Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Acorda |
Fampridine-SR |
Selective neuronal potassium channel blocker |
Multiple sclerosis |
Phase III trial run under FDA SPA demonstrated statistical significance on all three efficacy criteria, which related to walking capabilities (9/25) |
Alba |
AT-1001 |
Oral zonulin receptor antagonist |
Celiac disease |
Began Phase II trial to evaluate safety, tolerability and efficacy in 79 patients during gluten challenge (9/21) |
Biogen Idec |
Tysabri (FDA-approved) |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
Phase III AFFIRM trial demonstrated monotherapy treatment significantly reduced the proportion of patients with worsening cognitive function (9/28) |
Genzyme |
Campath (FDA-approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
Multiple sclerosis |
Interim two-year data from Phase II trial showed favorable results vs. Rebif; Campath treatment in the study remained on hold while adverse events were investigated (9/14) |
Immunomedics |
Epratuzumab |
Humanized anti-CD20 monoclonal antibody |
Lupus |
Partner UCB SA suspended dosing in Phase II trial due to a concern in the manufacturing process; the FDA placed a clinical hold on the study (9/26) |
Opexa |
Tovaxin |
Trivalent formulation of attenuated myelin-peptide reactive T cells |
Multiple sclerosis |
Phase I/II trial showed a relapse rate reduction of more than 90% after 12 months; is starting Phase IIb trial in 150 patients (9/18) |
Rigel |
R788 |
Oral syk kinase inhibitor |
Rheumatoid arthritis |
Began Phase II trial to evaluate responses in 180 patients who have active disease despite taking methotrexate (9/6) |
Trubion |
TRU-015 |
Immunotherapeutic agent |
Rheumatoid arthritis |
Began Phase IIb trial to evaluate safety and efficacy of a single infusion in 280 patients (9/27) |
CANCER | ||||
AmpliMed |
Amplimexon |
Imexon injection; a cyanoaziridine compound |
Advanced malignant melanoma |
Data from 27 patients in Phase I/II trial of drug with dacarbazine showed five partial responses and seven patients with stable disease (9/14) |
Antisoma plc |
AS1404 |
Small molecule derived from xanthenone acetic acid; vascular disrupting agent |
Hormone- refractory prostate cancer |
Data from 64 patients in Phase II trial showed a PSA response rate of 57% for drug plus docetaxel vs. 35% for docetaxel alone; also, disease progression by PSA was 17% in drug group vs. 29% with docetaxel alone (9/18) |
Biothera* |
Imprime PGG |
Injectable beta 1,3/1,6 glucan derived from yeast; immunotherapy |
Cancers |
Phase I trial in healthy volunteers demonstrated safety and tolerability over three doses (9/25) |
ChemGenex |
Ceflatonin |
sHHT; homoharringtonine; apoptosis inducer |
Chronic myeloid leukemia |
Began Phase II/III trial to evaluate response rates in up to 81 patients who have the T315I bcr-abl point mutation (9/20) |
Cytogen |
Quadramet (FDA-approved) |
Samarium-153 bound to a small-molecule, bone- seeking phosphonate |
Bone metastases from prostate cancer |
Study in 13 patients demonstrated improved pain intensity on movement (9/19) |
EntreMed |
MKC-1 |
Small-molecule cell-cycle inhibitor |
Advanced leukemias |
Began a Phase I trial in that indication (9/26) |
EntreMed |
Panzem NCD |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Hormone- |
Began Phase II trial to evaluate antitumor activity, safety and pharmacokinetics in patients (9/12) |
Gemin X |
GX15-070 |
Small-molecule inhibitor of bcl-2 proteins |
Hodgkin's lymphoma |
Began single-agent Phase II trial to evaluate efficacy, safety and pharmacokinetics in 10 to 29 patients (9/14) |
Gemin X |
GX15-070 |
Small-molecule inhibitor of bcl-2 proteins |
Myelofibrosis with myeloid metaplasia |
Began single-agent Phase II trial to evaluate efficacy, safety and pharmacokinetics in 19 to 55 patients (9/14) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced melanoma |
