Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Biolinerx Ltd. (Jerusalem) |
BL-8040 |
A short peptide that functions as a high-affinity antagonist for chemokine receptor CXCR4 |
Acute myeloid leukemia |
FDA confirmed orphan drug designation for BL-8040, in combination with granulocyte colony-stimulating factor, as a treatment for stem cell mobilization prior to an autologous or allogeneic transplantation |
1/24/14 |
Cell Therapeutics Inc. (Seattle) |
IND 075503 |
Tosedostat; a first-in-class selective inhibitor of aminopeptidases |
Blood-related cancers |
Received word from the FDA that the partial clinical hold has been removed and all studies under way may continue |
1/3/14 |
CARDIOVASCULAR | |||||
Chelsea Therapeutics International Ltd. (Charlotte, N.C.) |
Northera |
Droxidopa |
Symptomatic neurogenic orthostatic hypotension |
FDA committee voted 16-1 to recommend the drug's approval in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and nondiabetic autonomic neuropathy |
1/15/14 |
CENTRAL NERVOUS SYSTEM | |||||
Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.) |
AVP-825 |
Uses Optinose AS' closed-palate breath powered intranasal delivery system |
Migraine |
Submitted an NDA to the FDA for AVP-825 for the acute treatment of migraine |
1/31/14 |
Orexigen Therapeutics Inc. (San Diego) |
Contrave |
Naltrexone sustained release/bupropion |
Obesity |
FDA considered the recent resubmission of the NDA to be a complete response to the Jan. 31, 2011, action letter |
1/8/14 |
Salix Pharmaceuticals Ltd. (Raleigh, N.C.) |
Budesonide |
2-mg rectal foam |
Active mild to moderate distal ulcerative colitis |
FDA accepted its NDA |
1/31/14 |
Iroko Pharmaceuticals LLC (Philadelphia) |
Zorvolex |
Diclofenac, a lower-dose nonsteroidal anti-inflammatory drug |
Osteoarthritis pain in adults |
FDA accepted for review the sNDA |
1/16/14 |
Aeolus Pharmaceuticals Inc. (Mission Viejo, Calif.) |
AEOL 10150 |
Antioxidant drug |
Acute radiation syndrome |
FDA granted orphan status for use in patients exposed to radiation following a nuclear accident or detonation in order to treat or mitigate acute radiation syndrome |
1/27/14 |
MISCELLANEOUS | |||||
Aeterna Zentaris Inc. (Quebec City) |
Macimorelin acetate |
Ghrelin agonist |
Adult growth hormone deficiency |
FDA has accepted for filing the company's NDA |
1/7/14 |
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab |
To prevent delayed graft function in renal transplant patients |
FDA granted orphan drug designation |
1/22/14 |
Amag Pharmaceuticals Inc. (Waltham, Mass.) |
Feraheme |
Ferumoxytol injection |
Iron deficiency anemia |
FDA confirmed that it is reviewing the sNDA for Feraheme in adult patients who failed or could not tolerate oral iron; FDA issued a complete response letter |
1/23/14 |
Brabant Pharma (London) |
Brabafen |
Low-dose fenfluramine |
Dravet syndrome |
FDA and European Commission granted orphan drug designation to treat children with Dravet syndrome |
1/10/14 |
Clarus Therapeutics Inc. (Northbrook, Ill.) |
Rextoro |
Oral testosterone replacement product |
Testosterone deficiency |
Submitted an NDA to the FDA |
1/15/14 |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Natpara |
Recombinant human parathyroid hormone 1-84 |
Hypopara-thyroidism |
FDA has accepted and filed for review the company’s BLA |
1/9/14 |
Regenerx Biopharma-ceuticals Inc. (Rockville, Md.) |
Tbeta4 |
Thymosin beta 4 |
Neurotrophic keratopathy |
Received orphan drug designation from the FDA |
1/6/14 |
Vivus Inc. (Mountain View, Calif.) and Auxilium Pharmaceuticals Inc. (Chesterbrook, Pa.) |
Stendra |
Avanafil |
Erectile dysfunction |
FDA accepted the sNDA proposing to revise prescribing information for Stendra with efficacy and safety information from Study TA-501, a multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of Stendra approximately 15 minutes after dosing |
1/22/14 |
RESPIRATORY | |||||
Alitair Pharmaceuticals Inc. (Morristown, N.J.) |
Erdotin |
Erdosteine |
Chronic obstructive pulmonary disease and chronic bronchitis |
FDA granted orphan drug designation |
1/8/14 |
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. |