Efficacy News and Research

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Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Hyperion Therapeutics today announced that the first patient has been enrolled in a clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate) in children ages 6-17 with urea cycle disorders (UCD). The study will evaluate the safety, tolerability, and ammonia control of glycerol phenylbutyrate compared to BUPHENYL® (sodium phenylbutyrate).

15 Sep 2009

Implantable defibrillator therapy not beneficial for women with heart failure

Implantable cardioverter-defibrillators do not appear to be associated with a reduced risk of death in women with advanced heart failure, according to a meta-analysis of previously published research in the September 14 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

15 Sep 2009

Extension study data on Fampridine-SR drug

Data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment time of 36 months in study MS-F203EXT.

15 Sep 2009

NYSDOH blocks U.S.-Egypt study of ozone-based medical therapies for diabetic skin ulcers

A study exploring the healing of diabetic skin ulcers using topical oxygen/ozone gas mixtures could not proceed to completion and was now abandoned, according to Ozonics International, LLC, a veteran-owned biotechnology company engaged in the research and development of ozone-based medical therapies.

15 Sep 2009

GlaxoSmithKline's Votrient will take significant market share away from Pfizer's Sutent by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that, following its launch and uptake, GlaxoSmithKline's angiogenesis inhibitor Votrient (formerly Armala) will garner sales of $640 million by 2018 and will take significant market share away from Pfizer's Sutent. In 2008, Sutent had accounted for 61 percent of sales in the angiogenesis inhibitor drug class.

15 Sep 2009

A.P. Pharma and Merial sign license and development agreement for a long-acting pain management product

A.P. Pharma (Nasdaq:APPA), a specialty pharmaceutical company, today announced that it has entered into a license and development agreement with Merial, a world leading animal health company, for a long-acting pain management product.

15 Sep 2009

FluCide more effective than Tamiflu

NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), announced today that Anil Diwan, PhD, President of the Company presented a talk at NanoBusiness 2009 - the 8th annual NanoBusiness Conference in Chicago, IL, on Wednesday, September 9th.

15 Sep 2009

NSF International certification for COLD-FX(R)

Afexa Life Sciences Inc. ("Afexa") (TSX:FXA) today announced that COLD-FX(R) has received the highest sports certification in North America from the leading product safety and banned substances testing body for elite athletes.

15 Sep 2009

MSD's ISENTRESS approved by the EU Commission for treating HIV-1 infection in adult patients

Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients.

15 Sep 2009

Triamcinolone may be a treatment option for some patients with retinal vein occlusion

Injecting the eye with the corticosteroid triamcinolone appears effective in improving the vision of some patients with retinal vein occlusion, an important cause of vision loss that results from blockages in the blood vessels in the retina, according to two reports in the September issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

15 Sep 2009

Phase III results of Lauriad presented at the 49th Annual ICAAC

BioAlliance Pharma has attended the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco to present results on miconazole Lauriad and anti-integrase inhibitor.

15 Sep 2009

Dominion develops and validates clinical quantitative assays for tapentadol

Dominion Diagnostics (Dominion) has recently developed and validated one of the first clinical quantitative assays for the drug tapentadol (Nucynta(TM)) performed by liquid chromatography/tandem mass spectrometry (LC/MS/MS). Tapentadol, recently approved for use by the FDA, is a centrally-active analgesic that has demonstrated efficacy in pain relief with improved gastrointestinal tolerability compared to other opioids for pain management.

15 Sep 2009

New 'adjuvant' developed by scientists could allow the creation of important new vaccines

Scientists at Oregon State University have developed a new "adjuvant" that could allow the creation of important new vaccines, possibly become a universal vaccine carrier and help medical experts tackle many diseases more effectively.

15 Sep 2009

Cell Therapeutics submits Pediatric Investigation Plan to EMEA for pixantrone

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) as part of the required filing process for approval of pixantrone for treating relapsed or refractory, aggressive non-Hodgkin's Lymphoma (NHL) in Europe. The PIP outlines how the company proposes to study the drug in children in order to benefit child health.

15 Sep 2009

Phase 2b trial of Mpex's Aeroquin with PARI Pharma's eFlow Nebulizer System successful

Mpex Pharmaceuticals, Inc. reported positive top line results from a Phase 2b clinical trial with Aeroquin, a novel aerosol formulation of levofloxacin delivered by an optimized Investigational eFlow Nebulizer System from PARI Pharma. In the Mpex cystic fibrosis trial, nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa in sputum after 28 days of dosing versus placebo.

15 Sep 2009

FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

Diagnostic HYBRIDS, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.

15 Sep 2009

BioAlliance announces Phase III results of miconazole Lauriad MBT for treatment of oropharyngeal candidiasis

Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat.

14 Sep 2009

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Achaogen, a clinical stage biopharmaceutical company addressing the issue of multi-drug resistant bacterial infections through the discovery and development of innovative, broad-spectrum antibiotics, today announced the results of a Phase 1 trial and preclinical data on its lead drug candidate ACHN-490 at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting in San Francisco, CA.

14 Sep 2009

Aeolus commences second study of AEOL 10150 against Acute Radiation Syndrome

Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today the initiation of a second study, in mice, to determine the optimal length of treatment with AEOL 10150 when used as a countermeasure to Acute Radiation Syndrome (ARS) in the lungs. This study, led by Zeljko Vujaskovic, M.D. Ph.D. of Duke University, is designed to build on the recently completed study that demonstrated the efficacy of AEOL 10150 as a treatment for damage to the lungs due to exposure to radiation, and determine the most effective duration of delivery for treatment after exposure.

14 Sep 2009

Phase 2b clinical trial results of Dextofisopam to treat irritable bowel syndrome announced

Pharmos Corporation (Pink Sheets: PARS) announced today the results of its Phase 2b Dextofisopam clinical trial to evaluate safety and efficacy of the compound in irritable bowel syndrome.

14 Sep 2009

Efficacy News and Research

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Implantable defibrillator therapy not beneficial for women with heart failure

Extension study data on Fampridine-SR drug

NYSDOH blocks U.S.-Egypt study of ozone-based medical therapies for diabetic skin ulcers

GlaxoSmithKline's Votrient will take significant market share away from Pfizer's Sutent by 2018

A.P. Pharma and Merial sign license and development agreement for a long-acting pain management product

FluCide more effective than Tamiflu

NSF International certification for COLD-FX(R)

MSD's ISENTRESS approved by the EU Commission for treating HIV-1 infection in adult patients

Triamcinolone may be a treatment option for some patients with retinal vein occlusion

Phase III results of Lauriad presented at the 49th Annual ICAAC

Dominion develops and validates clinical quantitative assays for tapentadol

New 'adjuvant' developed by scientists could allow the creation of important new vaccines

Cell Therapeutics submits Pediatric Investigation Plan to EMEA for pixantrone

Phase 2b trial of Mpex's Aeroquin with PARI Pharma's eFlow Nebulizer System successful

FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

BioAlliance announces Phase III results of miconazole Lauriad MBT for treatment of oropharyngeal candidiasis

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Aeolus commences second study of AEOL 10150 against Acute Radiation Syndrome

Phase 2b clinical trial results of Dextofisopam to treat irritable bowel syndrome announced

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