| Company* |
Product |
Description |
Indication |
Status (Date)# |
| CANCER | ||||
Cell Therapeutics Inc. |
Pixuvri |
Pixantrone dimaleate |
Non-Hodgkin's lymphoma |
Company intends to appeal the FDA's decision on its NDA that the company should conduct an additional trial prior to approval (12/6) |
Elorac Inc. |
Naloxone |
Lotion; opiate antagonist also available via injection |
Pruritus accompanying cutaneous T-cell lymphoma |
Received orphan drug designation from the FDA (12/1) |
Genentech Inc. |
Avastin |
Bevacizumab |
HER2-negative metastatic breast cancer |
FDA is trying to get the indication stricken from labeling because four follow-up studies failed to demonstrated that the drug prolonged overall survival (12/17) |
Johnson & Johnson |
Abiraterone acetate |
Oral androgen biosynthesis inhibitor |
Metastatic prostate cancer |
Submitted marketing applications in the U.S. and Europe (12/22) |
| CARDIOVASCULAR | ||||
AstraZeneca plc (UK) |
Brilinta |
Ticagrelor; an oral antiplatelet treatment |
Acute coronary syndromes |
FDA has issued a complete response letter (12/20) |
Santarus Inc. and Pharming Group NV (the Netherlands) |
Rhucin |
Recombinant human C1 inhibitor |
Acute angioedema |
Submitted a BLA (12/29) |
| CENTRAL NERVOUS SYSTEM | ||||
Arena Pharmaceuticals Inc. |
Lorqess |
Lorcaserin |
Obesity |
Completed an end-of-review meeting with the FDA and plans to resubmit an NDA by the end of 2011 (12/23) |
Cephalon Inc. |
Nuvigil |
Armodafinil |
Jet lag |
Company dropped development after a second complete response letter from the FDA (12/28) |
Orexigen Therapeutics Inc. |
Contrave |
Naltrexone/bupropion |
Obesity |
FDA committee voted 13 to 7 in favor of the drug (12/8) |
Pacira Pharmaceuticals Inc. |
Exparel |
A bupivacaine |
Postsurgical pain |
FDA accepted for review the NDA (12/15) |
Pain Therapeutics Inc. and King Pharmaceuticals Inc. |
Remoxy |
A twice-daily formulation of oxycodone |
Pain |
Resubmitted its NDA (12/28) |
Valeant Pharmaceuticals International Inc. (Canada) and GlaxoSmithKline plc (UK) |
Ezogabine |
Formerly retigabine |
Epilepsy |
FDA issued a complete response for ezogabine as an adjunctive treatment for adults with parial onset seizures; the FDA cited nonclinical reasons for its action (12/3) |
Vivus Inc. |
Qnexa |
Phentermine/topiramate controlled-release capsules |
Obesity |
Submitted a briefing document to the FDA to address items in the Oct. 28 complete response letter (12/15) |
| DIABETES | ||||
Alimera Sciences Inc. and pSivida Corp. |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Diabetic macular edema |
FDA issued a complete response letter (12/28) |
Amylin Pharmaceuticals Inc. and Eli Lilly and Co. |
Byetta |
Exenatide |
Type II diabetes |
Submitted an sNDA seeking approval as an add-on therapy to basal insulin (12/27) |
Amylin Pharmaceuticals Inc. |
Metreleptin |
Recombinant methionyl human leptin |
Diabetes and hypertryglyceridemia |
Began submission of a rolling BLA (12/21) |
| INFECTION | ||||
Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. |
Acurox |
Oxycodone HCl tablets |
Moderate to severe pain |
King submitted an NDA (12/21) |
AstraZeneca plc (UK) |
Rezield |
Motavizumab |
Respiratory syncytial virus |
Dropped development as a prevention to RSV and withdrew the BLA, following two complete response letters; it is remaining in development for RSV treatment (12/22) |
Cubist Pharmaceuticals Inc. |
Cubicin |
An antibiotic |
Methicillin-resistant Staphylococcus aureus |
Approved by the FDA for once-a-day intravenous injection (12/3) |
Optimer Pharmaceuticals Inc. |
Fidaxomicin |
Antibiotic |
C. difficile infection |
Completed the submission of its NDA (12/1) |
| MISCELLANEOUS | ||||
Cleveland BioLabs Inc. |
CBLB502 |
Targets a mutation in the TLR5 gene |
To prevent death following total body irradiation |
Received orphan drug status to treat exposure to radiation (12/1) |
Endo Pharmaceuticals Inc. |
Fortesta |
Testosterone 2% gel |
Low testosterone |
Received FDA approval of Fortesta (12/30) |
Fibrocell Science Inc. |
Azficel-T |
An autologous cell therapy |
For nasolabial folds and wrinkles |
Submitted a complete response to the FDA for azficel-T (12/21) |
Marina Biotech Inc. |
CEQ508 |
Therapeutic agent that uses the transkingdom RNA interference platform; orally administered RNAi-based therapeutic |
Familial adenomatous polyposis |
FDA granted orphan drug designation (12/30) |
NeuroVive Pharmaceutical AB (Sweden) |
NeuroSTAT |
Cyclosporine |
Traumatic brain injury |
Granted orphan drug status (12/7) |
QLT Inc. (Canada) |
QLT091001 |
Oral, synthetic retinoid |
Retinitis pigmentosa and Leber congenital amaurosis |
FDA granted orphan designation for both indications (12/8) |
|
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. | ||||
