Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
The FDA, which had issued an approvable letter in October calling for more trials, said the drug was unlikely to gain accelerated approval (3/14) |
CANCER | ||||
Advanced |
Combidex |
Molecular imaging agent |
Cancer diagnosis |
An FDA advisory panel voted 15-4 against recommending approval for differentiating metastatic from non-metastatic lymph nodes across all cancer types (3/3) |
Gamida-Cell |
StemEx |
Ex vivo expanded cord blood stem/progenitor cells with non- expanded cells from the same unit |
Advanced hematologic malignancies |
The FDA granted orphan designation to the product for use as hematopoietic support in patients receiving high-dose therapy (3/15) |
Genta Inc. |
LR3001 |
Antisense compound directed against the oncogene c-myb |
Chronic myelocytic leukemia |
The FDA designated orphan status to the drug, which has been tested in two Phase I trials (3/15) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Multiple myeloma |
The FDA approved supplemental NDA to include the treatment of patients who have received at least one prior therapy (3/25) |
CARDIOVASCULAR | ||||
Inotek |
INO-1001 |
Inhibitor of the nuclear cell death enzyme poly (ADP- ribose) polymerase |
Aortic aneurysm repair |
Reached agreement with FDA on SPA for pivotal trial for reducing complications associated with thoracoabdominal aortic aneurysm repair surgery (3/3) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon |
Nuvigil |
Armodafinil; single isomer of the active ingredient in Provigil (modafinil) |
Excessive sleepiness |
Filed NDA with FDA seeking approval for improving wakefulness associated with narcolepsy, shift-work sleep disorder and obstructive sleep apnea/hypopnea syndrome (3/31) |
Cephalon |
Actiq (FDA-approved) |
Oral transmucosal fentanyl citrate; sugar-free formulation |
Pain in cancer patients |
The FDA issued an approvable letter on the new formulation; Cephalon said it expects a 3Q:05 approval (3/25) |
Orphan |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Narcolepsy |
The FDA accepted the supplemental NDA filing; the review deadline is Nov. 18, 2005 (3/21) |
DIABETES | ||||
Amylin |
Symlin |
Pramlintide acetate; an analogue of human amylin |
Types I and II diabetes |
The FDA approved the drug for use with insulin in patients who failed to achieve desired glucose control with insulin (3/16) |
Depomed Inc. |
Glumetza |
Once-daily, extended- |
Type II diabetes |
The FDA issued an approvable letter saying the drug is approvable pending the completion of discussions related to one manufacturing specification (3/1) |
Keryx Bio- |
KRX-101 |
Sulodexidel; oral heparinoid compound |
Diabetic nephropathy |
Finalized SPA with the FDA on Phase III and IV trials; a single Phase III trial will be run in patients with microalbuminuria (3/16) |
INFECTION | ||||
ID Biomedical |
Fluviral |
Influenza vaccine |
Influenza |
The FDA said the product is eligible for accelerated approval and priority review, meaning it is possible it could be licensed for the 2006-07 season (3/15) |
Theravance |
Telavancin |
Lipoglycopeptide antibiotic believed to have multiple mechanisms of action |
Hospital- acquired pneumonia and complicated skin and skin-structure infections |
The FDA granted fast-track designation to the Phase III drug in HAP and complicated skin and complicated skin and skin-structure infections (3/28) |
MISCELLANEOUS | ||||
Halozyme |
Enhanze SC |
Formulation of recombinant human hyaluronidase |
For use as a spreading agent |
The company filed an NDA with the FDA (3/28) |
Insmed Inc. |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Growth hormone insensitivity syndrome |
The FDA accepted for review the NDA on the orphan drug, which was filed in January (3/10) |
ISTA |
Xibrom |
Bromfenac sodium solution; topical non-steroidal anti-inflammatory agent |
Ocular inflammation following cataract surgery |
The FDA approved the product; launch is expected in the second quarter (3/28) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations |
Cystic fibrosis |
The FDA granted fast-track designation to the product in that indication (3/31) |
| | ||||
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; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange. | ||||
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