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Final analysis of AVEO's tivozanib Phase 2 trial on kidney cancer patients presented at ASCO 2011

AVEO Pharmaceuticals, Inc., today announced data from the final analysis of its Phase 2 randomized discontinuation trial evaluating tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in patients with advanced renal cell carcinoma.

2 Jun 2011

Positive interim results from Fraunhofer USA CMB's HAC1 influenza vaccine Phase 1 trial

Fraunhofer USA Center for Molecular Biotechnology, a not-for-profit, Delaware-based organization focused on developing a proprietary plant-based protein production platform and its applications in vaccine and therapeutic fields, today announced positive interim results from the first human trial of plant-produced H1N1 influenza vaccine that began on September 13, 2010.

2 Jun 2011

Somnus Therapeutics completes SKP-1041 Phase 2 trial against sleep maintenance insomnia

Somnus Therapeutics, Inc., a private specialty pharmaceutical company, has completed a Phase 2 dose-ranging study of SKP-1041, a modified-release formulation of zaleplon.

2 Jun 2011

Lymphoma vaccine extends disease-free survival by 14 months

A lymphoma vaccine uniquely tailored for each patient extends disease-free survival by 14 months, with signs of an even better response for patients with a specific biological marker, a team led by scientists at The University of Texas MD Anderson Cancer Center reported today in the online version of Journal of Clinical Oncology.

1 Jun 2011

Diamyd European Phase III study in diabetes does not meet primary endpoint

Diamyd Medical AB reports that the Company has decided not to complete the follow-up period of a European Phase III study with the antigen-based therapy Diamyd.

1 Jun 2011

CrystalGenomics begins enrollment in CG100649 Phase 2b osteoarthritis study

CrystalGenomics, Inc. and CG Pharmaceuticals, Inc., a biopharmaceutical company with 3 clinical stage candidates, has announced that the first patient has been enrolled for a Phase 2b clinical study of CG100649, CrystalGenomics' clinical stage novel NSAID candidate, in patients with knee or hip osteoarthritis.

1 Jun 2011

Rochester receives $1M FDA, BDRSA grant to begin first controlled clinical trial in Juvenile Batten disease

After years of building hope for a treatment, Rochester researchers and clinicians will begin the first controlled clinical trial for Juvenile Batten disease this summer, thanks to $1 million in grants from the Food and Drug Administration and the Batten Disease Support and Research Association.

1 Jun 2011

Ampio commences new anti-inflammatory agent Phase 1B trial in osteoarthritis

Ampio Pharmaceuticals, Inc. announced today that it received ethics board approval for a Phase 1B clinical trial in Australia of its biologic anti-inflammatory agent, Ampion.

1 Jun 2011

Enrollment complete in BioSante's LibiGel Phase III cardiovascular and breast cancer safety study

BioSante Pharmaceuticals, Inc., today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.

31 May 2011

FDA approves Oceana's Solesta for treatment of fecal incontinence

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, announced that the U.S. Food and Drug Administration has approved Solesta as a treatment for fecal incontinence in adult patients who have failed conservative therapy such as dietary control.

31 May 2011

New positive Cimzia phase IIIb study data on rheumatoid arthritis presented at EULAR meeting

UCB today announced data which showed that the addition of Cimzia to current therapy was associated with a rapid and consistent clinical response in a diverse group of rheumatoid arthritis (RA) patients.

30 May 2011

Efficacy of Abbott cholesterol drug in question

A latest study has found that using medication to raise good cholesterol while lowering the bad does NOT translate into fewer adverse cardiovascular events like heart attacks and strokes. The study was revealed Thursday by the National Institutes of Health and it found that high dosages of Abbott Laboratories' Niaspan failed to prevent heart attacks and boosted the likelihood of a stroke when combined with the popular generic cholesterol pill Simvastatin, also known under the brand name Zocor.

29 May 2011

NHLBI stops AIM-HIGH combination clinical trial in high blood cholesterol

The National Heart, Lung, and Blood Institute of the National Institutes of Health has stopped a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.

