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Study shows beneficial anti-fibrotic effects of Pentraxin-2 in idiopathic pulmonary fibrosis

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today the publication of collaborative research in the International Journal of Biochemistry and Cell Biology entitled, "TGF-beta driven lung fibrosis is macrophage dependent and blocked by Serum amyloid P."

14 Feb 2011

Phase III RISE study of Lucentis for DME meets primary endpoint

Genentech, Inc., a member of the Roche Group, announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.

14 Feb 2011

Last patient in EU Diamyd Phase III clinical study completes 15-month visit for type 1 diabetes

The last patient in the EU Diamyd Phase III clinical study has completed the 15-month visit, meaning that all patients in this study have completed the main 15 month study period in this trial. This important achievement in the Diamyd® Phase III program will now be followed by an intense period where the data will be compiled from the more than 60 clinics throughout Europe and from the central laboratory.

14 Feb 2011

JTH publishes positive TB-402 Phase II trial results for VTE treatment after orthopaedic surgery

ThromboGenics NV and co-development partner BioInvent International announce today that the positive TB-402 Phase II trial results, evaluating the product's efficacy and safety for the prevention of venous thromboembolism afterorthopaedic surgery, have been published in the Journal of Thrombosis and Haemostasis.

14 Feb 2011

Positive safety data from BioSante's ongoing LibiGel Phase III study in women with HSDD

BioSante Pharmaceuticals, today announced positive safety data in its ongoing LibiGel Phase III clinical development program.

13 Feb 2011

FDA grants Inhibitex Fast Track Designation for INX-189 in treatment of chronic hepatitis C viral infection

Inhibitex, Inc. today reported that the U.S. Food and Drug Administration ("FDA") has designated the investigation of INX-08189, a potent guanosine nucleotide polymerase inhibitor for the treatment of chronic hepatitis C viral infection, as a Fast Track development program.

11 Feb 2011

Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 1b clinical study of PRM-151 to explore the safety, tolerability, pharmacokinetics, and phamacodynamics of PRM-151 in the treatment of patients with idiopathic pulmonary fibrosis.

11 Feb 2011

Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.

10 Feb 2011

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer. Tesetaxel, the leading oral taxane in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.

10 Feb 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Zogenix, Inc. announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

10 Feb 2011

EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

QLT Inc. today announced that QLT091001, an oral synthetic retinoid, has received positive opinions for two distinct Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for the treatment of the inherited retinal degenerative diseases, Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP).

10 Feb 2011

Vical 2010 net loss increases to $30.4 million

Vical Incorporated today reported financial results for the year ended December 31, 2010. Vical had cash and investments of approximately $61 million at year-end 2010. The company received approximately $37 million of net proceeds from the sale of equity securities during 2010.

10 Feb 2011

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Diamyd Medical´s US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the ClinicalTrials.gov website.

10 Feb 2011

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

In a study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting -, in San Francisco, researchers will present findings that show that the use of the hormone 17-Hydroxyprogesterone does not reduce the rate of preterm delivery or neonatal complications in twins.

10 Feb 2011

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE™ (beclomethasone dipropionate [BDP]) HFA, its nasal aerosol corticosteroid in development for the treatment of perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR).

10 Feb 2011

Everolimus phase III study shows improved progression-free survival in patients with pNET

In an international Phase III randomized study, everolimus, an inhibitor of the mammalian target of rapamycin, has shown to dramatically improve progression-free survival for patients with advanced pancreatic neuroendocrine tumors, according to researchers from The University of Texas MD Anderson Cancer Center.

9 Feb 2011

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes.

9 Feb 2011

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has initiated a Phase 2 clinical trial, following conclusion of a review by the United States Food and Drug Administration (FDA) of a protocol submitted by PolyMedix, to assess the safety and efficacy of its heptagonist, PMX-60056, in reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures.

9 Feb 2011

Drug Trial News

Study shows beneficial anti-fibrotic effects of Pentraxin-2 in idiopathic pulmonary fibrosis

Phase III RISE study of Lucentis for DME meets primary endpoint

Last patient in EU Diamyd Phase III clinical study completes 15-month visit for type 1 diabetes

JTH publishes positive TB-402 Phase II trial results for VTE treatment after orthopaedic surgery

Positive safety data from BioSante's ongoing LibiGel Phase III study in women with HSDD

FDA grants Inhibitex Fast Track Designation for INX-189 in treatment of chronic hepatitis C viral infection

Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection

Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

Vical 2010 net loss increases to $30.4 million

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Everolimus phase III study shows improved progression-free survival in patients with pNET

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

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