Company (Location)

Product

Description

Indication

Status (Date)#

Celgene International Sarl (Boudry, Switzerland)

Revlimid

Lenalidomide

Multiple myeloma

European Committee for Medicinal Products for Human Use issued a positive opinion for Revlimid in combination with dexamethasone (9/26)

Eli Lilly and Co. (Indianapolis)

Alimta

Pemetrexed for injection

Nonsquamous non-small-cell lung cancer

Received a positive opinion from the CHMP as continuation maintenance therapy (9/27)

Janssen-Cilag International NV (Beerse, Belgium; a Johnson & Johnson subsidiary)

Zytiga

Abiraterone acetate; a once-daily, oral, androgen biosynthesis inhibitor

Metastatic castration-resistant prostate cancer

European Commission approved Zytiga (9/8)

Cipher Pharmaceuticals Inc. (Mississauga, Ont.)

CIP-Tramadol ER

An extended-release tramadol product

Moderate to moderately severe chronic pain

Health Canada approved it (9/1)

ViroPharma Inc. (Exton, Pa.)

Buccolam

Midazolam, oromucosal solution

Prolonged, acute, convulsive seizures

Received a Centralized Pediatric Use Marketing Authorization from the European Commission (9/7)

Furiex Pharmaceuticals Inc. (Morrisville, N.C.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Liovel

A fixed-dose combination tablet of Nesina and Actos

Type II diabetes

Launched two dosages in Japan (9/21)

Novartis AG (Basel, Switzerland)

Lucentis

Ranibizumab

Diabetic macular edema

Health Canada approved Lucentis (9/15)

Gilead Sciences Inc. (Foster City, Calif.)

Eviplera

Combines Gilead's Truvada with Edurant (Tibotec Pharmaceuticals)

HIV

The CHMP adopted a positive opinion on the MAA for the once-daily, single-tablet regimen (9/26)

Mitsubishi Tanabe Pharma Corp. (Osaka, Japan)

Telavic

Telaprevir

Chronic hepatitis C virus

Received approval for the manufacturing and marketing of Telavic in Japan (9/28)

Optimer Pharmaceuticals Inc. (San Diego)

Dificlir

Fidaxomicin

Clostridium difficile infection

The EMA adopted a positive opinion of Dificlir (9/26)

Thallion Pharmaceuticals Inc. (Montreal)

Shigatec

Anti-Stxl monoclonal antibody

Shiga toxin-producing E. coli bacteria infections

Company will resume patient recruitment in its Phase II study in South America (9/14)

Theratechnol-ogies Inc. (Montreal) and Sanofi SA (Paris)

Egrifta

Tesamorelin for injection

HIV

lipodystrophy

Filed for approval in Brazil (9/1); filed an MAA in Argentina (9/2)

Theravance Inc. (South San Francisco) and Astellas Pharma Inc. (Tokyo)

Vibativ

Antibiotic; telavancin

Nosocomial pneumonia

Received European approval of Vibativ (9/16)

Vertex Pharmaceuticals Inc. (Cambridge, Mass.) and Johnson & Johnson (New Brunswick, N.J.)

Telaprevir

Protease inhibitor

Hepatitis C virus

Received European approval for use with pegylated-interferon and ribavirin (9/21)

Advanced Cell Technology Inc. (Marlborough, Mass.)

RPE

Retinal pigment epithelium derived from human embryonic stem cells

Stargardt's macular dystrophy

Received clearance from the UK Medicines and Healthcare products Regulatory Agency to treat patients as part of a Phase I/II trial (9/23)

Alexion Pharmaceutical Inc. (Cheshire, Conn.)

Soliris

Terminal complement inhibitor; eculizumab

Atypical hemolytic uremic syndrome

Received a positive recommendation in Europe (9/26)

Ironwood Pharmaceuticals Inc. (Cambridge, Mass.) and Almirall SA (Barcelona, Spain)

Linaclotide

A guanylate cyclase typeC agonist

Irritable bowel syndrome with constipation

Almirall submitted an MAA to the EMA (9/30)

Notes:

CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

# The date indicated refers to the BioWorld Today issue in which the news item can be found.