Efficacy News and Research

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Prescription drugs prove effective in managing moderate to severe psoriasis

Clinical trials to test the effectiveness of two prescription drugs for the debilitating skin condition psoriasis have revealed significant differences that should help inform physicians treating patients with the condition.

18 Jan 2010

New discovery likely to have significant influence on cell replacement therapies

MIT neuroscientists have discovered that when it comes to new neurons in the adult brain, the squeakiest wheels get the grease.

18 Jan 2010

Scientists manipulate and expand the number of stem/progenitor cells

Scientists at Fred Hutchinson Cancer Research Center have cleared a major technical hurdle to making umbilical-cord-blood transplants a more widely-used method for treating leukemia and other blood cancers.

18 Jan 2010

Dramatically enhanced image contrast could revolutionize diagnostics and therapeutics

A Northwestern University study shows that coupling a magnetic resonance imaging (MRI) contrast agent to a nanodiamond results in dramatically enhanced signal intensity and thus vivid image contrast.

18 Jan 2010

EMA PDCO grants specific waivers for Gamida Cell-Teva JV's StemEx study in paediatric patients

The Gamida Cell-Teva Joint Venture (JV) announced today that the Paediatric Committee (PDCO) of the EMA has granted product specific waivers for StemEx for all subsets of the paediatric population (birth to 17 years of age) in all conditions. The PDCO emphasized that the granting of the waivers should not prevent the JV from considering developing StemEx for children with conditions where there is a need. StemEx is being developed by a joint venture equally owned and operated by Gamida Cell and Teva Pharmaceuticals ( TEVA).

18 Jan 2010

Atlantic examines drug-resistant TB control worldwide

The Atlantic examines the emergence of drug-resistant strains of tuberculosis around the world, with a look at the situation in South Africa. "[T]he resurgence of tuberculosis is not limited to South Africa. India and China have the largest numbers of tuberculosis cases, and multi-drug-resistant tuberculosis (MDR-TB) has been found in nearly every country, with XDR [extensively drug resistant]-TB in at least 57 countries," according to the article.

18 Jan 2010

Japan's MHLW approves InSightec's ExAblate MRgFUS system

InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's ExAblate(R) MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.

18 Jan 2010

ChromoCure publishes results of cervical cancer study using its Chromosomal Scanner Technology

ChromoCure, Inc. is pleased to announce the publication of the Cervical Cancer Study, PRE-CLINICAL SYSTEM TESTING AND PERFORMANCE ASSESSMENT, conducted in conjunction with a major international Cancer Clinic. The study analyzed samples supplied by the Cancer Clinic with its Proprietary Chromosomal Scanner Technology (full text can be found @ www.ChromoCure.com/library). The study demonstrated not only the correctness of the company's cancer detection approach but also the accuracy of the scan itself. The scanner performed perfectly with flawless detection results.

18 Jan 2010

JDRF and Animas partner to develop an automated system for better control of type 1 diabetes

The Juvenile Diabetes Research Foundation today announced an innovative partnership with Animas Corporation to develop an automated system to help people with type 1 diabetes better control their disease -- the first step on the path to what would be among the most revolutionary advancements in treating type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels.

18 Jan 2010

Cerus' INTERCEPT platelets therapeutically effective even after seven days of storage

Cerus Corporation announced today that INTERCEPT-treated platelet components were found to be effective for patient support following extended six and seven day storage in a clinical study conducted at four sites in Europe. These data further confirm the safety and therapeutic efficacy of platelets treated with the INTERCEPT Blood System, a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases.

18 Jan 2010

MediSens Wireless to begin its wireless body-monitoring system clinical trials following FDA approval

MediSens Wireless, a startup company in UCLA's on-campus technology incubator at the California NanoSystems Institute, has obtained approval under federal Food and Drug Administration guidelines to begin clinical trials on its novel wireless body-monitoring system, which assesses muscle and neuromotor functions in the upper extremities.

18 Jan 2010

CSI receives authorization to begin its pivotal trial of ORBIT II

Cardiovascular Systems, Inc. (CSI), has received Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to evaluate the safety and effectiveness of its Diamondback 360® System in the treatment of calcified coronary lesions. With this conditional approval, CSI is authorized to begin its pivotal trial, ORBIT II, in early 2010 and initially enroll up to 100 patients at as many as 50 U.S. sites.

