Company
(Location)

Product

Description

Indication

Status

Date

CANCER

Algeta ASA (Oslo, Norway) and Bayer AG (Leverkusen, Germany)

Alpharadin

Radium-223 dichloride

Castration-resistant prostate cancer patients with bone metastases

Submitted an MAA to the EMA

12/13/12

Exelixis Inc. (South San Francisco)

Cometriq

Cabozantinib

Progressive, unresectable, locally advanced or metastatic medullary thyroid cancer

EMA accepted for review the MAA

12/3/12

CARDIOVASCULAR

Celladon Corp. (San Diego)

Mydicar

Single, intracoronary administration

Heart failure

Dosed its first patient in Europe in a Phase IIb trial

12/13/12

Genzyme Corp. (Cambridge Mass.) and Isis Pharmaceuticals Inc. (Carlsbad, Calif.)

Kynamro

Mipomersen

Homozygous familial hypercholesterolemia

The CHMP of the EMA has adopted a negative opinion for its MAA

12/17/12

CENTRAL NERVOUS SYSTEM

Biotie Therapies Oyj (Turku, Finland)

Selincro

Nalmefene

Alcohol dependence

EMA's CHMP recommended approval

12/17/12

Eisai Inc. (Woodcliff Lake, N.J.)

Fycompa

Perampanel

Partial epilepsy

Was approved for use in Scotland

12/11/12

Paladin Labs Inc. (Montreal)

Silenor

Doxepin hydrochloride

Insomnia

Health Canada approved it for the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening and/or early morning awakening

12/19/12

DIABETES

pSivida Corp. (Watertown, Mass.)

Iluvien

An intravitreal implant that delivers fluocinolone acetonide

Chronic diabetic macular edema

UK's National Institute for Health and Clinical Excellence (NICE) issued a final draft guidance indicating it is not recommended for the treatment of DME because evidence provided did not show that the product's benefit to patients justified the proposed price

12/3/12

INFECTION

Intercell AG (Vienna, Austria)

Ixiaro

Vaccine

Japanese encephalitis

CHMP issued a positive opinion on an MAA

12/20/12

MISCELLANEOUS

Genzyme Corp. (Cambridge, Mass.)

Thyrogen

Thyrotropin alfa

Postoperative thyroid remnant ablation

European Commission approved a product label expansion

12/10/12

Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Bayer AG (Leverkusen, Germany)

Eylea

Aflibercept injection

Macular edema following central retinal vein occlusion

Bayer submitted an MAA in Europe

12/7/12

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Kalydeco

Ivacaftor

Cystic Fibrosis

Health Canada approved it in people older than 6 with at least one copy of the G551D mutation of the CFTR gene

12/4/12


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.