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Allergan receives positive opinion from Irish Medicines Board for BOTOX

Allergan is pleased to announce that BOTOX has received a positive opinion from the Irish Medicines Board for the management of urinary incontinence in adults with neurogenic detrusor overactivity (NDO) resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis.

8 Aug 2011

VIVUS announces additional data from phase 3 QNEXA studies on obesity

VIVUS, Inc. today announced that additional data from the phase 3 QNEXA studies will be presented today during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV.

6 Aug 2011

Idera second quarter net loss increases to $6.3 million

Idera Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2011. Idera is a biotechnology company engaged in the discovery and development of DNA- and RNA-based drug candidates targeted to Toll-Like receptors (TLRs).

5 Aug 2011

Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration in response to a Complete Response Letter (CRL) received in October 2010.

5 Aug 2011

ESC to produce focused update on AF Guidelines following early termination of PALLAS Trial

The Guidelines Department of the European Society of Cardiology has issued the following statement today: "The European Society of Cardiology (ESC) is aware of the early termination of the PALLAS trial because of adverse outcomes associated with dronedarone.

5 Aug 2011

Takeda, Amylin discontinue pramlintide/metreleptin development program for obesity

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today announced that they are discontinuing development of pramlintide/metreleptin, an investigational combination therapy for the treatment of obesity that comprises pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin.

5 Aug 2011

YM BioSciences reports preclinical results of CYT387 in multiple myeloma

YM BioSciences Inc., today reported preclinical results for its JAK1/JAK2 inhibitor CYT387 in multiple myeloma (MM), published in the advance online edition of Leukemia on July 26, 2011.

5 Aug 2011

FDA grants Orphan Drug Designation to Kamada's AAT product for type 1 diabetes

Kamada LTD., a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, was granted an Orphan Drug Designation for its Alpha-1 Antitrypsin (AAT) product to treat type 1 diabetes.

5 Aug 2011

Positive results from Antares Pharma VIBEX MTX clinical study on RA

Antares Pharma, Inc. today announced the positive results of a clinical study evaluating VIBEX MTX, a proprietary auto injector product designed to give a rapid subcutaneous injection of methotrexate (MTX) for the treatment of rheumatoid arthritis.

5 Aug 2011

OncoGenex second quarter revenue increases to $1.9 million

OncoGenex Pharmaceuticals, Inc. today provided an update on current events and activities and announced its second quarter financial results.

5 Aug 2011

Dyax initiates ecallantide Phase 2 trial for ACE inhibitor-induced angioedema

Dyax Corp. announced today treatment of the first patient in a Phase 2 trial evaluating the efficacy and safety of ecallantide, a potent, selective, reversible inhibitor of plasma kallikrein, for acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema.

4 Aug 2011

Palatin confirms initiation of AZD2820 Phase 1 trial in obesity

Palatin Technologies, Inc. confirmed today the commencement of a Phase 1 clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist, under development as a single-agent therapy for the treatment of obesity.

4 Aug 2011

Positive results from hGH-CTP Phase II trial in growth hormone deficient adults

PROLOR Biotech, Inc. today reported positive results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults.

4 Aug 2011

NIH-funded study to assess biomarkers in the blood of TBI patients

Biomarkers in the bloodstream could provide physicians with a quick and accurate method of assessing the severity of traumatic brain injury (TBI) and helping deliver and monitor the results of therapies, such as progesterone treatment.

4 Aug 2011

Pharming, Santarus reach SPA agreement with FDA for RHUCIN Phase III trial

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application.

4 Aug 2011

Acceleron, Celgene enter development collaboration for ACE-536 protein therapeutic to treat anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, and Celgene Corporation today announced that the companies have entered into a joint development and commercialization agreement for ACE-536 for the treatment of anemia.

3 Aug 2011

Positive results from combination drug trial for late-stage ovarian cancer

An experimental two-drug combination for treating late-stage ovarian cancer continues to produce strong results, leading its Indiana University researchers to actively pursue the next step, conducting a larger clinical trial to test the therapy and to see how it compares with existing treatments for ovarian cancer.

3 Aug 2011

Risperidone does not appear to reduce military-related PTSD symptoms

Patients with military-related, chronic posttraumatic stress disorder (PTSD) and symptoms that were not improved with use of an antidepressant medication did not experience a reduction in PTSD symptoms with use of the antipsychotic medication risperidone, according to a study in the August 3 issue of JAMA, a theme issue on violence and human rights.

3 Aug 2011

Memantine drug could boost cognitive function in people with Down syndrome

A University of Colorado School of Medicine scientist is completing a major clinical trial on a drug that could boost cognitive function in those with Down syndrome, significantly improving their quality of life and representing a potential milestone in research on this genetic condition.

3 Aug 2011

GSK, NPS enter agreement to evaluate ronacaleret in new indications

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported that it has entered into a new agreement with GlaxoSmithKline (GSK), that terminates and replaces a prior collaborative research and license agreement between NPS and GSK from 1993, which focused on the discovery and development of small molecule antagonists of the calcium receptor that increase secretion of parathyroid hormone.

3 Aug 2011