Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Celgene Corp. (Summit, N.J.) |
Abraxane |
Paclitaxel |
Pancreatic adenocarcinoma |
FDA approved it |
9/9/13 |
Genentech Inc. (South San Francisco) |
Perjeta |
Pertuzumab |
Breast cancer |
FDA committee supported approval of Perjeta |
9/13/13 |
Gilead Sciences Inc. (Foster City, Calif.) |
Idelalisib |
An oral inhibitor of P13k delta |
Indolent non-Hodgkin’s lymphoma |
Submitted an NDA |
9/13/13 |
TG Therapeutics Inc. (New York) |
TG-1101 |
Ublituximab |
Nodal and extranodal marginal zone lymphomas |
FDA granted orphan drug designation |
9/10/13 |
CARDIOVASCULAR | |||||
Chelsea Therapeutics International Ltd. (Charlotte, N.C.) |
Northera |
Droxidopa; an orally active synthetic precursor of norepinephrine |
Symptomatic neurogenic orthostatic hypotension |
FDA acknowledged receipt of the NDA |
9/6/13 |
United Therapeutics Corp. (Silver Spring, Md.) |
Treprostinil |
Treprostinil diolamine extended-release tablets |
Pulmonary arterial hypertension |
FDA acknowledged the resubmission of the NDA |
9/13/13 |
CENTRAL NERVOUS SYSTEM | |||||
Zalicus Inc. (Cambridge, Mass.) |
Z160 |
Oral, state-dependent, selective N-type calcium channel modulator |
Chronic neuropathic pain |
Received orphan drug designation from the FDA |
9/30/13 |
DIABETES | |||||
Zealand Pharma A/S (Copenhagen, Denmark) and Sanofi SA (Paris) |
Lixisenatide |
Once-daily glucagon-like peptide-1 receptor agonist |
Type II diabetes mellitus |
Sanofi withdrew the NDA, with plans to resubmit in 2015 after completing a cardiovascular outcomes trial |
9/13/13 |
INFECTION | |||||
Durata Therapeutics Inc. (Chicago) |
Dalbavancin |
Antibiotic |
Acute bacterial skin and skin structure infections |
Submitted the NDA |
9/30/13 |
RESPIRATORY | |||||
Theravance Inc. (South San Francisco) and Glaxosmithkline plc (London) |
Anoro Ellipta |
Inhaler product |
Chronic obstructive pulmonary disease |
FDA panel recommended approval |
9/11/13 |
MISCELLANEOUS | |||||
Dompe Group (Milan) |
Nerve growth factor |
Recombinant human nerve growth factor |
Retinitis pigmentosa |
Its drug candidate received orphan drug designation by the FDA |
9/12/13 |
Soligenix Inc. (Princeton, N.J.) |
SGX94 |
Innate defense regulator |
Acute radiation syndrome |
FDA granted orphan drug status |
9/17/13 |
Xenikos BV (Nijmegen, the Netherlands) |
T-Guard |
A combination of two toxin-loaded anti-T cell antibodies |
Graft-vs.-host disease |
FDA granted orphan drug designation |
9/19/13 |
|
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. | |||||