27 May 2011

ARCA plans to expand development program for Gencaro in atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it is planning to expand the development of Gencaro, its lead cardiovascular drug candidate, to atrial fibrillation, a disease that affects more than 2.4 million patients in the United States.

27 May 2011

Abiraterone acetate effective for men with advanced prostate cancer

A drug recently approved by the Food & Drug Administration for the treatment of prostate cancer is proving to give some patients the gift of time. A new study shows abiraterone acetate extends the lives of men with the most advanced form of the disease by about four months.

27 May 2011

Omega-3 fatty acids reduce risk of heart attack in stent patients

Omega-3 fatty acids, combined with two blood-thinning drugs, significantly changed the blood-clotting process and may reduce the risk of heart attacks in patients with stents in their heart arteries, according to research reported in Arteriosclerosis, Thrombosis and Vascular Biology: Journal of the American Heart Association.

27 May 2011

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

MAP Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application to the United States Food and Drug Administration for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults.

27 May 2011

BioCryst presents positive data from two BCX4208 Phase 2 studies in gout at EULAR 2011

BioCryst Pharmaceuticals, Inc. presented positive data from its two completed, randomized, double-blind, placebo-controlled Phase 2 studies of BCX4208 in patients with gout at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism in London, U.K.

26 May 2011

Mayoly-Spindler, ProteaBio complete MS1819 Phase I/IIA trial in malabsorption syndrome

ProteaBio Europe SAS, announced today that the company, in partnership with Mayoly-Spindler, has successfully completed a Phase I/IIA human clinical trial for their MS1819 recombinant Lipase.

26 May 2011

Boehringer Ingelheim's new afatinib-cetuximab phase Ib data in NSCLC presented at ASCO 2011

Boehringer Ingelheim Pharmaceuticals, Inc. will present new phase Ib data at the 2011 American Society of Clinical Oncology annual meeting in Chicago that indicates combining its investigational therapy afatinib with cetuximab at the maximum tested dose controlled disease in all (n=22) treated epidermal growth factor receptor (EGFR)-mutation positive patients with non-small cell lung cancer who developed acquired resistance to treatment with a reversible EGFR tyrosine kinase inhibitor.

26 May 2011

Placebo News and Research

Final analysis of AVEO's tivozanib Phase 2 trial on kidney cancer patients presented at ASCO 2011

Positive interim results from Fraunhofer USA CMB's HAC1 influenza vaccine Phase 1 trial

Somnus Therapeutics completes SKP-1041 Phase 2 trial against sleep maintenance insomnia

Lymphoma vaccine extends disease-free survival by 14 months

Diamyd European Phase III study in diabetes does not meet primary endpoint

CrystalGenomics begins enrollment in CG100649 Phase 2b osteoarthritis study

Rochester receives $1M FDA, BDRSA grant to begin first controlled clinical trial in Juvenile Batten disease

Ampio commences new anti-inflammatory agent Phase 1B trial in osteoarthritis

Enrollment complete in BioSante's LibiGel Phase III cardiovascular and breast cancer safety study

FDA approves Oceana's Solesta for treatment of fecal incontinence

New positive Cimzia phase IIIb study data on rheumatoid arthritis presented at EULAR meeting

Efficacy of Abbott cholesterol drug in question

NHLBI stops AIM-HIGH combination clinical trial in high blood cholesterol

ARCA plans to expand development program for Gencaro in atrial fibrillation

Abiraterone acetate effective for men with advanced prostate cancer

Omega-3 fatty acids reduce risk of heart attack in stent patients

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

BioCryst presents positive data from two BCX4208 Phase 2 studies in gout at EULAR 2011

Mayoly-Spindler, ProteaBio complete MS1819 Phase I/IIA trial in malabsorption syndrome

Boehringer Ingelheim's new afatinib-cetuximab phase Ib data in NSCLC presented at ASCO 2011

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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