17 Jan 2010

Results from Bionovo's phase 1B clinical trial of Bezielle published

Bionovo, Inc. announced today the publication of their results from its phase 1B clinical trial of Bezielle (BZL101) for metastatic breast cancer. The results of the study are available online in Breast Cancer Research and Treatment and demonstrate that Bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer.

17 Jan 2010

Spectros expands T-Stat product line with new Continuum Cerebral Sensor

Spectros announced today that the T-Stat® Tissue Oximeter sensor line will be expanded to include the new Continuum™ Cerebral Sensor line upon receipt of FDA marketing approval anticipated in 2010.

13 Jan 2010

Synta Pharmaceuticals presents preclinical results of STA-9090 at AACR-IASLC Joint Conference

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that preclinical results presented at the AACR-IASLC (American Academy of Cancer Research – International Association for the Study of Lung Cancer) Joint Conference based on work done at Synta and at the Dana-Farber Cancer Institute in Boston showed that STA-9090, a potent, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated potent activity against 100% of all non-small cell lung cancer cell lines tested, including those with EGFR, HER2 or KRAS mutations including the EGFR T790 mutation that is present in roughly 50% of cases of erlotinib or gefitinib resistance.

13 Jan 2010

Majority of doctors appear to ignore FDA warning to screen high-risk medications

A new study concludes that many doctors appear to have largely ignored a Food and Drug Administration warning to screen users of new antipsychotic drugs for high blood sugar and cholesterol, which poses risks to their health and raises questions about the efficacy of warning protocols in general.

13 Jan 2010

New clinical study: CeNeRx BioPharma's CXB722 has potential as novel anxiolytic

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today reported that a new clinical study shows that its investigational compound CXB722 has potential as a novel anxiolytic, demonstrating a significant effect on both endocrine and cardiovascular biomarkers associated with stress.

13 Jan 2010

BARDA invites Aeolus Pharmaceuticals to submit proposal for development of AEOL 10150

Aeolus Pharmaceuticals, Inc. announced today that after review of the Company’s white paper on development of AEOL-10150 as a countermeasure for the lung effects of acute radiation syndrome, the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Radiological and Nuclear (CBRN) Countermeasures has informed the Company that, after careful analysis and consideration, it has invited Aeolus to submit a full proposal for a contract to develop AEOL 10150 from its current level of technical readiness to FDA approval.

13 Jan 2010

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Spectrum Pharmaceuticals today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.

13 Jan 2010

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Phase II study results of the agent ASA404 showed promise in patients with either squamous or non-squamous non-small cell lung cancer (NSCLC).

13 Jan 2010

Efficacy News and Research

Prescription drugs prove effective in managing moderate to severe psoriasis

New discovery likely to have significant influence on cell replacement therapies

Scientists manipulate and expand the number of stem/progenitor cells

Dramatically enhanced image contrast could revolutionize diagnostics and therapeutics

EMA PDCO grants specific waivers for Gamida Cell-Teva JV's StemEx study in paediatric patients

Atlantic examines drug-resistant TB control worldwide

Japan's MHLW approves InSightec's ExAblate MRgFUS system

ChromoCure publishes results of cervical cancer study using its Chromosomal Scanner Technology

JDRF and Animas partner to develop an automated system for better control of type 1 diabetes

Cerus' INTERCEPT platelets therapeutically effective even after seven days of storage

MediSens Wireless to begin its wireless body-monitoring system clinical trials following FDA approval

CSI receives authorization to begin its pivotal trial of ORBIT II

Results from Bionovo's phase 1B clinical trial of Bezielle published

Spectros expands T-Stat product line with new Continuum Cerebral Sensor

Synta Pharmaceuticals presents preclinical results of STA-9090 at AACR-IASLC Joint Conference

Majority of doctors appear to ignore FDA warning to screen high-risk medications

New clinical study: CeNeRx BioPharma's CXB722 has potential as novel anxiolytic

BARDA invites Aeolus Pharmaceuticals to submit proposal for development of AEOL 10150

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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