Company* (Country; Symbol) | Product |
Description | Indication | Status (Date) |
|
| ||||
AUTOIMMUNE | ||||
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Chronic severe plaque psoriasis |
The FDA expanded label, approving drug to treat chronic severe plaque psoriasis in adults when other systemic therapies are medically less appropriate (9/27) |
CANCER | ||||
Abraxis BioScience Inc. (ABBI) |
Abraxane |
Paclitaxel protein-bound particles for injection; albumin-bound |
Breast cancer |
FDA advisory panel recommended against approval for use in the adjuvant treatment of node-positive breast cancer (9/7) |
Amgen Inc. (AMGN) |
Vectibix (panitumumab) |
Fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
The FDA approved the drug for treating EGFr-expressing metastatic colorectal cancer that progresses despite other treatments (9/27) |
Callisto Pharmaceuticals Inc. (AMEX:KAL) |
Atiprimod |
Small-molecule agent designed to inhibit VEGF and interleukin-6 |
Carcinoid tumors |
The FDA granted orphan designation to the product in that indication (9/26) |
Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB) |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and depletes CD20-positive B cells |
Non-Hodgkin's lymphoma |
The FDA approved two additional uses in patients with CD20-positive, B-cell NHL: for first-line treatment of previously untreated patients with follicular NHL in combination with CVP regimen, and for low-grade NHL in patients with stable disease or who have responded to CVP (9/29) |
Genentech Inc. (NYSE:DNA) |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Advanced breast cancer |
The FDA requested additional data from Phase III trial with paclitaxel; company plans to resubmit BLA in mid-2007 (9/11) |
Genta Inc. (GNTA) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced chronic lymphocytic leukemia |
FDA advisory panel voted against recommending approval of the product in that indication (9/5) |
Protherics plc (UK; LSE:PTI) |
Voraxaze |
Product containing the recombinant enzyme glucarpidase |
Toxicity from methotrexate |
Submitted BLA with FDA, seeking approval as an adjunctive therapy in those experiencing or at risk of toxicity from the cancer agent methotrexate (9/18) |
Threshold Pharmaceuticals Inc. (THLD) |
Glufosfamide |
Small molecule containing a glucose molecule and an alkylator |
Pancreatic cancer |
The FAD granted orphan designation to the drug in that indication, for which Phase II and III trials are ongoing (9/28) |
CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. (ALXN) |
Soliris (eculizumab) |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Submitted a BLA with the FDA, seeking approval for treating the rare genetic blood disorder (9/20) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. (CEPH) |
Fentora |
Fentanyl buccal tablet |
Pain |
The FDA approved the drug for managing breakthrough pain in cancer patients already receiving opioid therapy (9/25) |
Labopharm Inc. (Canada; TSX:DDS) |
-- |
Once-daily formulation of the analgesic tramadol |
Pain |
FDA issued approvable letter on NDA filed in November 2005; it was not clear if new trials would be needed (9/29) |
Vernalis plc (UK; VNLS) and Endo Pharmaceuticals Inc. (ENDP) |
Frova (FDA-approved) |
Frovatriptan; 5HT 1B/1D agonist |
Menstrually related migraine |
The FDA accepted for filing the supplemental NDA that was submitted in July (9/20) |
INFECTION | ||||
Oscient Pharmaceuticals Corp. (OSCI) |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Community-acquired pneumonia |
The FDA issued an approvable letter on supplemental NDA, asking for data clarification; company believes no new trials will be needed (9/22) |
Oscient Pharmaceuticals Corp. (OSCI) |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Acute bacterial sinusitis |
FDA panel recommended against approving supplemental NDA in that indication and said a study showing superiority was called for (9/12) |
MISCELLANEOUS | ||||
DOR BioPharma Inc. (AMEX:DOR) |
orBec |
Oral formulation of beclomethasone dipropionate; a corticosteroid |
Gastrointestinal graft-vs.-host disease |
Filed NDA with the FDA, seeking approval in that indication (9/22) |
Ortec International Inc. (OTC BB:ORTN) |
OrCel |
Collagen sponge seeded with allogeneic epidermal and dermal cells |
Epidermolysis bullosa |
FDA said humanitarian device exemption for use in hand reconstruction and donor sites in EB patients was approvable pending inspection of manufacturing facility (9/29) |
|
| ||||
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. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange. | ||||
To read more on related topics, click on one of the words below.