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UK's National Institute for Health and Clinical Excellence (NICE) issued a final draft guidance indicating it is not recommended for the treatment of DME because evidence provided did not show that the product's benefit to patients justified the proposed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