Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Aspreva |
CellCept |
Mycophenolate mofetil; an immunosuppressant |
Myasthenia gravis |
The FDA granted orphan designation to the product in that indication, for which Phase III trials are ongoing (1/3) |
Genelabs |
Prestara |
Prasterone; synthetic equivalent of dehydro- epiandrosterone |
Lupus |
The FDA said an additional Phase III trial would be needed to support approval for treating signs and symptoms of lupus; Genelabs plans to conduct a trial; it is ending development for preventing loss of bone mineral density in lupus patients, however, after the FDA said another trial also would be needed in that indication (1/13) |
CANCER | ||||
Favrille Inc. |
FavId |
Patient-specific vaccine designed to stimulate immune responses |
B-cell follicular non-Hodgkin's lymphoma |
The FDA granted fast-track status in that indication, for which a pivotal trial is ongoing (1/12) |
Genmab A/S |
HuMax-GFr |
Fully human antibody that targets the epidermal growth factor receptor |
Reftractory head and neck cancer |
The FDA granted fast-track status to the product in that indication (1/3) |
CARDIOVASCULAR | ||||
CV |
Ranexa(ranolazine) |
Partial inhibitor of fatty-acid oxidation |
Chronic angina |
The FDA approved the drug for treating chronic angina (1/27) |
Nuvelo Inc. |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Acute peripheral arterial occlusion |
The FDA granted the drug fast- track designation in that indication, for which Phase III trials are ongoing (1/23) |
CENTRAL NERVOUS SYSTEM | ||||
Adolor |
ADL5859 |
Oral compound that targets the Delta opioid receptor |
Pain |
The FDA placed a hold on a proposed Phase I trial pending additional preclinical safety studies and other information (1/30) |
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Pseudobulbar affect |
Completed NDA submission seeking approval in that indication, which also is know as involuntary emotional expression disorder or emotional lability (1/30) |
New River |
NRP104 |
Prodrug of amphetamine |
Attention deficit/ hyperactivity disorder |
The FDA accepted for review the NDA filing, which was made in December 2005 (1/27) |
TheraQuest |
TQ-1018 |
High-concentration, topical Capsaicin |
Postherpetic neuralgia |
The FDA granted orphan designation to the product in that indication (1/31) |
DIABETES | ||||
Nektar |
Exubera |
Dry-powder, inhaled insulin formulation that uses Nektar technology |
Type I and II diabetes |
The FDA granted marketing approval to Exubera, which will be marketed in the U.S. by Pfizer (1/27) |
INFECTION | ||||
Acambis plc |
ACAM2000 |
Second-generation vaccine |
Smallpox infection |
Submitted first portion of a BLA under a rolling application (1/18) |
BioCryst |
Peramivir |
Influenza neuraminidase inhibitor |
Influenza |
The FDA granted fast-track status to the drug for treating influenza infections, including highly virulent, life-threatening strains (1/17) |
Cangene Corp. |
VariZIG |
Varicella immune globulin |
Varicella zoster exposure |
The FDA approved an expanded access program under which at- risk patients can receive VariZIG if exposed to the virus, which causes chickenpox (1/31) |
Cangene Corp. |
HepaGam B |
Hepatitis B immune globulin (human) |
Exposure to hepatitis B virus |
The FDA approved the product for treatment following acute exposure to hepatitis B virus (1/30) |
Idenix |
Telbivudine |
Selective, oral nucleoside analogue |
Hepatitis B |
They filed an NDA with the FDA seeking approval for treatment of chronic hepatitis B (1/3) |
Medarex Inc. |
Valortim (MDX-1303) |
Fully human antibody that targets the Bacillus anthracis protective antigen |
Anthrax infection |
The FDA granted fast-track designation to the product, which is in Phase I trials (1/9) |
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Acute bacterial sinusitis and community- acquired pneumonia |
The FDA accepted for review supplemental NDA in CAP but refused to accept the sNDA for treating ABS, citing an unacceptable risk- benefit profile (1/20) |
Replidyne |
Orapem |
Ester, oral produg formulation of faropenem, an agent from the penem class |
Multiple conditions |
Replidyne filed an NDA seeking approval for acute bacterial sinusitis, community-acquired pneu- monia, acute exacerbations of bronchitis and uncomplicated skin and skin-structure infections (1/9) |
Starpharma |
VivaGel |
Vaginal microbicide gel |
HIV prevention |
The FDA granted fast-track status to the product (1/9) |
MISCELLANEOUS | ||||
BioMarin |
Phenoptin |
Sapropterin hydrochloride; form of the enzyme co-factor 6R-BH4 |
Phenylketonuria |
The FDA granted fast-track designation to the product in that indication, for which Phase III trials are ongoing (1/25) |
CepTor Corp. |
Myodur (C101) |
Muscle cell-targeted product designed to inhibit calpain |
Duchenne and Becker muscular dystrophies |
The FDA granted orphan designation to the drug in both indications (1/25) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Broncho- pulmonary dysplasia |
The FDA granted fast-track designation to the drug in BPD (also known as chronic lung disease) in premature infants (1/26) |
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Pompe disease |
The FDA extended by 90 days its review period on the BLA; the new action date is April 28, 2006 (1/17) |
Sucampo |
Amitiza |
Lubiprostone capsules; selective chloride channel activator |
Chronic idiopathic constipation |
The FDA approved the product, which will be jointly marketed with Takeda Pharmaceuticals America Inc. (1/31) |
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; CSE = Copenhagen Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
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