Selected products up for approval in 2013. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Actelion Ltd. (SIX:ATLN)

Opsumit macitentan

Pulmonary arterial hypertension (PAH)

PDUFA date

October

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

MAA action

Mid-2013

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

Adasuve Staccato loxapine

Schizophrenia or bipolar disorder

MAA action

1Q13

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)/ Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)/ Ildong Pharmaceutical Co. Ltd.

Belviq lorcaserin

Chronic weight management

MAA action

1H13

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/ Astellas Pharma Inc. (Tokyo:4503)/ Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Tivopath tivozanib

Renal cell carcinoma (RCC)

PDUFA date

7/28/13

Bavarian Nordic A/S (CSE:BAVA)

Imvanex vaccine

Prevent smallpox infection

MAA action

2013

Bayer AG (Xetra:BAYN)/Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

Regorafenib

Metastatic and/or unresectable gastrointestinal stromal tumors (GIST)

PDUFA date

1Q13

Biogen Idec Inc. (NASDAQ:BIIB)

BG-12

Multiple sclerosis (MS)

PDUFA date

Early 2013

BioMimetic Therapeutics Inc. (NASDAQ:BMTI)

Augment Bone Graft

Alternative to the use of autograft in foot and ankle fusions

PMA action

2013