Long-term follow-up data from Phase III trial in 771 patients showed benefit of drug with dacarbazine in all endpoints vs. dacarbazine alone (9/15) |
Genzyme |
Clolar (FDA-approved) |
Clofarabine; second- generation purine nucleoside analogue |
Acute myelogenous leukemia |
Began pivotal Phase III trial to evaluate safety and efficacy with cytarabine in up to 376 patients 60 years old and older (9/6) |
Gloucester |
Depsipeptide (FK228) |
Romidepsin; histone deacetylase inhibitor |
Pancreatic cancer and other tumors |
Began open-label Phase I/II trial to evaluate dosing with gemcitabine in 30 patients (9/12) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Hormone- refractory prostatecancer |
Pivotal Phase III SPARC trial in 950 second-line patients demonstrated statistical significance vs. placebo on progression-free survival; agent and placebo were tested with prednisone (9/24) |
GTx Inc. |
Acapodene |
Toremifene citrate; small- molecule non-steroidal selective estrogen receptor modulator |
Prostate cancer |
Monitors reviewing safety data recommended two pivotal Phase III trials continue as planned (9/5) |
Innovive |
INNO-105 |
Naturally occurring peptide that interacts with the OGFr receptor |
Advanced solid tumors |
Discontinued development after Phase I trial showed drug did not achieve desired plasma levels without producing adverse side effects (9/29) |
Maxygen Inc. |
Maxy-G34 |
Pegylated form of granulocyte-colony stimulating factor |
Chemotherapy- |
Began Phase I trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (9/5) |
MethylGene |
MGCD0103 |
Histone deacetylase inhibitor |
Advanced B-cell lymphomas |
Began Phase II single-agent trial to evaluate efficacy and other endpoints in up to 82 patients (9/15) |
Myriad |
Azixa |
Inducer of apoptosis |
Cancer that metastasized to the brain |
Phase I trial established the maximum tolerated dose; evidence of activity also was seen (9/25) |
NeoPharm |
IL13-PE38QQR |
Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38 |
Recurrent glioblastoma multiforme |
Follow-up data from Phase I/II trial continued to show evidence of prolonged overall survival (9/18) |
Northwest |
DCVax-LB |
Personalized vaccine made from a patient's dendritic cells |
Non-small-cell lung cancer |
Began Phase I trial to evaluate progression- ree and overall survival (9/7) |
OSI |
Tarceva (FDA-approved) |
Erlotinib; small-molecule |
Non-small-cell lung cancer |
Began a Phase III trial to evaluate the drug as an adjuvant therapy after surgery in 945 patients, to assess effect on disease-free survival (9/21) |
Oxford |
TroVax |
Immunotherapy vaccine that delivers an antigen (5T4) using a poxvirus vector |
Advanced breast cancer |
Is starting a Phase II open-label trial that will evaluate responses and survival in 160 patients (9/5) |
Rigel |
R763 |
Orally available, multi-Aurora kinase inhibitor |
Refractory solid tumors |
Serono began a Phase I trial in patients to evaluate safety and tolerability (9/19) |
SciClone |
Zadaxin |
Synthetic preparation of thymosin alpha-1 |
Malignant melanoma |
Interim trial data showed drug with dacarbazine doubled the overall tumor response vs. the control group (9/18) |
Sonus |
Tocosol Camptothecin |
Camptothecin-based agent formulated with vitamin E-based technology |
Advanced solid tumors |
Began Phase I trial to evaluate safety and antitumor effects in up to 61 patients (9/28) |
Synta |
STA-4783 |
Heat shock protein 70 |
Metastatic melanoma |
Phase IIb trial in 81 patients doubled progression-free survival vs. paclitaxel alone (9/11) |
VioQuest |
VQD-001 |
Sodium stibogluconate; inhibitor of protein tyrosine phosphatases |
Advanced solid tumors |
Began Phase I/II trial to evaluate safety, tolerability and pharmaco-kinetics with interferon alpha-2b in patients (9/26) |
VioQuest |
VQD-002 |
Triciribine-phosphate; targeted tricyclic nucleoside |
Leukemia |
Began Phase I/IIa trial of the product in that indication (9/12) |
CARDIOVASCULAR | ||||
Affymax Inc.* |
Hematide |
