Company* (Country; Symbol)




Status (Date)


Cell Therapeutics Inc. (CTIC)


Anthracycline agent designed to have improved properties

Indolent non-Hodgkin's lymphoma

Filed SPA with the FDA for design of Phase III PIX303 trial, which is expected to test the drug in a combination regimen in 300 patients (3/13)

Cell Therapeutics Inc. (CTIC)


Paclitaxel poliglumex

Non-small-cell lung cancer

Filed SPA with the FDA for a Phase III trial comparing the combination of Xyotax and carboplatin to paclitaxel and carboplatin (3/20)

Dendreon Corp. (DNDN)


Sipuleucel T; active cellular immunotherapy

Prostate cancer

FDA advisory committee voted favorably, 13-4, that there is substantial evidence of efficacy (3/29)

Hana Biosciences Inc. (HNAB)


Ondansetron HCl; oral spray

To prevent nausea and vomiting associated with chemotherapy, radiation and surgery

Withdrew an NDA due to a manufacturing issue (3/23)

NeoPharm Inc. (NEOL)


Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38

Recurrent glioblastoma multiforme

The FDA's Office of Oncology wants another Phase III trial before considering approval of the drug (3/29)

Nuvelo Inc. (NUVO)


A recombinant protein designed to interfere with the tissue factor/factor VIIa/factor Xa protease complex

First- and second-line treatment of metastatic colorectal cancer

FDA granted fast-track designations of rNAPc2 to improve progression-free survival and overall survival when added to Avastin-containing 5-fluorouracil-based regimens in first-line, and when combined with 5-FU-based chemotherapy for second-line (3/27)

Spectrum Pharmaceutical Inc. (SPPI)


Apaziquone for intravesical instillation; activated by reductase enzymes found in cancer cells

Non-invasive bladder cancer

Reached agreement with FDA on the pivotal trial design, which will evaluate tumor recurrence after two years in two 562-patient trials (3/13)


Alexion Pharmaceuticals Inc. (ALXN)


Eculizumab; monoclonal antibody designed to selectively block terminal complement activation

Paroxysmal nocturnal hemoglobinuria

The FDA approved the product for treating PNH patients to reduce hemolysis; PNH is a rare, disabling blood disorder (3/16)

Omrix Bio-pharmaceuticals Inc. (OMRI)

Evicel (FDA-approved)

A second-generation liquid fibrin sealant

General hemostasis in surgery

Submitted a sBLA for the expanded label (3/8)

Speedel Group (Switzerland; SWX:SPPN) and Novartis AG (Switzerland)


Aliskiren; once daily oral tablet

High blood pressure

FDA approved Tekturna for use as a monotherapy and with other anti-hypertensives (3/6)

ZymoGenetics Inc. (ZGEN)


Recombinant human thrombin administered by a spray device

To control bleeding during surgery

FDA will not require additional trials, shortening the development timeline by about 18 months; the spray would follow approval of the company's BLA for rhThrombin (3/7)


Endo Pharmaceuticals Holdings Inc. (ENDP) and Vernalis plc (UK; LSE:VER)

Frova (FDA-approved)

Frovatriptan; 5HT 1B/1D agonist

Menstrually related migraine

The FDA said it would need three more months to review supplemental NDA that was filed in August; no new data are needed; the review is expected to be completed by Aug. 19 (3/16)

Pozen Inc. (POZN)


Combination of sumatriptan succinate and naproxen sodium in a single tablet

Acute migraine

FDA accepted for review the amended response to an approvable letter (3/23)

Valeant Pharmaceuticals Inc. (NYSE:VRX)

Permax (FDA-approved)

Pergolide; dopamine agonist

Parkinson's disease

Company withdrew Permax from the market because it can seriously damage heart valves (3/29)


Advanced Life Sciences Holdings Inc. (ADLS)


Second-generation ketolide antibiotic

Anthrax infection

The FDA granted orphan designation to the product for the prophylactic treatment of patients exposed to inhalation anthrax (3/14)

Advancis Pharmaceutical Corp. (AVNC)

Amoxicillin Pulsys

Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology


Resubmitted its NDA for a once-daily product for treating adolescents and adults; this follows a refusal-to-file letter from the FDA in February, requesting more information on commercial manufacturing processes (3/23)

Gilead Sciences Inc. (GILD) and F. Hoffmann-La Roche Ltd. (Switzerland)

Tamiflu (FDA-approved)

Oseltamivir phosphate


Roche filed an sNDA to market 30-mg and 45-mg pediatric doses of Tamiflu, which is currently available in a 75-mg capsule for adults and a liquid suspension formulation for children (3/9)


Amgen Inc. (AMGN)

Aranesp and Epogen (both FDA-approved)

Red-blood cell boosters; ertyhropoietin products

Anemia in chronic kidney failure and cancer

FDA is requiring a new black box warning on the labels letting patients know of death risks plus chances of cardiovascular events and tumor growth when used off-label (3/9)

Cangene Corp. (Canada; TSX:CNJ)


A recombinant human growth hormone product

Growth failure in children with growth hormone deficiency and short stature associated with Turner syndrome

Received an approvable letter from the FDA, which requested additional support data regarding manufacturing processes (3/12)

DOR BioPharma Inc. (OTC BB:DORB)


Oral formulation of beclomethasone dipropionate

To prevent graft-vs.-host disease

Received clearance from the FDA to conduct a Phase II trial with 138 patients (3/26)

Insmed Inc. (INSM)

Iplex (FDA-approved)

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Short stature

The settlement of a patent fight with Tercica Inc. resulted in the removal of Iplex from the market, clearing the path for Tercica's drug Increlex; Insmed also is withdrawing its Iplex marketing application in Europe (3/7)

Novartis AG (Switzerland)


Tegaserod maleate

Irritable bowel syndrome with constipation and chronic constipation

Novartis agreed to an FDA request to remove it from the market due to an increased risk of serious cardio-vascular adverse events associated with the drug (3/30)

Nuvo Research Inc. (Canada; TSX:NRI)


A topical non-steroidal anti-inflammatory drug


Company learned after an FDA meeting that an additional Phase III is not needed to satisfy questions in an approvable letter; the company expects to file a response in the fourth quarter (3/8)

Progenics Pharmaceuticals Inc. (PGNX) and Wyeth Pharmaceuticals

MNTX receptors

Methylnaltrexone; agent designed to block peripheral opioid

Opioid-induced constipation

Progenics and Wyeth filed an NDA for a subcutaneous version (3/30)


* 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.

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