| Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
| AUTOIMMUNE | ||||
Horizon Pharma Inc. (Northbrook, Ill.) |
Lodotra |
A delayed-release formulation of low-dose prednisone |
Active rheumatoid arthritis |
Submitted an NDA for Lodotra (9/29) |
Janssen Biotech Inc. (Johnson & Johnson subsidiary; Horsham, Pa.) |
Simponi |
Golimumab |
Active psoriatic arthritis |
FDA issued a complete response letter for the sBLA (9/13) |
| CANCER | ||||
4SC AG (Planegg-Martinsried, Germany) |
Resminostat |
Oral histone deacetylase inhibitor |
Hodgkin's lymphoma |
FDA granted a second orphan drug designation (9/27) |
Cell Therapeutics Inc. (Seattle) |
Pixuvri |
Pixantrone |
Non-Hodgkin's lymphoma |
A second independent radiology assessment of response and progression endpoint data from its PIX301 trial confirmed the statistical robustness of efficacy data; it will be used as part of the company's appeal of the complete response letter (9/29) |
Curis Inc. (Lexington, Mass.) and Genentech Inc. (South San Francisco) |
RG3616/GDC-0449 |
Vismodegib |
Basal cell carcinoma |
Filed an NDA (9/13) |
Onyx Pharmaceuticals Inc. (Emeryville, Calif.) |
Carfilzomib |
A next-generation proteasome inhibitor |
Multiple myeloma |
Onyx submitted the NDA based on Phase IIb data (9/29) |
Talon Therapeutics Inc. (San Mateo, Calif.) |
Marqibo |
Vincristine sulfate liposomes injection |
Newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia |
FDA accepted for filing the NDA under accelerated approval (9/28) |
| CARDIOVASCULAR | ||||
Amarin Corp. plc (Dublin, Ireland) |
AMR101 |
A prescription-grade omega-3 fatty acid consisting of ultra pure icosapent ethyl |
High triglycerides |
Submitted its NDA (9/27) |
Chelsea Therapeutics International Ltd. (Charlotte, N.C.) |
Northera |
Droxidopa; an orally active synthetic precursor of norepinephrine |
Symptomatic neurogenic orthostatic hypotension |
Filed an NDA (9/29) |
Discovery Laboratories Inc. (Warrington, Pa.) |
Surfaxin |
Lucinactant; an aerosolized KL4 surfactant |
To prevent respiratory distress syndrome in premature infants |
FDA accepted its response to a 2009 complete response letter for Surfaxin (9/29) |
Tarix Pharmaceuticals Ltd. (Cambridge, Mass.) |
TXA127 |
An angiotensin peptide |
Pulmonary arterial hypertension |
FDA granted TXA127 orphan status (9/29) |
| CENTRAL NERVOUS SYSTEM | ||||
NeurogesX Inc. (San Mateo, Calif.) |
Qutenza |
Capsaicin patch |
Postherpetic neuralgia |
Submitted an sNDA (9/9) |
Transcept Pharmaceuticals Inc. (Point Richmond, Calif.) |
Intermezzo |
Zolpidem tartrate sublingual tablet |
Insomnia |
Resubmitted its NDA following a meeting with the FDA to discuss issues raised in the July complete response letter (9/29) |
| MISCELLANEOUS | ||||
Accentia Biopharma-ceuticals Inc. (Tampa, Fla.) |
Revimmune |
Active ingrident: cytoxan |
Graft-vs.-host disease |
Granted orphan drug designation (9/15) |
Alexion Pharmaceutical Inc. (Cheshire, Conn.) |
Soliris |
Terminal complement inhibitor; eculizumab |
Atypical hemolytic uremic syndrome |
Alexion won accelerated FDA approval for the drug (9/26) |
Apotex Group (Toronto) |
Ferriprox |
Deferiprone |
Transfusional iron overload |
FDA's Oncologic Drugs Advisory Committee voted 10 to 2 in favor of accelerated approval (9/15) |
Discovery Labs Inc. (Warrington, Pa.) |
Surfaxin |
Lucinactant |
To prevent respiratory distress syndrome in premature infants |
Submitted its response to the 2009 complete response letter the FDA issued (9/7) |
Janssen Biotech Inc. (Horsham, Pa.) |
Remicade |
Infliximab |
Ulcerative colitis |
FDA approved Remicade to treat moderately to severely active ulcerative colitis in children older than 6 years who have had inadequate response to conventional therapy (9/27) |
Vivus Inc. (Mountain View, Calif.) |
Avanfil |
A selective phosphodiesterase type 5 inhibitor |
Erectile dysfunction |
FDA accepted its NDA (9/6) |
|
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. | ||||