Synthetic, peptide-based erythropoiesis-stimulating agent |
Anemia |
Phase I trial showed increases in circulating reticulocytes and statistically significant increases in red blood cells (9/15) |
Alexion |
Soliris (eculizumab) |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Phase III TRIUMPH trial in 87 patients demonstrated significantly reduced symptoms vs. placebo (9/20) |
Arena |
MK-0354 |
Niacin receptor agonist; designed to regulate plasma lipid levels |
Atherosclerosis |
Merck ended development in that indication following Phase II trial in patients with dyslipidemia (9/25) |
Cardiome |
RSD1235 |
Oral formulation of drug designed to selectively block ion channels in the heart |
Atrial fibrillation |
61% of drug patients in Phase IIa trial completed the study in normal heart rhythm vs. 43% for the placebo; it was statistically significant for one of the two doses (9/13) |
Cerus Corp. |
Intercept Blood System |
Pathogen-inactivation system for red blood cells that uses the compound S-303 |
For use in blood transfusions |
Began Phase I trial to evaluate red blood cell recovery post-transfusion vs. untreated cells in 28 patients (9/12) |
Critical |
CTI-01 |
Ethyl pyruvate; small molecule believed to inhibit release of cytokines |
Complications of cardiac surgery |
Phase II data from 102 patients treated before trial was stopped due to a manufacturing issue showed no positive trends in efficacy vs. placebo (9/15) |
Cytokinetics |
CK-1827452 |
Cardiac myosin activator; intravenous formulation |
Heart failure |
Phase I trial in healthy volunteers established a maximum dose and showed improvements in heart function (9/13) |
EPIX |
PRX-00023 |
Long-acting 5-HT1A agonist |
Generalized anxiety disorder |
Phase III trial failed to demonstrate statistically significant improvement vs. placebo in the primary endpoint; it did show benefit in secondary endpoint related to depression (9/21) |
Genmab A/S |
HuMax-EGFr |
Zalutumumab; human antibody that targets the epidermal growth factor receptor |
Refractory head and neck cancer |
Began pivotal Phase III trial to evaluate efficacy with best supportive care against that care alone in up to 273 patients (9/14) |
Icagen Inc. |
ICA-17043 |
Small-molecule ion channel inhibitor |
Sickle cell disease |
Monitors recommended continuation of Phase III ASSERT trial for patients on concurrent hydroxyurea therapy; they earlier said treatment should stop in those not on hydroxyurea (9/12) |
Myogen Inc. |
Ambrisentan |
Ora lendothelin receptor antagonist |
Pulmonary hypertension |
Began open-label Phase III ARIES-3 trial to evaluate effect on exercise capacity in 200 patients from a range of PH subgroups (9/7) |
NitroMed Inc. |
BiDil (FDA-approved) |
Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine |
Heart failure in African-Americans |
Presented various positive data on efficacy, safety, tolerability, compliance and survival (9/11) |
Nuvelo Inc. |
rNAPc2 |
Recombinant nematode anticoagulant protein |
Acute coronary syndromes |
Phase II trial showed higher dose reduced ischemia by more than 50% (9/6) |
Pervasis |
Vascugel |
Cell therapy product that enables implantation of allogeneic endothelial cells |
Vascular injury |
Began Phase I trials to evaluate safety and feasibility in maintenance of vascular patency after creation of arteriovenous (AV) access graft and AV fistula (9/27) |
QuatRx |
QRX-431 |
Selective thyroid beta agonist |
High cholesterol/ obesity |
Began Phase I trial to evaluate the drug candidate (9/28) |
Vasogen Inc. |
Celacade |
Immune-modulation therapy; delivers oxidative stress to a patient's cells |
Advanced chronic heart failure |
New data from Phase III ACCLAIM trial showed statistical significance was reached in a large patient subset; overall, efficacy was not reached (9/5); new data showed a reduction in hospitalization days (9/13) |
ZymoGenetics |
rhThrombin |
Recombinant human thrombin |
Controlling blood loss during surgery |
