Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Cipher Pharmaceuticals Inc. (Mississauga, Ont.) |
Cip-isotretinoin |
Formulation of isotretinoin |
Acne |
Submitted an amendment to its pending NDA; it includes additional clinical information requested by the FDA (11/28) |
Horizon Pharma Inc. (Deerfield, Ill.) |
Lodotra |
A modified delayed-release formulation of low-dose prednisone |
Rheumatoid arthritis |
FDA accepted the filing and will review its NDA (11/30) |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Arcalyst |
Rilonacept injection |
To prevent gout flares |
FDA has accepted the company's sBLA (11/23) |
CANCER | ||||
Bristol-Myers Squibb Co. (New York) |
Erbitux |
Cetuximab; monoclonal antibody |
Late-stage head and neck cancer |
FDA approved it for use with chemotherapy (11/8) |
EUSA Pharma Inc. (Oxford, UK) |
Erwinase |
Asparaginase Erwinia chrysanthemi |
Acute lymphoblastic leukemia |
FDA approved it (11/21) |
Genentech Inc. (South San Francisco) |
Avastin |
Bevacizumab |
Breast cancer |
FDA revoked the approval in the breast cancer indication because evidence showed the benefits did not outweigh the risks (11/21) |
Millennium (Cambridge, Mass.) |
Velcade |
Bortezomib |
Multiple myeloma |
FDA approved an sNDA, updating the label to include additional long-term overall survival data (11/3) |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Carfilzomib |
A next-generation proteasome inhibitor |
Relapsed and refractory multiple myeloma |
FDA accepted the new drug application (11/30) |
Pfizer Inc. (New York) |
Mylotarg |
Gemtuzumab ozogamicin |
Acute myeloid leukemia |
FDA has removed approval upon the company's request after a confirmatory trial failed to demonstrate clinical benefit and revealed safety concerns (11/29) |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Zevalin |
Ibritumomab tiuxetan |
Non-Hodgkin's lymphoma |
Received FDA approval to remove the pre-treatment bioscan requirement for Zevalin (11/22) |
SymBio Pharmaceuticals Ltd. (Tokyo) |
Treakisym |
Bendamustine hydrochloride |
Non-Hodgkin's lymphoma and mantle cell lymphoma |
Started a Phase II trial in Japan (11/15) |
CARDIOVASCULAR | ||||
Amarin Corp. plc (Dublin, Ireland) |
AMR101 |
A prescription-grade fish oil |
High triglycerides |
FDA has accepted its NDA (11/29) |
Chelsea Therapeutics International Ltd. (Charlotte, N.C.) |
Northera |
Droxidopa; an oral synthetic precursor of norepinephrine |
Symptomatic neurogenic orthostatic hypotension |
FDA accepted for filing its NDA (11/18) |
CENTRAL NERVOUS SYSTEM | ||||
IntelGenx Corp. (Saint Laurent, Quebec) |
CPI-300 |
A high-strength formulation of bupropion hydrochloride |
Major depressive disorder |
Gained FDA approval (11/15) |
Otsuka Pharmaceutical Co. Ltd. (Tokyo) |
Aripiprazole |
Depot formulation |
Schizophrenia |
FDA agreed that an NDA for maintenance treatment is sufficiently complete for review (11/28) |
Pacira Pharmaceuticals Inc. (Parsippany, N.J.) |
Exparel |
Bupivacaine liposome suspension, 1.3% |
Postsurgical pain relief |
Gained FDA approval (11/1) |
QRxPharma Ltd. (Sydney, Australia) |
MoxDuo |
Morphine/oxycodone |
Pain |
FDA plans to review the NDA with a PDUFA data of June 25, 2012 (11/9) |
Transcept Pharmaceutical Inc. (Point Richmond, Calif.) and Purdue Pharmaceutical Products LP (Stamford, Conn.) |
Intermezzo |
Zolpidem tartrate |
Insomnia |
FDA approved it for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep (11/28) |
Vivus Inc. (Mountain View, Calif.) |
Qnexa |
Phentermine/topiramate |
Obesity |
FDA accepted for filing and review the NDA (11/4) |
DIABETES | ||||
Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Diabetic macular edema |
Received a second complete response letter with the FDA saying the risks of adverse events in two Phase III trials were not offset by the benefits; the agency requested two additional trials (11/14) |
Furiex Pharmaceuticals Inc. (Morrisville, N.C.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Alogliptin/metformin |
Fixed-dose combination |
Type II diabetes |
Submitted an NDA (11/29) |
INFECTION | ||||
Santen Inc. (Emeryville, Calif.) |
DE-109 |
Sirolimus |
Chronic/refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis and non-infectious uveitis affecting the posterior segment of the eye |
FDA granted orphan drug designation for sirolimus (11/11) |
MISCELLANEOUS | ||||
Incyte Corp. (Wilmington, Del.) |
Jakafi |
Ruxolitinib; JAK inhibitor |
Myelofibrosis |
FDA approved it (11/17) |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Eylea |
Aflibercept |
Wet age-related macular degeneration |
FDA granted approval (11/22) |
Shire plc (Dublin, UK) |
Vpriv |
Velaglucerase alfa; an enzyme replacement therapy |
Gaucher's disease |
Submitted regulatory filings in the U.S. and Europe for the production of Vpriv (11/23) |
Summit Corp. (Oxford, UK) |
SMT C1100 |
A small-molecule drug that up-regulates production of a naturally occurring protein called utrophin to replace missing dystrophin |
Duchenne's muscular dystrophy |
FDA granted orphan drug status (11/29) |
|
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. | ||||