Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Curis Inc. (Lexington, Mass.) |
CUDC-427 |
An oral, small-molecule SMAC mimetic |
Solid tumors or lymphoma |
FDA said its complete response submission to the November 2013 partial clinical hold showed it is safe to proceed; it was placed on partial clinical hold following the death of a patient who progressed to liver failure approximately one month following discontinuation of CUDC-427 dosing |
4/1/14 |
Genmab A/S (Copenhagen) and Glaxosmithkline plc (London) |
Arzerra |
Ofatumumab; a CD20-directed monoclonal antibody |
Chronic lymphocytic leukemia |
FDA approved a supplemental BLA for the use of Arzerra in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate |
4/18/14 |
Kite Pharma Inc. (Santa Monica, Calif.) |
N/A |
An autologous engineered T-cell product designed to target CD19 expression |
B-cell malignancies |
FDA granted orphan drug designation |
4/1/14 |
Pharmacyclics Inc. (Sunnyvale, Calif.) |
Imbruvica |
Ibrutinib |
Chronic lymphocytic leukemia or small lymphocytic lymphoma |
Submitted a supplemental NDA, based on data from the phase III RESONATE study, PYC-1112, a head-to-head comparison of Imbruvica vs. Arzerra (ofatumumab, Genmab A/S and Glaxosmithkline plc) in 391 patients |
4/9/14 |
Tolero Pharmaceuticals Inc. (Salt Lake City) |
Alvocidib |
Flavopiridol |
Acute myeloid leukemia |
FDA granted orphan drug designation |
4/24/14 |
CARDIOVASCULAR | |||||
Biogen Idec Inc. (Cambridge, Mass.) |
Alprolix |
Coagulation Factor IX, Fc fusion protein |
Hemophilia B |
FDA approved it for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B |
4/1/14 |
Dyax Corp. (Cambridge, Mass.) |
Kalbitor |
Ecallantide; peptide inhibitor of plasma kallikrein |
Acute hereditary angioedema |
Won FDA approval to treat patients older than 12 years |
4/7/14 |
The Medicines Co. (Parsippany, N.J.) |
Fibrocabs |
A dry powder formulation of fibrinogen and thrombin |
To control mild or moderate bleeding |
FDA accepted the filing of a BLA for hemostatic agent Fibrocabs |
4/4/14 |
CENTRAL NERVOUS SYSTEM | |||||
Impax Pharmaceuticals (division of Impax Laboratories Inc.; Hayward, Calif.) |
IPX066 |
An extended-release capsule formulation of carbidopa and levodopa |
Parkinson's disease |
Resubmitted an NDA with updated safety and stability information |
4/14/14 |
Intelgenx Corp. (Saint Laurent, Quebec) and Redhill Biopharma Ltd. (Tel Aviv, Israel) |
Versafilm |
Oral thin-film formulation of rizatriptan |
Acute migraines |
FDA acknowledged receipt of the companies' response to the complete response letter and has requested further clarifications |
4/25/14 |
Kaleo Inc. (Richmond, Va.) |
Evzio |
Naloxone autoinjector |
Opioid overdose |
FDA approved it |
4/4/14 |
Pozen Inc. (Chapel Hill, N.C.) |
PA8140/PA32540 |
Gastrointestinal-friendly aspirin candidates |
Pain |
FDA issued a complete response letter |
4/29/14 |
Qrxpharma Ltd. (Sydney) |
Moxduo |
An immediate-release dual opioid (oxycodone and morphine) |
Moderate to severe acute pain |
FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend against approval |
4/24/14 |
DIABETES | |||||
Mannkind Corp. (Valencia, Calif.) |
Afrezza |
Insulin human [rDNA origin]) powder |
Type 1 and 2 diabetes |
FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended approval |
4/2/14 |
Psivida Corp. (Watertown, Mass.) and Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Diabetic macular edema |
The FDA set a PDUFA date of Sept. 26 for Iluvien following resubmission of the NDA |
4/15/14 |
INFECTION | |||||
Cubist Pharmaceutical Inc. (Lexington, Mass.) |
Sivextro |
Tedizolid |
Acute bacterial skin and skin structure infections |
FDA committee recommended approval, and a study specifically in adolescents and teens before the label is extended for pediatric use |
4/1/14 |
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
Ceftolozane/tazobactam |
Antibiotic |
Complicated urinary tract infections and complicated intra-abdominal infections |
Submitted an NDA |
4/22/14 |
Durata Therapeutics Inc. (Chicago) |
Dalvance |
Dalbavancin; a second-generation, semisynthetic lipoglycopeptide |
Acute bacterial skin and skin structure infections |
FDA committee recommended approval |
4/1/14 |
Edmond Pharma Srl (Milan) |
Erdosteine |
A small-molecule thiol product |
Bronchiectasis |
FDA granted orphan drug designation |
4/29/14 |
Emergent Biosolutions Inc. (Rockville, Md.) |
Biothrax |
Anthrax vaccine adsorbed |
Anthrax disease |
FDA has granted orphan drug designation |
4/22/14 |
Enanta Pharmaceuticals Inc. (Watertown, Mass.) and Abbvie Inc. (Chicago) |
ABT-450 |
Oral, interferon-free regimen |
Chronic genotype 1 HCV infection |
Submitted an NDA |
4/23/14 |
Gilead Sciences Inc. (Foster City, Calif.) |
Cobicistat |
A pharmaco-enhancing, or boosting, agent that increases blood levels of the protease inhibitors atazanavir and darunavir, and the integrase inhibitor elvitegravir |
HIV |
FDA accepted the company's refiling of two NDAs |
4/23/14 |
MISCELLANEOUS | |||||
Sarepta Therapeutics Inc. (Cambridge, Mass.) |
Eteplirsen |
Exon-skipping candidate |
Duchenne muscular dystrophy |
FDA said the NDA "should be fileable" with existing data |
4/22/14 |
RESPIRATORY | |||||
Alk-Abello A/S (Copenhagen) and Merck & Co. Inc. (Whitehouse Station, N.J.) |
Ragwitek |
An allergen extract |
Ragweed allergic rhinitis |
FDA approved the BLA for Ragwitek as an immunotherapy for short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen |
4/18/14 |
Greer Laboratories Inc. (Lenoir, N.C.) |
Oralair |
Under-the-tongue allergen extract |
Allergic rhinitis |
FDA approved Oralair to treat allergic rhinitis with or without conjunctivitis |
4/3/14 |
|
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. | |||||