Phase III trial vs. bovine thrombin met its primary endpoint of comparable hemostasis; also, antibody formation was lower in drug group (9/5) |
CENTRAL NERVOUS SYSTEM | ||||
Alexza |
AZ-004 |
Inhalation formulation of the antipsychotic drug loxapine |
Agitation in schizophrenic patients |
Began Phase IIa trial to evaluate safety and efficacy vs. placebo in 120 patients (9/22) |
Corcept |
Corlux |
Mifepristone; oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
Study 09, the second of three Phase III trials in treating the psychotic features of PMD, showed no meaningful improvement vs. placebo; secondary endpoints also were not met (9/29) |
CytRx Corp. |
Arimoclomol |
Small molecule designed to provide cellular protection by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
Phase IIa trial in 84 patients demonstrated safety and tolerability; no improvement was seen on disease progression (9/26) |
Evotec AG |
EVT 201 |
Partial positive allosteric modulator of the GABA-A receptor complex |
Insomnia |
Began Phase II trial to evaluate efficacy vs. placebo in 66 patients (9/21) |
Evotec AG |
EVT 301 |
Oral, selective and reversible inhibitor of monoamine oxidase B |
Alzheimer's disease |
Development was ended when abnormal liver data were seen in healthy volunteers participating in a safety study (9/13) |
Javelin |
Dyloject |
Diclofenac injection; nonsteroidal anti- inflammatory agent |
Pain |
Final Phase IIb data showed drug met primary endpoint of pain relief over six hours; all five doses showed statistical significance vs. placebo (9/14) |
Jazz |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Fibromyalgia syndrome |
Began a Phase III trial to evaluate safety and efficacy vs. placebo (9/7) |
MAP |
MAP0004 |
Formulation of dihydro- ergotamine mesylate delivered with MAP's inhaler |
Migraine |
Began Phase II trial to evaluate pain relief and other endpoints in 100 patients (9/5) |
Medivation |
Dimebon |
Neuroprotectant agent that's been on the market in Russia since 1983 |
Huntington's disease |
Is starting a Phase I/IIa trial to evaluate safety, tolerability and preliminary efficacy (9/28) |
Memory |
MEM 1003 |
Neuronal L-type calcium channel modulator |
Acute mania in bipolar disorder |
Began Phase IIa trial to evaluate safety and efficacy vs. placebo in 60 patients (9/5) |
NeurogesX |
Transacin (NGX-4010) |
High-concentration trans- capsaicin dermal patch |
HIV-associated neuropathy |
Open-label extension study showed reductions in pain over the entire 52-week study period (9/6) |
NovaDel |
-- |
Spray formulation of sumatriptan |
Migraine |
Pilot study demonstrated a statistically significant faster rate of absorption than Imitrex tablets (9/28) |
Pozen Inc. |
Trexima |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
Presented various positive data from several studies, including consistent efficacy over multiple migraine attacks (9/20) |
DIABETES | ||||
Amylin |
Symlin |
Pramlintide acetate; an |
Type II diabetes |
211-patient trial showed benefit of adding drug to basal insulin regimen in those failing to meet glucose targets (9/7) |
MannKind |
Technosphere Insulin |
Dry-powder formulation of insulin delivered by company's inhaler |
Type II diabetes |
Phase III trial showed comparable improvements in glycemic control when compared to injected insulin aspart (NovoLog) (9/18) |
Nastech |
-- |
Rapidly acting intranasal insulin formulation |
Diabetes |
Began a Phase I trial to evaluate safety, bioavailability and glucose response vs. approved agents (9/19) |
INFECTION | ||||
Acambis plc |
ChimeriVax- West Nile |
Vaccine against West Nile virus |
West Nile virus |
First part of Phase II trial showed a seroconversion rate of 97% in the 112 healthy adults participating (9/12) |
Advanced Life |
Cethromycin |
Second-generation ketolide antibiotic agent |
Infections |
Presented positive efficacy and safety data from Phase II and III trials in community- acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax infection (9/29) |
