxis Ltd. (Australia; PXSL)

Aridol

Mannitol formulation delivered via an inhalation device

Chronic obstructive pulmonary disease

First patients have been enrolled in a Swiss trial evaluating Aridol's ability to predict the response to inhaled steroids (5/15)

CENTRAL NERVOUS SYSTEM

BioLineRx Ltd.* (Israel)

BL-1020

GABA enhanced anti-psychotic candidate

Schizophrenia

Began a randomized, open-label study in Sweden (5/16)

DIABETES

Oramed Pharmaceuticals Inc. (Israel; OTC BB:ORMP)

Oral Insulin

Orally ingestible soft gel capsule

Diabetes

Began a Phase I trial in Israel (5/8)

INFECTION

Astellas Pharma Inc. (Japan; PK:ALPMF) and Theravance Inc. (THRX)

Telavancin

An injectable antibiotic; lipoglycopeptide

Complicated skin and soft tissue infections

Submitted an MAA to the EMEA (5/1)

Avir Green Hills Biotechnology* (Austria)

FluVacc

Influenza vaccine based on the deletion of the NS1 gene

Influenza

Started the first Phase I study in Vienna (5/16)

Crucell NV (the Netherlands; CRXL)

AERAS-402

AdVac-based tuberculosis vaccine developed using PER.C6 manufacturing technology

Tuberculosis

Crucell, the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative launched a Phase I trial in South Africa (5/11)

Omrix Biopharmaceuticals Inc. (OMRI)

HBIG

Hepatitis B immunoglobulin

Hepatitis B virus

Filed for approval in Sweden (5/7)

Sinovac Biotech Ltd. (China; AMEX:SVA)

Panflu

A vaccine against the H5N1 strain of pandemic influenza virus

Influenza

Was granted approval in China to start Phase II trials (5/9)

Theravance Inc. (THRX)

Telavancin

ipoglycopeptide; bactericidal injectable antibiotic

Complicated skin and soft tissue infections

European regulators accepted an application for the marketing of telavancin (5/31)

Angiotech Pharmaceuticals Inc. (Canada; TSX:ANP; ANPI)

Vascular Wrap

Paclitaxel-eluting mesh

End-stage renal disease

Began a study in Europe to evaluate the safety and efficacy of the wrap after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular access (5/30)

Ardana plc (UK; LSE:ARA)

ARD-07

An oral growth hormone secretagogue

Growth hormone deficiency

Was granted orphan drug status (5/23)**

Clinuvel Pharmaceuticals Ltd. (Australia; ASX:CUV)

CUV1647

Agent designed to stimulate production of eumelanin

Polymorphic light eruption

Began a Phase III trial in Europe (5/21)

Debiopharm Group* (Switzerland)

Salvacyl/Moapar

Sustained-release formulation; gonadotropin-releasing hormone agonist analogue

Sexual deviations

Completed European mutual recognition procedure in Germany, Belgium, Denmark, Finland, France, Norway, the Netherlands and the UK; it was approved last year in Sweden (5/24)

Progenics Pharmaceuticals Inc. (PGNX)

MNTX

Methylnaltrexone; peripherally acting opioid-receptor antagonist

Opioid-induced constipation

Filed for European approval (5/14)

Scil Technology GmbH* (Germany)

MD05

Comprises a synthetic carrier linked to recombinant human growth and differentiation factor-5

Periodontal disease

Gained regulatory approval to begin a Phase II trial (5/23)**

Tercica Inc. (TRCA)

Increlex

Mecasermin; 10 mg/mL solution for injection

Severe primary insulin-like growth factor-1 deficiency

CMPH adopted a positive opinion recommending European marketing authorization for Increlex (5/25)

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.

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