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. |