Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
|
| ||||
AUTOIMMUNE | ||||
Aspreva Pharmaceuticals Corp. (Canada; ASPV) |
CellCept |
Mycophenolate mofetil; an immunosuppressant |
Lupus nephritis |
FDA granted fast-track designation (6/7) |
CANCER | ||||
Cel-Sci Corp. (AMEX:CVM) |
Multikine |
Immunotherapy product |
Squamous-cell carcinoma of the head and neck |
FDA granted orphan drug designation (6/12) |
Innovive Pharmaceuticals Inc. (OTC BB:IVPH) |
Tamibarotene |
A fully synethetic retinoid |
Relapsed or refractory acute promyelocytic leukemia |
FDA has granted a fast-track designation (6/7) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer HealthCare Pharmaceuticals Inc. |
Nexavar |
Sorafenib tablets |
Hepatocellular carcinoma |
Submitted an sNDA (6/27) |
Telik Inc. (TELK) |
Telcyta |
Canfosfamide HCl, TLK286 |
Ovarian cancer and non-small-cell lung cancer |
FDA initiated a clinical hold after Phase III data presented at ASCO; the data detailed the failures of the ASSIST-1, -2 and -3 trials (6/5); FDA converted the full clinical hold to a partial hold, allowing patients in ASSIST-3 and ASSIST-5 to continue receiving treatment (6/18) |
Xanthus Pharmaceuticals Inc.* |
Xanafide |
Amonafide malate; an ATP independent tropoisomerase 2 inhibitor |
Secondary acute myeloid leukemia |
FDA agreed to an SPA for a Phase III trial in combination with ara-C (6/12) |
CARDIOVASCULAR | ||||
Adolor Corp. (ADLR) |
Entereg |
A peripherally acting muopioid receptor antagonist; alvimopan |
Postoperative ileus |
FDA requested additional data be submitted as part of the complete response to the agency's November 2006 approvable letter (6/11) |
Encysive Pharmaceuticals Inc. (ENCY) |
Thelin |
Sitaxsentan sodium |
Pulmonary arterial hypertension |
Company received its third approvable letter (6/18) |
Gilead Sciences Inc. (GILD) |
Letairis |
Ambrisentan; an endothelin A receptor antagonist |
Pulmonary arterial hypertension |
FDA approved the product (6/18) |
Vasogen Inc. (Canada; VSGN) |
Celacade |
Immune-modulation therapy; delivers oxidative stress to a patient's cells |
Chronic heart failure |
FDA strongly recommended the company conduct a confirmatory trial to support a premarket approval filing (6/27) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. (CEPH) |
Nuvigil |
Armodafinil; longer-acting isomer of Provigil |
Sleepiness related to sleep apnea, shift work and narcolepsy |
FDA approved Nuvigil (6/18) |
Genzyme Corp. (GENZ) |
Synvisc-One |
A single treatment of Synvisc (hylan G-F 20); a viscosupplementation product |
Pain from osteoarthritis of the knee |
Filed with the FDA for approval (6/20) |
Labopharm Inc. (Canada; TSX:DDS) |
Tramadol |
Once-daily formulation; analgesic |
Pain |
Received a second approvable letter from the FDA, saying the company failed to demonstrate efficacy due to faulty statistical methodology (6/1) |
Neurocrine Biosciences Inc. (NBIX) |
Indiplon |
5-mg and 10-mg capsules of an immediate-release version |
Insomnia |
Resubmitted its NDA (6/13) |
INFECTION | ||||
Avant Immuno-therapeutics Inc. (AVAN) and GlaxoSmithKline Biologicals (a unit of GSK plc; UK) |
Rotarix |
A two-dose, live attenuated rotavirus vaccine |
Gastroenteritis caused by rotavirus |
Filed a marketing application with the FDA (6/27) |
Immtech Pharmaceuticals Inc. (AMEX:IMM) |
DB289 |
Pafuramidine |
Malaria |
FDA granted orphan drug designation (6/18) |
| ||||
Pfizer Inc. |
Marviroc |
A CCRF antagonist |
CCR5-tropic HIV-1 |
FDA issued an approvable letter (6/21) |
MISCELLANEOUS | ||||
Eurand Pharmaceuticals Ltd. (unit of Eurand NV; Italy; EURX) |
Zentase (formerly EUR-1008) |
A porcine-derived pancreatic enzyme product |
Exocrine pancreatic insufficiency |
Initiated the rolling submission of its NDA (6/12) |
Novalar Pharmaceuticals Inc.* |
NV-101 |
A local dental anesthetic reversal agent |
To restore normal sensation |
FDA has accepted for filing the NDA (6/19) |
| ||||
Novo Nordisk A/S (Denmark) |
Norditropin (FDA-approved) |
Somatropin (rDNA origin) injection |
Short stature in children with Noonan syndrome |
FDA approved Norditropin (6/1) |
Regeneron Pharmaceuticals Inc. (REGN) |
IL-1 Trap |
Interleukin-1 trap; rilonacept; attaches to IL-1 and neutralizes it in the blood stream before it can attach to cell-surface receptors and trigger disease activity |
Cryopyrin-associated periodic syndrome |
Regeneron completed a rolling biologics license application (6/8) |
|
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Notes: | ||||
* Privately held. ASCO = American Society of Clinical Oncology meeting. | ||||
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; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSX = Toronto Stock Exchange | ||||