AlphaVax |
AVX101 |
Vaccine incorporating the HIV gag gene |
Prevention of HIV infection |
Preliminary Phase I data showed antibody responses to the HIV gag antigen in all those receiving the highest dose; vaccine was safe and well tolerated (9/6) |
BioCryst |
Peramivir |
Influenza neuraminidase inhibitor |
Influenza |
Phase I trials in 79 healthy volunteers demonstrated tolerability, and safety at high doses (9/29) |
Bioenvision |
Suvus |
Agent designed to prevent replication of DNA and RNA in pathogens |
Hepatitis C |
Phase II trial in chronic patients with HCV genotype 4a infection demonstrated reductions in viral load (9/8) |
Caprion |
Shigamabs |
Intravenous agent consisting of the monoclonal antibodies caStx1 and caStx2 |
Shigatoxin- producing E. coli infections |
Phase I trial in 40 healthy volunteers demonstrated safety and tolerability (9/19) |
Elusys |
Anthim (ETI-204) |
Monoclonal antibody that targets the protective antigen component of anthrax |
Anthrax infection |
Phase I trial demonstrated safety and tolerability, and a mean half-life of 16 days (9/28) |
Human Genome |
HGS004 |
Fully human monoclonal antibody that binds the chemokine receptor CCR5 |
HIV |
Phase I trial demonstrated tolerability, as well as antiviral activity, in patients (9/29) |
Iomai Corp. |
-- |
Needle-free, patch-based influenza vaccine |
Influenza |
Is starting a Phase I trial that will compare the product to the traditional vaccine in 300 patients (9/11) |
Medarex Inc. |
CDA-1 (MDX-066) and MDX-1388 |
Fully human monoclonal antibodies against C. difficile Toxin A and Toxin B, respectively |
C. difficile- associated diarrhea |
Began Phase II trial to evaluate the efficacy of the combination vs. placebo in up to 200 patients (9/6) |
Novelos |
NOV-205 |
Hepatoprotective agent with immunomodulating and anti-inflammatory properties |
Hepatitis C |
Began Phase Ib monotherapy trial in 30 chronic patients who have failed treatment with pegylated interferon plus ribavirin (9/28) |
Nventa Bio- |
HspE7 |
Therapeutic vaccine against the human papillomavirus |
HPV-related diseases |
81% of 27 patients with genital warts in Phase II trial had complete or partial responses (9/7) |
Protherics plc |
CytoFab |
Anti-TNF-alpha polyclonal antibody fragment |
Sepsis |
Full data from Phase IIb trial in 81 patients showed TNF-a neutralization and efficacy trends (9/5) |
SciClone |
SCV-07 |
Oral form of synthetic dipeptide; immuno- modulatory agent |
Viral infections |
Phase I trial demonstrated oral availability (9/15) |
Sequella Inc.* |
SQ109 |
Orally active diamine antibiotic |
Tuberculosis |
Began Phase I trial to evaluate safety and pharmacokinetics in 48 healthy volunteers (9/12) |
Vertex |
Lexiva (FDA-approved) |
Telzir; fosamprenavir calcium; protease inhibitor |
HIV |
48-week trial in treatment-naive patients demonstrated low rates of virologic failure and drug GlaxoSmithKline resistance (9/28) |
ViroPharma |
Maribavir |
Benzimidazole compound; oral inhibitor of cytomegalovirus |
Prevention of CMV infection in transplant patients |
Began Phase III trial to evaluate prophylactic benefit in 500 patients who have undergone allogeneic stem cell transplantation (9/28) |
MISCELLANEOUS | ||||
Aastrom |
Tissue Repair Cells |
Autologous bone marrow- derived adult stem and progenitor cells |
Long bone non-union fractures |
One-year data from 12 patients in Phase I/II trial showed 10 of them had bone bridging at the fracture site (9/15) |
Acuity |
Bevasiranib (Cand5) |
Small interfering RNA therapeutic designed to shut down VEGF |
Wet age-related macular degeneration |
Phase II CARE trial in 129 patients demonstrated safety, tolerability and biological effects (9/11) |
Adolor Corp. |
Entereg/Entrareg |
Alvimopan capsules; muopioid antagonist |
Opioid-induced bowel dysfunction |
