Company* (Country; Symbol) | Product | Description | Indication |
Status (Date) |
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AUTOIMMUNE | ||||
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Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Tysabri |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
FDA advisory panel unanimously recommended reintroduction of drug as a treatment for relapsing forms of MS (3/8); the FDA extended its review by 90 days; action is expected by June 28 (3/22) |
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CANCER | ||||
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Amgen Inc. (AMGN) |
Panitumumab |
Fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
Completed rolling BLA submission that seeks approval for treating metastatic disease in patients who have failed prior chemotherapy (3/30) |
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Amgen Inc. (AMGN) |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Chemotherapy-induced anemia |
The FDA approved new every-three-week dosing schedule (3/27) |
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Celgene Corp. (CELG) |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Advanced multiple myeloma |
The FDA granted priority review to the sNDA seeking approval for treating relapsed or refractory MM; the PDUFA date is June 30 (3/3) |
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ChemGenex Pharmaceuticals Ltd. (Australia; CXSP) |
Ceflatoni |
sHHT; homoharringtonine; apoptosis inducer and angiogenesis inhibitor |
Chronic myeloid leukemia |
The FDA granted orphan designation to the drug in that indication (3/19) |
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Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB) |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and selectively depletes CD20-positive B cells |
Non-Hodgkin's lymphoma |
Filed supplemental BLA seeking approval as first-line treatment with chemotherapy in patients with low-grade or follicular, CD20-positive, B-cell NHL (3/30) |
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Genta Inc. (GNTA) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced chronic lymphocytic leukemia |
The FDA accepted for review NDA seeking approval of the drug with chemotherapy for treating refractory/relapsed disease; the PDUFA date is Oct. 28 (3/1) |
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ImClone Systems Inc. (IMCL) |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
The FDA approved second indication, for use with radiation therapy for treating advanced squamous cell carcinoma of the head and neck, and as a single agent in advanced disease not responsive to platinum-based treatment (3/1) |
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Pharmion Corp. (PHRM) |
Vidaza (FDA-approved) |
Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions |
Myelodysplastic syndromes |
Filed supplemental NDA with FDA seeking approval to allow for I.V. administration (3/30) |
SciClone Pharmaceuticals Inc. (SCLN) |
Zadaxin
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Synthetic preparation of thymosin alpha-1 |
Malignant melanoma |
The FDA granted orphan designation to the product for treating Stage IIb through IV disease (3/20) |
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CARDIOVASCULAR | ||||
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Cardiome Pharma Corp. (Canada; CRME) |
RSD1235 |
Intravenous formulation of drug designed to selectively block ion channels in the heart |
Atrial fibrillation |
Cardiome and partner Astellas Pharma US Inc. submited an NDA seeking approval to market the intravenous formulation (3/31) |
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Encysive Pharmaceuticals Inc. (ENCY) |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The FDA issued an approvable letter outlining various concerns; it called for additional clinical work (3/24) |
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Myogen Inc. (MYOG) |
Ambrisentan |
Oral endothelin receptor antagonist |
Pulmonary arterial hypertension |
The FDA granted fast-track status to the product in that indication, for which Phase III trials are on-going (3/9) |
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United Therapeutics Corp. (UTHR) |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
The FDA approved supplemental NDA based on Phase IV studies required under accelerated approval guidelines (3/21) |
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CENTRAL NERVOUS SYSTEM | ||||
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Avicena Group Inc. (OTC BB:AVGO) |
HD-02 |
Agent that incorporates ultra-pure form of creatine |
Huntington's disease |
The FDA granted orphan designation to the product in that indication (3/22) |
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Cephalon Inc. (CEPH) |
Sparlon |
New formulation and dosage of modafinil, the active ingredient in the approved product Provigil |
Attention deficit/hyperactivity disorder |
An FDA advisory committee recommended against approval, finding the drug was effective but saying more safety data were needed (3/23) |
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Medivation Inc. (OTC BB:MDVN) |
Dimebon |
Oral agent that's been used in Russia for more than 20 years |
Huntington's disease |
The FDA requested additional toxicology studies prior to the start of a proposed human clinical trial (3/1) |
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Nabi Bio-pharmaceuticals (NABI) |
NicVAX |
Nicotine conjugate vaccine |
Nicotine addiction |
The FDA granted fast-track designation for treating nicotine addiction (3/9) |
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Prestwick Pharmaceuticals Inc.* |
Xenazine (tetrabenazine) |
Dopamine depletor that works by selectively blocking the VMAT2 transporter |
Chorea associated with Huntington's disease |
The FDA issued an approvable letter that said certain undisclosed conditions must be met before it could be approved (3/31) |
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DIABETES | ||||
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Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
Filed supplemental NDA seeking approval as add-on therapy to thiazolidinediones in those not achieving acceptable blood sugar control (3/1) |
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INFECTION | ||||
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Cerexa Inc.* |
PPI-0903 |
Next-generation, broad-spectrum, cephalosporin antibiotic |
Complicated skin and skin structure infections |
The FDA granted fast-track status to the drug for treating cSSSIs caused by methicillin-resistant Staphylococcus aureus (3/14) |
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Cubist Pharmaceuticals Inc. (CBST) |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
S. aureus bacteremia and endocarditis |
The FDA issued an approvable letter on supplemental NDA; approval is subject to an agreement on labeling (3/24); submitted response to FDA (3/27) |
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Gilead Sciences Inc. (GILD) |
Viread and Truvada (both FDA-approved) |
Viread is a nucleotide reverse transcriptase inhibitor; Truvada combines Viread and Emtriva |
HIV |
The FDA granted traditional approval status to both products; accelerated approval for Viread was granted in October 2001 and for Truvada in August 2004 (3/8) |
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Medarex Inc. (MEDX) and PharmAthene Inc.* |
Valortim (MDX-1303) |
Fully human antibody that targets the Bacillus anthracis protective antigen |
Anthrax infection |
The FDA granted orphan designation to the product in that indication (3/6) |
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Transave Inc.* |
SLIT Amikacin |
Inhaled, sustained-release liposome formulation of amikacin |
Pseudomonas aeruginosa infections |
The FDA granted orphan designation to the product for treating bronchopulmonary P. aeruginosa infections in cystic fibrosis patients (3/23) |
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MISCELLANEOUS | ||||
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Aastrom Biosciences Inc. (ASTM) |
Tissue Repair Cells |
Autologous bone marrow-derived adult stem and progenitor cells |
Osteonecrosis |
The FDA granted orphan designation to the product in that indication, for which studies were being planned (3/23) |
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BioDelivery Sciences International Inc. (BDSI) |
Emezine |
Buccal tablet formulation of the approved agent prochlorperazine |
Severe nausea and vomiting |
The FDA issued non-approvable letter stating that additional information is needed (3/1) |
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NPS Pharmaceuticals Inc. (NPSP) |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
The FDA issued approvable letter that calls for additional clinical information on hypercalcemia,and on the injection device (3/10) |
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PTC Therapeutics Inc.* |
PTC124 |
Oral agent that targets nonsense mutations |
Duchenne muscular dystrophy |
The FDA granted fast-track designation to the product for treating DMD due to a nonsense mutation in the dystrophin gene (3/30) |
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Savient Pharmaceuticals Inc. (SVNT) |
Puricase |
Polyethylene glycol conjugate of uricase |
Gout |
Reached agreement with FDA on SPA for Phase III trials to test drug for controlling hyperuricemia in 200 nonresponding patients with symptomatic gout (3/21) |
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Notes: | ||||
* Privately held. | ||||
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. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange. |