Clinical Trial News and Research

RSS

FDA assigns CTIs' pixantrone NDA new PDUFA action date

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration's Division of Oncology Products 1 has notified CTI that CTI's October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.

6 Dec 2011

EnVivo presents positive EVP-6124 Phase 2b trial data on schizophrenia at 50th ACNP meeting

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it is presenting the comprehensive analysis of a recently completed Phase 2b clinical trial of EVP-6124, a novel, orally bioavailable nicotinic alpha-7 agonist, in schizophrenia at the American College of Neuropsychopharmacology 50th Anniversary Annual Meeting.

5 Dec 2011

Fatal snakebites emerging global threat

Fatal snakebites are a bigger-than-acknowledged global health problem that has been vastly under-reported, according to research presented today at the American Society of Tropical Medicine and Hygiene’s (ASTMH) annual meeting.

5 Dec 2011

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

XenoPort, Inc. announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet (immediate-release levodopa/carbidopa) or XP21279 co-formulated with carbidopa (279/CD) in advanced Parkinson's disease patients with motor fluctuations.

5 Dec 2011

Zalicus commences Z160 Phase 1 clinical trial for pain

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker.

5 Dec 2011

Moffitt investigators to participate with 16 oral and 50 posters presentations at 53rd ASH meeting

When the American Society of Hematology convenes its 53rd Annual Meeting and Exposition on Dec. 10-13 in San Diego, Calif., researchers from Moffitt Cancer Center will break a new record for Moffitt participants with one plenary presentation, 16 oral presentations and more than 50 poster presentations on new research results in a variety of meeting programs that focus on blood cancer basic science and clinical applications, including bone marrow transplantation and clinical trials results.

5 Dec 2011

Bromide shows promise against SCN1A-associated Dravet syndrome with intractable seizures

In the mid-nineteenth century Charles Locock, physician to Queen Victoria, introduced bromide as the first effective treatment for epilepsy. The drug was little used in treating the disorder until 1868, however, when its efficacy against seizures was first demonstrated in a clinical trial. Bromide was the sole anticonvulsant available until 1912 and the introduction of phenobarbital.

5 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Progesterone can benefit women with catamenial seizures: Study

Seizures in women of childbearing age commonly show patterns of exacerbation that involve hormones as a factor. Investigators today reported the favorable outcome of a multicenter randomized, double-blinded, placebo-controlled phase III clinical trial of progesterone therapy in reducing these perimenstrually exacerbated (catamenial) seizures.

3 Dec 2011

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint

Oncolytics Biotech Inc. today announced that interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.

3 Dec 2011

University of Illinois Hospital prescribes Tumor Treating Fields therapy for recurrent GBM

The University of Illinois Hospital is the first center in North America to prescribe a new FDA-approved treatment for patients with the most common and aggressive type of brain tumor, glioblastoma multiforme, or GBM.

3 Dec 2011

Blocking telomerase increases cancer cells' sensitivity to radiation treatment

Shortening end caps on chromosomes in human cervical cancer cells disrupts DNA repair signaling, increases the cells' sensitivity to radiation treatment and kills them more quickly, according to a study in Cancer Prevention Research.

2 Dec 2011

Longer looks: Life of a Medicare demo project; Broken hearts; AIDS funding

Today's Medicare demonstration project might determine how physicians interact with the program tomorrow, so naturally such projects generate a lot of buzz in the health care community. Lately, some of that buzz has been about how demos might provide part of the solution for Medicare's payment problems.

2 Dec 2011

John Theurer Cancer Center to present results of 31 studies at ASH 2011 meeting

The John Theurer Cancer Center at Hackensack University Medical Center, one of the nation's top 50 best hospitals for cancer, will present research updates and clinical trial results of 31 cutting-edge studies at the 2011 American Society of Hematology (ASH) Annual Meeting in San Diego from December 10-13.

2 Dec 2011

Scottsdale resident donates $1 million to TGen pancreatic cancer initiative

A son's passion to find a cure for the cancer that claimed the life of his mother has led to a new series of clinical trials under a Translational Genomics Research Institute (TGen) initiative to find a cure for pancreatic cancer.

2 Dec 2011

First results from whole-genome sequencing clinical trial on triple negative breast cancer

Triple negative breast tumors, which make up nearly 20 percent of breast cancers, do not respond to treatment with targeted therapies such as Herceptin-(trastuzumab).

2 Dec 2011

FDA issues draft guidance on artificial pancreas system

The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

2 Dec 2011

Two studies uncover limitations in screening for hepatocellular carcinoma

Two studies available in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases, have uncovered limitations in screening for primary liver cancer, also known as hepatocellular carcinoma.

2 Dec 2011

Cheaper test as effective as a more sophisticated test in guiding anti-retroviral drug treatment

A cheaper laboratory test that helps guide anti-retroviral drug treatment for people with HIV/AIDS may be just as effective as a more sophisticated test, a group of international researchers has found - a discovery that could be particularly important in rural Africa.

2 Dec 2011

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

Idera Pharmaceuticals, Inc. today announced the receipt of verbal notification from the Food and Drug Administration that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the company in October 2011.

2 Dec 2011

Clinical Trial News and Research

FDA assigns CTIs' pixantrone NDA new PDUFA action date

EnVivo presents positive EVP-6124 Phase 2b trial data on schizophrenia at 50th ACNP meeting

Fatal snakebites emerging global threat

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

Zalicus commences Z160 Phase 1 clinical trial for pain

Moffitt investigators to participate with 16 oral and 50 posters presentations at 53rd ASH meeting

Bromide shows promise against SCN1A-associated Dravet syndrome with intractable seizures

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Progesterone can benefit women with catamenial seizures: Study

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint

University of Illinois Hospital prescribes Tumor Treating Fields therapy for recurrent GBM

Blocking telomerase increases cancer cells' sensitivity to radiation treatment

Longer looks: Life of a Medicare demo project; Broken hearts; AIDS funding

John Theurer Cancer Center to present results of 31 studies at ASH 2011 meeting

Scottsdale resident donates $1 million to TGen pancreatic cancer initiative

First results from whole-genome sequencing clinical trial on triple negative breast cancer

FDA issues draft guidance on artificial pancreas system

Two studies uncover limitations in screening for hepatocellular carcinoma

Cheaper test as effective as a more sophisticated test in guiding anti-retroviral drug treatment

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

eBook: Using iPSCs models for human disease research and drug discovery eBook

Latest eBooks

Industry Focus eBook - Microbiome (1st edition)

Industry Focus eBook - Cell biology (5th edition)

Advancing degrader and proximity-based drug development

Driving innovation in Korean drug development

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Applications Engineer