One Phase III trial met its primary endpoints, while another Phase III trial, as well as a Phase II trial, failed to demonstrate statistical significance (9/5) |
Amgen Inc. |
Denosumab (AMG 162) |
Fully human antibody targeting RANK Ligand, a mediator of osteoclasts |
Bone loss |
Post-hoc analysis of Phase II trial showed improvements in bone mineral density and in parameters of hip structural analysis (9/19) |
Arena |
Lorcaserin hydrochloride |
Oral, selective stimulator of the 5-HT2C serotonin receptor |
Obesity |
Began first of three planned Phase III trials; the BLOOM study will evaluate safety and efficacy in 300 patients (9/12) |
BioMimetic |
GEM 21S |
Synthetic bone matrix combined with PDGF, a tissue growth factor |
Periodontal disease and gingival recession |
Follow-up data from pivotal trial showed a statistically significant increase in bone fill vs. treatment with the Beta-TCP matrix alone (9/18) |
Dynogen |
DDP733 |
Oral, serotonin type 3 receptor partial agonist |
Gastroesophageal reflux disease |
Began Phase Ib trial to evaluate safety; efficacy also will be studied (9/13) |
Indevus |
Pagoclone |
Non-benzodiazepine, selective GABA-A receptor agonist |
Premature ejaculation |
Phase II trial was discontinued due to insufficient efficacy (9/26) |
Jerini AG |
Icatibant |
Bradykinin B2 receptor antagonist |
Hereditary angioedema |
Pivotal Phase III FAST-2 trial showed a significant reduction in the time to onset of symptom relief; |
Kalypsys |
KD3010 |
Small-molecule peroxi- some proliferator-activator receptor delta agonist |
Metabolic disorders/ obesity |
Began Phase Ia trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (9/26) |
MacuSight |
-- |
Company's formulation of sirolimus (rapamycin) |
Diabetic macular edema |
Began Phase I trial to evaluate safety and tolerability of two types of ocular injections in 30 patients (9/26) |
Neurocrine |
NBI-56418 |
Small-molecule gonado- tropin- releasing hormone receptor antagonist |
Endometriosis |
Follow-on data from Phase II trial showed favorable safety and efficacy; Phase IIb trial is planned (9/12) |
Nucryst |
NPI 32101 |
Topical cream formulation of nanocrystalline silver |
Atopic dermatitis |
Phase II trial in 409 patients failed to demonstrate significant difference in disease clearance vs. placebo (9/20) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Phase II trial in 175 patients demonstrated statistical significance vs. placebo in symptom scores (9/19) |
Orexigen |
Contrave |
Agent combining bupropion with one of several doses of naltrexone |
Obesity |
Data from 24-week Phase III trial showed significant advantages in weight loss vs. placebo, and it outperformed either naltrexone or bupropion given alone (9/26) |
Ortec |
OrCel |
Collagen sponge seeded with allogeneic epidermal and dermal cells |
Venous leg ulcers |
Confirmatory trial demonstrated statistically significant wound closure vs. placebo; a PMA filing was planned (9/12) |
Progenics |
Methyl- |
Intravenous mu opioid receptor antagonist |
Postoperative ileus |
Began first of two pivotal Phase III trials, to evaluate safety and efficacy in 500 patients who have undergone segmental colectomy surgery (9/20) |
Tranzyme |
TZP-101 |
Selective ghrelin receptor agonist |
Gastroparesis |
Began Phase I trial to evaluate the agent in diabetic patients suffering from gastroparesis (9/21) |
Vivus Inc. |
Alista |
Topical formulation of alprostadil |
Female sexual arousal disorder |
Phase IIb trial in women who have undergone a hysterectomy did not show a statistically significant increase vs. placebo in satisfactory sexual events (9/29) |
Zelos |
Ostabolin-C |
Inhaled powder formulation of Zelos' parathyroid hormone |
Osteoporosis |
Began Phase I trial to evaluate safety, tolerability and pharma-cokinetics in up to 56 healthy postmenopausal women (9/21) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; | ||||
NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange. | ||||
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