Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab |
Psoriatic arthritis |
FDA approved an expanded label that includes inhibiting structural joint damage and improving physical function (11/14) |
Immunomedics |
Epratuzumab |
Humanized anti-CD20 monoclonal antibody |
Lupus |
FDA lifted the clinical hold placed in September after UCB voluntarily suspended Phase III dosing following a routine quality-assurance audit (11/14) |
NicOx SA |
Naproxcinod |
COX-inhibiting nitric oxide- donating compound |
Osteoarthritis |
FDA said a large clinical cardiovascular outcomes study would not be required at the time of the NDA submission (11/10) |
CANCER | ||||
ChemGenex |
Ceflatonin |
Homoharringtonine |
Chronic myeloid leukemia |
Awarded fast-track status by FDA for chronic, accelerated and blast- phase CML in those who have failed Gleevac and have the T315I bcr-abl point mutation (11/15) |
Dendreon Corp. |
Provenge |
Sipuleucel-T |
Prostate cancer |
Submitted the final portion of its rolling BLA (11/13) |
Morphotek Inc.* |
MORAb-009 |
Fully human monoclonal antibody made by Morphodoma |
Pancreatic cancer |
Received orphan drug designation from FDA (11/7) |
Progen |
PI-88 |
Anti-angiogenesis drug designed to inhibit tumor- promoting factors |
Cancer |
FDA notified the company it can start Phase III trials (11/29) |
Protherics plc |
Voraxaze |
Product containing the recombinant enzyme glucarpidase |
Cancer |
Company withdrew the BLA submitted in October for Voraxaze as an adjunctive therapy for cancer patients experiencing, or at risk of, toxicity from methotrexate, after the FDA requested additional manufacturing data (11/7) |
Synta |
STA-4783 |
Small molecule |
Metastatic melanoma |
Received fast-track status by the FDA (11/15) |
CARDIOVASCULAR | ||||
Adolor Corp. |
Entereg |
Alvimopan |
Postoperative ileus |
FDA delayed approving Entereg pending additional safety data (11/6) |
Alexion |
Soliris |
Eculizumab |
Paroxysmal nocturnal hemoglobinuria |
FDA accepted the BLA and will give Soliris priority review (11/14) |
Encysive |
Thelin |
Sitaxsentan sodium |
Pulmonary arterial hypertension |
Submitted complete response to the FDA approvable letter received July 24 (11/3) |
NovaDel |
NitroMist |
Nitroglycerin lingual aerosol |
Angina pectoris due to coronary artery disease |
FDA approved NitroMist (11/3) |
Omrix Bio- |
-- |
Thrombin |
General hemostasis in surgery |
Submitted a BLA (11/6) |
Protalex Inc. |
PRTX-100 |
Bioregulatory compound designed to normalize the activity of immune cells |
Idiopathic thrombocytopenia purpura |
FDA showed concern over data on certain subjects that participated in the Phase I study (11/10) |
CENTRAL NERVOUS SYSTEM | ||||
Pozen Inc. |
Trexima |
Sumatriptan/naproxen; formulated with RT Technology |
Migraine |
Company filed a full response to the FDA's approvable letter (11/9) |
INFECTION | ||||
Cangene Corp. |
VariZIG |
Varicella zoster immune globulin |
Varicella |
FDA granted orphan drug designation (11/10) |
Immtech |
DB289 |
Pafuramidine |
Pneumocystis jiroveci pneumonia |
FDA granted orphan drug status (11/21) |
Oscient |
Factive |
Gemifloxacin mesylate tablets |
Community-acquired pneumonia |
FDA accepted the company's complete response to the approvable letter for the five-day treatment of the infection (11/27) |
VaxGen Inc. |
rPA102 |
Anthrax vaccine |
Anthrax |
FDA placed program on hold, delaying a second Phase II trial (11/3); Department of Health and Human Services extended to Dec. 18 the deadline by which the company must resolve the clinical hold; the company responded to the FDA Nov. 13 (11/16) |
Virax Holdings |
VIR201 |
Vaccine designed to stimulate the immune system |
HIV/AIDS |
FDA allowed an IND application for Phase II testing (11/17) |
MISCELLANEOUS | ||||
DOR BioPharma |
orBec |
Oral beclomethasone dipropionate |
Gastrointestinal graft-vs.-host disease |
FDA accepted its NDA (11/21) |
Pharmaxis Ltd. |
Bronchitol |
Mannitol formulation delivered via an inhalation device |
Cystic fibrosis |
FDA designated Bronchitol as a fast-track product (11/27) |
Repligen |
RG1068 |
Synthetic human secretin |
To improve detection of abnormalities of the pancreatic ducts |
FDa granted orphan drug designation (11/21) |
Tercica Inc. |
Somatuline Autogel |
Lanreotide acetate injection |
Acromegaly |
Submitted an NDA for the 60 mg, 90 mg and 120 mg dosages (11/2) |
ThromboGenics |
-- |
Microplasmin; intraocular injection |
Back-of-the-eye diseases |
FDA completed its review of the investigational new drug application, and the company will start enrollment (11/13) |
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; 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 | ||||
