Company (Location)

Product

Description

Indication

Status (Date)#


AUTOIMMUNE

Cipher Pharmaceuticals Inc. (Mississauga, Ontario)

Cip-isotretinoin

Formulation of acne drug isotretinoin

Acne

An amendment to the NDA has been accepted by the FDA as a complete, class II response (12/22)

Pfizer Inc. (New York)

Tofacitinib

Oral JAK inhibitor

Active rheumatoid arthritis

FDA accepted for review its NDA (12/21)

CANCER

Cell Therapeutics Inc. (Seattle)

Pixantrone

An aza-anthracenedione that inhibits Topo-isomerase II

Non-Hodgkin's lymphoma

FDA accepted its resubmitted NDA (12/7)

Emergent BioSolutions Inc. (Rockville, Md.)

TRU-016

Humanized anti-CD37 mono-specific protein therapeutic

B-cell malignancies

FDA granted orphan drug designation (12/2)

CARDIOVASCULAR

United Therapeutics Corp. (Silver Spring, Md.)

Tresprostinil

Prostacyclin vasodilator

Pulmonary arterial hypertension

Submitted an NDA (12/28)

CENTRAL NERVOUS SYSTEM

Alexza Pharmaceuticals Inc. (Mountain View, Calif.)

Adasuve

Staccato loxapine

Agitation in schizophrenia and bipolar disorder

FDA has questioned the safety of the drug-device combination product, especially in patients with asthma or COPD (12/9); committee voted 17-1 that it was effective, but 9-8, with two abstentions, to recommend approval of a single dose in 24 hours (12/13)

Endo Pharmaceuticals Holdings Inc. (Chadds Ford, Pa.) and Grunenthal GmbH (Aachen, Germany)

Opana ER

New formulation that incorporates INTAC technology

Pain

FDA approved a crush-resistant formulation (12/13)

Impax Pharmaceuticals (Hayward, Calif.)

IPX066

An extended-release capsule formulation of carbidopa-levodopa

Idiopathic Parkinson's disease

Submitted an NDA (12/22)

INFECTION

Gilead Sciences Inc. (Foster City, Calif.)

Truvada

Emtricitabine/tenofovir disoproxil fumarate

HIV

Gilead submitted an sNDA for pre-exposure prophylaxis (12/19)

Gilead Sciences Inc. (Foster City, Calif.)

Quad

Single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate

HIV

FDA accepted for review the NDA (12/28)

Merck & Co. Inc. (Whitehouse Station, N.J.)

Isentress

Raltegravir

HIV

FDA gave approval for its use with other antiretroviral drugs to treat HIV in children and adolescents age 2-18 (12/22)

Napo Pharmaceuticals Inc. (San Francisco) and Salix Pharmaceuticals Inc. (Raleigh, N.C.)

CRO-ID

Crofelemer

HIV-associated diarrhea

Salix submitted an NDA (12/15)

ViroPharma Inc. (Exton, Pa.)

Vancocin

Antibiotic; vancomycin

Clostridium difficile infection

FDA approved an sNDA that modernizes the labeling, including the addition of clinical safety and efficacy data for the drug in treating currently circulating strains (12/15)

MISCELLANEOUS

Affymax Inc. (Palo Alto, Calif.)

Peginesatide

Injection; formerly Hematide

Anemia associated with chronic kidney disease

The Oncologic Drugs Advisory Committee endorsed, by a 15-1 margin, the benefit/risk profile in adult patients on dialysis (12/8)

Antares Pharma Inc. (Ewing, N.J.) and Watson Pharmaceuticals Inc. (Parsippany, N.J.)

Oxybutynin gel

Delivered transdermally through a metered-dose pump

Overactive bladder

FDA approved it to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency (12/9)

NPS Pharmaceuticals Inc. (Bedminster, N.J.)

Gattex

Teduglutide

Short bowel syndrome

Completed its NDA submission (12/2)

Santarus Inc. (San Diego)

Uceris

A locally acting, nonsystemic corticosteroid

Ulcerative colitis

Submitted its NDA (12/22)

ThromboGenics NV (Leuven, Belgium)

Ocriplasmin

Intravitreal injection

Symptomatic vitreomacular adhesion

Filed a BLA (12/28)

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Kalydeco

Ivacaftor

Cystic fibrosis

FDA accepted the NDA (12/16)


Notes:

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

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.