Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
| ||||
CANCER | ||||
| ||||
Cell Therapeutics Inc. (CTIC) |
Pixantrone |
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) |
Xyotax |
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) |
Provenge |
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) |
Zensana |
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) |
IL13-PE38QQR |
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) |
rNAPc2 |
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) |
EOquin |
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) |
| ||||
CARDIOVASCULAR | ||||
| ||||
Alexion Pharmaceuticals Inc. (ALXN) |
Soliris |
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) |
Tekturna |
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) |
rhThrombin |
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) |
| ||||
CENTRAL NERVOUS SYSTEM | ||||
| ||||
Endo Pharmaceuticals Holdings Inc. (ENDP) andVernalis 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) |
Trexima |
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) |
| ||||
INFECTION | ||||
| ||||
Advanced Life Sciences Holdings Inc. (ADLS) |
Cethromycin |
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 |
Pharyngitis/tonsillitis |
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 |
Influenza |
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) |
| ||||
MISCELLANEOUS | ||||
| ||||
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) |
Accretropin |
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) |
orBec |
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) |
Zelnorm |
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) |
Pennsaid |
A topical non-steroidal anti-inflammatory drug |
Osteoarthritis |
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) |
| ||||
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. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange |