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AMT's MAA for LPLD gene therapy product Glybera on schedule

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today announced that the Marketing Authorisation Application (MAA) for Glybera(R) remains on schedule following meetings with the European Medicine Agency (EMA) concerning the Day 120 List of Questions. The company is confident that Glybera(R), a gene therapy product for lipoprotein lipase deficiency (LPLD), remains on track for a regulatory decision by mid-2011.

18 Aug 2010

Lilly to halt development of potential Alzheimer's disease drug semagacestat

Eli Lilly and Company will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.

18 Aug 2010

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

Researchers from this international study found that patients with chronic hepatitis B virus (HBV) infection who received at least 3 years of cumulative entecavir (antiviral) therapy achieved substantial histologic improvement and regression of fibrosis or cirrhosis. Full details of the study appear in the September issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

18 Aug 2010

BioMarin commences Phase 3b study of Kuvan's neuropsychiatric effects in phenylketonuria patients

BioMarin Pharmaceutical Inc. announced today that the first subject has initiated treatment in a Phase 3b study (PKU-016) to evaluate the effects of Kuvan (sapropterin dihydrochloride) on neuropsychiatric symptoms in subjects with phenylketonuria (PKU). BioMarin expects to report results in the first half of 2012.

18 Aug 2010

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

Palatin Technologies, Inc. today announced positive results of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without sustained clinically significant blood pressure effects and support the continued development of bremelanotide.

17 Aug 2010

Xenon Pharmaceuticals commences phase 2 clinical trial of XEN402 therapy for PHN

Xenon Pharmaceuticals Inc. announced today that it has initiated a phase 2 clinical trial evaluating its novel topical XEN402 therapy for the treatment of PHN.

17 Aug 2010

Hospitals save $284 million through Premier's Quality Connect quality improvement program

Hospitals participating in a Premier healthcare alliance quality improvement program have saved more than $284 million over the past year through improvements in clinical performance and enhancements in professional practice evaluation.

17 Aug 2010

Intercell reports significant increase in second quarter revenue

Today, Intercell AG announced its financial results for Q2 and H1 2010.IXIARO/JESPECT sales increased significantly from EUR 2.4m in Q2 2009 to EUR 5.2m in Q2 2010 Continued focus on growing marketing and sales of product in traveler and military markets

17 Aug 2010

Key scientific work in Cardio3 BioSciences' C-Cure stem cell heart failure treatment published in JACC

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular disease, today announces that the key scientific work underlying its lead pharmaceutical product C-Cure(R), a revolutionary stem cell treatment for heart failure, has been published in the Journal of the American College of Cardiology (JACC). The findings were described as "landmark work" in the accompanying editorial in today's publication.

17 Aug 2010

Experimental drug benefits women with advanced ovarian or breast tumours caused by BRCA gene faults

An experimental drug called olaparib has been shown to shrink tumours in women whose advanced cancers were caused by faults in their BRCA genes.

17 Aug 2010

Oral contraceptives equally effective for obese women

The first study to compare the effectiveness of the birth control pill in women with marked weight differences has found that the pill works equally well in women with obesity and thinner women. This new finding by physician-scientists at NewYork-Presbyterian Hospital/Columbia University Medical Center refutes a long-held conviction among many doctors that the pill may not reliably prevent pregnancy in women who are overweight or obese.

17 Aug 2010

Antidepressant alleviates depression in peri- and postmenopausal women: Study

An antidepressant can alleviate symptoms of major depression in women experiencing or about to experience menopause, according to a study released today led by a Virginia Commonwealth University researcher.

17 Aug 2010

Emisphere second-quarter net loss increases to $13.7 million

Emisphere Technologies, Inc. today announced financial and operational results for the three and six months ended June 30, 2010.

16 Aug 2010

Liverpool scientists create new drug for malaria

As part of the -1.5 million project, researchers are now testing the drug to determine how the treatment could progress to clinical trials. The drug is made from simple organic molecules and will be cheaper to mass produce compared to existing therapies.

16 Aug 2010

Enrollment open in Phase I clinical study of Morphotek's MORAb-028 for advanced melanoma

Morphotek, Inc., a subsidiary of Eisai Inc., announced today that the John Wayne Cancer Institute in Santa Monica, California has opened enrollment in a Phase I clinical study with MORAb-028 in patients with advanced melanoma.

16 Aug 2010

Titan Pharmaceuticals second-quarter net loss increases to $1.84 million

Titan Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2010.

16 Aug 2010

NanoViricides' anti-Herpes drug candidates demonstrate significant efficacy in cell culture studies

NanoViricides, Inc., reports that its anti-Herpes drug candidates demonstrated significant efficacy in the recently completed cell culture studies. The studies were performed in the laboratory of Dr. Ken Rosenthal at Northeastern Ohio Universities Colleges of Medicine and Pharmacy.

16 Aug 2010

NIDA grants Selecta Biosciences $3M to develop nicotine vaccine for smoking cessation and relapse prevention

Selecta Biosciences, Inc., a biopharmaceutical company developing synthetic nanoparticle vaccines and immunotherapies, today announced that it has been awarded a grant for $3 million from the National Institute on Drug Abuse (NIDA), an institute within the U.S. National Institutes of Health. The grant is aimed at advancing the development of an enhanced therapeutic nicotine vaccine for the treatment of smoking cessation and relapse prevention.

16 Aug 2010

Adeona reports $979,782 net income for second-quarter 2010 vs. $879,550 net loss for same period in 2009

Adeona Pharmaceuticals, Inc. announced its second quarter 2010 financial results and recent achievements.

16 Aug 2010

Belatacept study data to be presented at 23rd International Congress of The Transplantation Society

Bristol-Myers Squibb Company announced today that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of seven oral clinical presentations related to kidney transplantation at the 23rd International Congress of The Transplantation Society, being held August 15-19, 2010, in Vancouver, British Columbia, Canada. In total, 18 abstracts from company-sponsored studies will be presented during the congress.

16 Aug 2010

Drug Trial News

AMT's MAA for LPLD gene therapy product Glybera on schedule

Lilly to halt development of potential Alzheimer's disease drug semagacestat

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

BioMarin commences Phase 3b study of Kuvan's neuropsychiatric effects in phenylketonuria patients

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

Xenon Pharmaceuticals commences phase 2 clinical trial of XEN402 therapy for PHN

Hospitals save $284 million through Premier's Quality Connect quality improvement program

Intercell reports significant increase in second quarter revenue

Key scientific work in Cardio3 BioSciences' C-Cure stem cell heart failure treatment published in JACC

Experimental drug benefits women with advanced ovarian or breast tumours caused by BRCA gene faults

Oral contraceptives equally effective for obese women

Antidepressant alleviates depression in peri- and postmenopausal women: Study

Emisphere second-quarter net loss increases to $13.7 million

Liverpool scientists create new drug for malaria

Enrollment open in Phase I clinical study of Morphotek's MORAb-028 for advanced melanoma

Titan Pharmaceuticals second-quarter net loss increases to $1.84 million

NanoViricides' anti-Herpes drug candidates demonstrate significant efficacy in cell culture studies

NIDA grants Selecta Biosciences $3M to develop nicotine vaccine for smoking cessation and relapse prevention

Adeona reports $979,782 net income for second-quarter 2010 vs. $879,550 net loss for same period in 2009

Belatacept study data to be presented at 23rd International Congress of The Transplantation Society

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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