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FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.

26 Aug 2010

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent.

26 Aug 2010

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that results of a Phase 1 clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and pre-clinical data on Cerulean's development candidate, CRLX288, were presented at the American Chemical Society National Meeting & Exposition, ongoing in Boston, Massachusetts.

26 Aug 2010

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

26 Aug 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Nabi Biopharmaceuticals announced the receipt of a patent for treating and preventing nicotine addiction with NicVAX® and related nicotine conjugate vaccines. The United States Patent and Trademark office issued U.S. Patent No. 7,776,620 entitled "Hapten-carrier conjugates for treating and preventing nicotine addiction" for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.

26 Aug 2010

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

Afferent Pharmaceuticals, a clinical-stage biopharmaceutical company developing first-in-class, small molecule compounds that target P2X3 receptors, today announced preclinical in vivo results demonstrating that an investigational P2X3 receptor antagonist reduced experimentally induced bladder hyperactivity.

26 Aug 2010

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

CHX Technologies Inc., a private Canadian pharmaceutical company that is developing new treatments for the prevention of dental diseases, today announced successful results in its final controlled pivotal trial of Prevora, its proprietary antibacterial tooth coating for the prevention of cavities. The trial surpassed objectives set by the Food and Drug Administration (FDA) protocol, clearing the way for CHX to start the process of seeking FDA approval for use in the United States.

25 Aug 2010

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc., today announced that the National Institute of Health/National Institute of Allergy and Infectious Disease, has awarded its research partner, the University of Rochester Medical Center (URMC), a $15 million five-year, continuation grant for studies that will utilize ImmuneRegen's Homspera.

25 Aug 2010

Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

Bristol-Myers Squibb Company and Pfizer report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the "Hot Line" session on August 31, 2010, in Stockholm, Sweden.

25 Aug 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

25 Aug 2010

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine, Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin Phase 2 data at this year's Joint International NGM Meeting on Saturday, August 28, 2010.

25 Aug 2010

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4 mg and 8 mg doses compared to placebo.

25 Aug 2010

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies.

24 Aug 2010

FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP.

24 Aug 2010

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

Pharmasset, Inc. announced today that dosing has begun in a Phase 2b study of PSI-7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977 200mg QD and 400mg QD in combination with pegylated interferon alfa 2a and ribavirin, the current standard of care (SOC) in patients with HCV genotype 1 who have not been treated previously.

24 Aug 2010

USPTO grants Taligen patent for TT30 lead product candidate

Taligen Therapeutics, a biotechnology company developing therapies that regulate the complement system to treat inflammatory and immune diseases, announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,759,304, entitled "Targeting Complement Factor H For Treatment of Diseases", covering the composition of matter for its lead product candidate, TT30, a novel fusion protein that selectively binds to complement activated cells to locally regulate the complement system.

24 Aug 2010

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

Pfizer Inc. announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).

24 Aug 2010

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

24 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

Drug Trial News

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

USPTO grants Taligen patent for TT30 lead product candidate

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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