Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira |
Adalimumab; fully human antibody designed to block TNF-alpha |
Ankylosing spondylitis |
Filed supplemental BLA with the FDA, seeking approval in that indication (10/4) |
Abbott |
Humira (FDA- approved) |
Adalimumab; fully human antibody designed to block TNF- alpha |
Psoriatic arthritis and of active arthritis in PA and as a rheumatoid arthritis |
The FDA approved the drug for reducing the signs and symptoms first-line treatment for moderate to severe RA (10/4) |
Alba |
AT-1001 |
Oral zonulin receptor antagonist |
Celiac disease |
The FDA granted fast-track status to the drug in that indication (10/26) |
Genentech |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and selectively depletes CD20-positive B cells |
Rheumatoid arthritis |
The FDA accepted for review the supplemental BLA filed in August and designated it for priority review (10/31) |
CANCER | ||||
Celgene Corp. |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Myelodysplastic syndromes |
The FDA extended the PDUFA date by three months, to Jan 7, 2006; the NDA filing was completed in April (10/3) |
Genentech |
Rituxan |
Rituximab; antibody that targets and selectively depletes CD20-positive B cells |
Non-Hodgkin's lymphoma |
The FDA granted priority review to the BLA filed in August for previously untreated patients with intermediate or aggressive, CD20-positive, B-cell NHL in combination with chemotherapy (10/25) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
The FDA accepted for filing the supplemental BLA, and designated it for priority review (10/31) |
Savient |
Soltamox |
Tamoxifen oral liquid solution |
Breast cancer |
The FDA approved the product for treatment in adjuvant and metastatic settings and to reduce risks of breast cancer under certain conditions (10/31) |
SGX |
Troxatyl |
Troxacitabine; nucleoside analogue |
Acute myeloid leukemia |
The FDA granted fast-track designation to the product in the third- line treatment of AML in adults (10/19) |
Vion |
Cloretazine |
Sulfonylhydrazine DNA alkylating agent |
Acute myelogenous leukemia |
The FDA granted fast-track designation to the product for treating patients older than 60 with poor-risk AML (10/17) |
ZymoGenetics |
IL-21 |
Interleukin-21 |
Advanced melanoma |
The FDA granted orphan designation in that indication, for which Phase Ib trials are ongoing (10/5) |
CARDIOVASCULAR | ||||
Biopure |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Blood loss in trauma patients |
The FDA maintained hold on Naval Medical Research Center's proposed RESUS trial (10/19) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon |
Sparlon |
New formulation and dosage of modafinil, the active ingredient in the approved product Provigil |
Attention deficit/ hyperactivity disorder |
Received an approvable letter from the FDA on supplemental NDA filed in December 2004 (10/21) |
Pozen Inc. |
Trexima |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
NDA filed in August was accepted for review by the FDA (10/11) |
DIABETES | ||||
Nektar |
Exubera |
Dry-powder, inhaled insulin formulation that uses Nektar technology |
Type I and II diabetes |
The FDA told partners Sanofi- Aventis SA and Pfizer Inc. that it is extending the NDA review date to review additional chemistry data (10/30) |
MISCELLANEOUS | ||||
BioMarin |
Orapred ODT |
Prednisolone sodium phosphate tablets; new formulation of Orapred |
Inflammation reduction |
The FDA accepted for filing the NDA for Orapred; the NDA was filed in August; the PDUFA date is June 1, 2006 (10/19) |
CollaGenex |
Oracea |
Non-antimicrobial tetracycline derivative |
Rosacea |
The FDA accepted for review the NDA, which was filed in August (10/3) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Broncho- pulmonary dysplasia |
The FDA granted orphan designation to the product in that indication, also known as chronic lung disease, in premature infants (10/28) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
The FDA accepted resubmission by Discovery as a complete response to the approvable letter; completion of the NDA review is expected by April 2006 (10/21) |
Insmed Inc. |
iPlex (SomatoKine) |
Composition of insulin- like growth factor-1 and its primary binding protein BP3 |
Severe primary IGF-1 deficiency |
Response to FDA approvable letter was deemed complete; review is expected by Dec. 12 (10/25) |
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. NYSE = New York Stock Exchange. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
