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NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

Sanaria Inc. has received additional support from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health in the form of a Phase II Small Business Innovation Research (SBIR) Grant. The award for two years is $1.99 million. Subject to satisfactory progress by Sanaria, continued funding for a third year will bring the total to nearly $3 million.

16 Sep 2009

FDA grants orphan drug status to Advanced Life Sciences' Restanza

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Restanza(TM) (cethromycin), its novel, once daily oral antibiotic, for the prophylactic treatment of plague and tularemia. Both tularemia and plague are classified by the Centers for Disease Control as Category A Bioterrorism Agents, which is the highest priority classification.

16 Sep 2009

BCLI collaborates with HBI to complete pre-clinical safety experiments

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies and therapeutics, announced today that it has entered into a strategic agreement with Harlan Biotech Israel Ltd (HBI), a leading Good Laboratory Practice contractor, in order to complete pre-clinical safety experiments for the company’s innovative therapy for ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease).

15 Sep 2009

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

Efficacy News and Research

NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

FDA grants orphan drug status to Advanced Life Sciences' Restanza

BCLI collaborates with HBI to complete pre-clinical safety experiments

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

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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