Company*
(Country;
Symbol)
Product Description Indication Status (Date)

AUTOIMMUNE
Abbott
Laboratories
(NYSE:ABT)
Humira (FDA-approved)Adalimumab; fully human antibody designed to block TNF- alphaModerately to severely active Crohn's diseaseFDA approved Humira as a treatment for reducing the signs and symptoms, and inducing and maintaining clinical remission in adults who have had an inadequate response to conventional therapy (2/27)
CANCER
Pfizer Inc.
(NYSE:PFE)
Sutent (FDA-approved) Sunitinib malate; a multiple-receptor tyrosine kinase inhibitorAdvanced renal cell carcinomaFDA approved new labeling to include first-line treatment (2/8)
Pharmacyclics
Inc.
(PCYC)
XcytrinMotexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosisBrain metastases due to non-small-cell lung cancerFDA rejected the NDA because the trials did not demonstrate statistically significant differences between treatment arms in the prespecified endpoints (2/21)
Pro-
Pharmaceuticals
Inc.
(AMEX:PRW)
DavanetA carbohydrate polymer, composed of mannose and galactose (galactomannan)CancerBegan filing NDA as a treatment in combination with 5-fluorouracil (2/7)
Seattle Genetics
Inc.
(SGEN)
SGN-33Lintuzumab; a humanized monoclonal antibody targeting CD33Acute myeloid leukemiaFDA granted orphan drug designation (2/13)
Spectrum
Pharmaceuticals
Inc.
(SPPI) and
GPC Biotech AG
(Germany; GPCB)
SatraplatinOral platinum compound Prostate cancerGPC completed its submission of the rolling NDA (2/19)
CARDIOVASCULAR
Aastrom
Biosciences
Inc.
(ASTM)
Tissue Repair CellsConsist of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient Dilated cardiomyopathyFDA granted orphan drug designation (2/1)
Cardiome Pharma
Corp.
(Canada;
CRME) and Astellas
Pharma US Inc.
Vernakalant hydrochlorideIntravenous formulationFor the acute conversion of atrial fibrillationFDA accepted for review the NDA (2/20)
EPIX
Pharmaceuticals
(EPIX)
VasovistBlood-pool imaging agentTo visualize vascular diseaseEPIX filed a formal appeal with the FDA seeking approval of Vasovist, following three denials by the agency (2/28)
Gilead Sciences
Inc.
(GILD)
AmbrisentanOnce-daily treatment Pulmonary arterial hypertensionFDA granted priority review for the NDA (2/20)
ZymoGenetics
Inc.
(ZGEN)
rhThrombinRecombinant human thrombin Hemostasis during surgeryFDA accepted for review the BLA (2/19)
CENTRAL NERVOUS SYSTEM
New River
Pharmaceuticals
Inc.
(NRPH) and
Shire plc (UK)
VyvanseOnce-daily treatment that consists of d-amphetamine, covalently linked to l- ysine, a naturally occurring amino acid that is quickly absorbed from the gastrointestinal tract and converted to d-amphetamineAttention deficit hyperactivity disorderFDA approved Vyvanse (2/26)
INFECTION
Advancis
Pharmaceutical
Corp.
(AVNC)
Amoxicillin PULSYSAmoxicillin formulation delivered with once-daily pulsatile Pulsys technologyPharyngitisCompany received a refusal to file letter from the FDA for the once-daily NDA; the application did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls (2/14)
Emergent
BioSolutions
Inc.
(NYSE:EBS)
BioThraxAnthrax vaccine absorbedPostexposure prophylaxis against anthrax infectionFDA granted fast-track designation (2/12)
Theravance Inc.
(THRX)
TevavancinLipoglycopeptide; bactericidal injectable antibioticComplicated skin and skin structure infections caused by Gram-positive organismsFDA accepted the NDA (2/21)
ViroPharma
Inc.
(VPHM)
MaribavirBenzimidazole compound; oral inhibitor of cytomegalovirusTo prevent cytomegalovirus viremiaReceived orphan drug designation from the FDA (2/7)
MISCELLANEOUS
BioMimetic
Therapeutics
Inc.
(BMTI)
rhPDGF-BBRecombinant human platelet derived growth factorOsteonecrosis of the jawFDA designated rhPDGF-BB an orphan drug (2/21)
Hana
Biosciences
Inc.
(HNAB)
ZensanaAn oral spray formulation of the 5-HT3 antagonist ondansetronTo prevent nausea and vomiting as a result of chemotherapyFDA approval will likely be delayed because stability studies detected small amounts of precipitated material in scale-up batches of Zensana (2/21)
Kuros
Biosurgery AG
(Switzerland)
I-040302Bone-repair productSolitary bone cystsFDA granted orphan drug designation (2/22)
Ortec
International
Inc.
(OTC BB:
OTCI)
OrCelTissue-engineered productVenous leg ulcers Filed a pre-market approval supplement application (2/26)

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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board

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