Company* (Symbol)




Status (Date)


Celgene Corp. (CELG)


Thalidomide; modulates levels of tumor necrosis factor-alpha

Multiple myeloma

FDA said the company has to conduct a new trial in a different indication; the company will now pursue seeking approval of Thalomid in early stage multiple myeloma, instead of refractory/relapsed multiple myeloma (3/7)

Corixa Corp. (CRXA)


Tositumomab, iodine-131; radioimmuno-

Non-Hodgkin's lymphoma

FDA said the company failed to provide sufficient evidence of safety and clinical benefit in its BLA (3/13)

Guilford Pharm-
Inc. (GLFD)

Gliadel Wafer (FDA-

Biodegradable polyanhydride polymer wafer implant containing carmustine

Malignant glioma

FDA issued a non-approvable letter rejecting a supplemental NDA for use of the Gliadel Wafer in patients with newly diagnosed malignant glioma (3/20)


Serono SA

Rebif (FDA-

Interferon beta 1-a

Multiple sclerosis

FDA approved Rebif (3/8)


Cubist Pharma-
Inc. (CBST)


Daptomycin for injection

Complicated skin and soft tissue infections

Company plans to submit an NDA before the year's end after FDA indicated it would be accepted for filing as proposed (3/7)

Gilead Sciences Inc. (GILD)

Adefovir dipivoxil

Nucleotide analogue that works by blocking the hepatitis B virus DNA polymerase

Hepatitis B

Company filed an NDA (3/22)

ViroPharma Inc. (VPHM)


Pleconaril; oral antiviral product that inhibits the function of the picornavirus capsid

Viral respiratory infection

An FDA advisory committee recommended against approval (3/19)


Centocor Inc. (unit of Johnson and Johnson)

Remicade (FDA-

Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood

Crohn's disease

FDA granted priority review status for Remicade as a monotherapy for inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease (3/21)

Corus Pharma Inc.*

Corus 1020 of patients with cystic fibrosis

Inhalation therapy; antibiotic with activity against Gram-negative bacteria

Gram-negative bacteria in the respiratory tract

Corus 1020 was granted orphan drug designation by the FDA (3/20)

Elan Corp. plc (Ireland) and Ligand Pharmaceuticals Inc. (LGND)

Avinza (FDA-

Once-daily treatment; morphine sulfate extended-release

Chronic, moderate to severe pain

Companies received U.S. regulatory approval for Avinza (3/21)

InKine Pharmaceutical Co. Inc. (INKP)

Visicol (FDA-

Tablet form; sodium phosphate

Bowel cleansing prior to colonoscopy

FDA approved the supplemental NDA for a new formulation of Visicol tablets; the new, smaller Visicol tablet contains significantly less microcrystalline cellulose than the current formulation (3/14)

Orthologic Corp. (OLGC)


Synthetically manufactured peptide

Spinal fusion

FDA gave the company authorization to begin a combined I/II trial of Chrysalin; the trial will include about 300 patients (3/8)

SangStat Medical Corp. (SANG)

Thymoglobulin (FDA-

Anti-thymocyte globulin, rabbit; organ rejection therapeutic

Kidney transplant rejections

An independent Data Safety and Monitoring Board decided to close the company's comparative kidney transplant study early after an interim analysis revealed significantly fewer acute rejections in patients treated with Thymoglobulin vs. Novartis AG's Simulect (3/12)

Sepracor Inc. (SEPR)


Tecastemizole 15-mg and 30-mg capsules; active metabolite; nonsedating antihistamine; norastemizole

Allergic rhinitis

FDA said it will issue a not-approvable letter due to safety studies in animals that were not observed in humans, and other concerns (2/7)


* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

NYSE = New York Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application