Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genzyme Corp. (Cambridge, Mass.; unit of Sanofi SA) |
Lemtrada |
Alemtuzumab |
Relapsing multiple sclerosis |
Submitted a supplemental BLA to the FDA and an MAA to the EMA seeking approval |
6/13/12 |
CANCER | |||||
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-TTR02 |
A systemically delivered RNAi therapeutic |
Familial amyloidotic polyneuropathy |
FDA granted orphan drug designation |
6/20/12 |
Ariad Pharmaceuticals Inc. (Cambridge, Mass.) and Merck & Co. Inc. (Whitehouse Station, N.J.) |
Taltorvic |
Ridaforolimus |
Metastatic sarcoma |
FDA issued a complete response letter |
6/7/12 |
Coronado Biosciences Inc. (Burlington, Mass.) |
CNDO-109 |
Activates the immune system's natural killer cells |
Acute myeloid leukemia |
FDA granted orphan drug status |
6/20/12 |
Genentech Inc. (South San Francisco) |
Perjeta |
Pertuzumab |
HER2-positive breast cancer |
FDA approved it |
6/12/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Kyprolis |
Carfilzomib |
Relapsed and refractory multiple myeloma |
FDA's Oncologic Drugs Advisory Committee voted 11-0, with one abstention, that the benefits outweigh the risks as a third-line treatment |
6/21/12 |
Repligen Corp. (Waltham, Mass.) |
RG1068 |
Synthetic human secretin; pancreatic imaging agent |
Pancreatic cancer |
Received a complete response letter on the NDA, asking for additional clinical efficacy and safety trial data |
6/25/12 |
CARDIOVASCULAR | |||||
CSL Behring (King of Prussia, Pa.) |
rIX-FP |
A recombinant fusion protein linking coagulation factor IX with recombinant albumin |
Bleeding episodes in patients with congenital factor IX deficiency |
Received FDA orphan drug designation |
6/11/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alexza Pharmaceuticals Inc. (Mountain View, Calif.) |
Adasuve |
Staccato loxapine |
Schizophrenia or bipolar I disorder |
Resubmitted its NDA |
6/25/12 |
Arena Pharmaceuticals Inc. (San Diego) |
Belviq |
Lorcaserin |
Obesity |
FDA approved it for chronic weight management, in addition to a reduced-calorie diet and exercise in adults with a body mass index of 30 or greater, or with a BMI of 27 or greater who have had at least one weight-related condition |
6/28/12 |
Pfizer Inc. (New York; product acquired through FoldRx Pharmaceuticals Inc. acquisition) |
Tafamidis meglumine |
Designed to stabilize the misfolding transthyretin protein to prevent further accumulation of amyloid fibrils on the nerve tissue |
Transthyretin familial amyloid polyneuropathy |
FDA issued a complete response letter for the NDA, asking for a second efficacy trial |
6/20/12 |
Supernus Pharmaceuticals Inc. (Rockville, Md.) |
Trokendi XR |
Once-daily extended-release topiramate (SPN-538) |
Epilepsy |
FDA issued a tentative approval letter, with final approval contingent on resolving market exclusivity questions related to the pediatric population |
6/27/12 |
XenoPort Inc. (Santa Clara, Calif.) and GlaxoSmithKline plc (London) |
Horizant |
Gabapentin enacarbil extended-release tablets |
Postherpetic neuralgia |
FDA approved it for the expanded label |
6/8/12 |
INFECTION | |||||
Dynavax Technologies Corp. (Berkeley, Calif.) |
Heplisav |
Vaccine |
Hepatitis B virus |
FDA accepted the BLA |
6/27/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
Elvitegravir |
An integrase inhibitor |
HIV-1 infection |
Submitted an NDA |
6/29/12 |
MISCELLANEOUS | |||||
Raptor Pharmaceutical Corp. (Novato, Calif.) |
RP103 |
Cysteamine bitartrate delayed-release capsules |
Nephropathic cystinosis |
NDA was accepted for review by the FDA |
6/15/12 |
Regenicin Inc. (Little Falls, N.J.) |
PermaDerm |
A tissue-engineered skin prepared from autologous skin cells consisting of both epidermal and dermal layers |
Catastrophic burn patients |
FDA granted orphan status to PermaDerm |
6/13/12 |
|
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. | |||||