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Study shows lower success rate of FDA drug approval from 2003 to 2010

Biotechnology Industry Organization Industry Analysis and BioMedTracker announced results of a study today that shows the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previous reports, taken from earlier years, showed the rate of drug approvals is one in five to one in six.

15 Feb 2011

Screening breast MRIs can detect invasive cancers in women with history of chest irradiation

Breast cancer screening with MRI can detect invasive cancers missed on mammography in women who've undergone chest irradiation for other diseases, according to a new study published online and in the April print edition of Radiology.

15 Feb 2011

U-Systems completes pivotal study for automated breast ultrasound cancer screening

U-Systems, the leader in automated breast ultrasound today announced the completion of a pivotal ROC Reader Study for automated breast ultrasound cancer screening. Conducted by University of Chicago, an acclaimed pioneer in women's heath research, the multi-reader, multi-case (MRMC) ROC Reader Study was carried-out to evaluate the sensitivity of somo•v™ Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue.

14 Feb 2011

Chimerix announces completion of $45 million Series F financing

Chimerix, Inc., a pharmaceutical company developing orally-available broad spectrum antiviral therapeutics, today announced the completion of a $45 million Series F financing. New Leaf Venture Partners led the round, with participation by new investors Pappas Ventures and Morningside Group, as well as existing investors Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.

14 Feb 2011

BioTime to merge Glycosan with OrthoCyte

BioTime, Inc., a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced it has signed a definitive agreement to merge Utah-based Glycosan BioSystems, Inc. (Glycosan) with BioTime's wholly-owned subsidiary, OrthoCyte Corporation. The acquisition is expected to close by March 18, 2011.

14 Feb 2011

Neoprobe achieves accrual goal in Lymphoseek Phase 3 study in breast cancer/melanoma

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a multi-center Phase 3 study of Lymphoseek® has enrolled clinical subjects to achieve the minimum analysis goal of 196 lymph nodes, the study's primary accrual objective.

14 Feb 2011

PROLOR reports positive DSMB review of long-acting human growth hormone clinical trial

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported that patient enrollment and dosing in the Phase II trial of its long-acting version of human growth hormone (hGH-CTP) are proceeding according to plan, with study completion targeted for mid-year 2011.

14 Feb 2011

Tarsa completes oral calcitonin Phase III trial for treatment of postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced completion of its global Phase III ORACAL trial testing the company's once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis. Results from the ORACAL trial are expected in early spring. In addition, Tarsa announced initiation of a new Phase II study of its oral calcitonin for the prevention of postmenopausal osteoporosis.

14 Feb 2011

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has entered into a Cooperative Research and Development Agreement with the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) to collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer.

14 Feb 2011

Numira acquires Ricerca' Efficacy Pharmacology operating unit

Numira Biosciences, a specialty contract research organization and leader in high resolution, 3D imaging services and visualization software for the life science market, announced today that it has acquired the Efficacy Pharmacology operating unit of Ricerca Biosciences, LLC., located in Bothell, WA.

14 Feb 2011

Oestrogen reduces risk of breast cancer: Study

A team of researchers at CIC bioGUNE has revealed that oestrogen can reduce the risk of breast cancer. Their work shows that oestrogen is capable of reducing the number of breast cancer stem cells, which may explain the lower aggression of the tumour and, as a consequence, the possibility of a better prognosis.

14 Feb 2011

BioCentury features ImmunGene's interferon payload technology and cancer antibodies

ImmunGene, Inc., a privately held drug development company focused on targeted antibody therapeutics, announced today that a profile of the company and its interferon payload technology platform and drug discovery pipeline is featured in the February 7 issue of BioCentury, one of the most widely read publications in the pharma and biotech industries.

14 Feb 2011

Last patient in EU Diamyd Phase III clinical study completes 15-month visit for type 1 diabetes

The last patient in the EU Diamyd Phase III clinical study has completed the 15-month visit, meaning that all patients in this study have completed the main 15 month study period in this trial. This important achievement in the Diamyd® Phase III program will now be followed by an intense period where the data will be compiled from the more than 60 clinics throughout Europe and from the central laboratory.

14 Feb 2011

The Lancet publishes CHAMPION trial results against heart failure

The CHAMPION clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment.

14 Feb 2011

JTH publishes positive TB-402 Phase II trial results for VTE treatment after orthopaedic surgery

ThromboGenics NV and co-development partner BioInvent International announce today that the positive TB-402 Phase II trial results, evaluating the product's efficacy and safety for the prevention of venous thromboembolism afterorthopaedic surgery, have been published in the Journal of Thrombosis and Haemostasis.

14 Feb 2011

Scientists produce SR-3306 compound to protect brain cells from Parkinson's disease

Scientists from the Florida campus of The Scripps Research Institute have produced the first known compound to show significant effectiveness in protecting brain cells directly affected by Parkinson's disease, a progressive and fatal neurodegenerative disorder.

13 Feb 2011

Positive safety data from BioSante's ongoing LibiGel Phase III study in women with HSDD

BioSante Pharmaceuticals, today announced positive safety data in its ongoing LibiGel Phase III clinical development program.

13 Feb 2011

BIDPO implements Ingenix technology to measure clinical, operational performance

Beth Israel Deaconess Physician Organization (BIDPO) has contracted with Ingenix to help its doctors measure clinical performance to reduce variations in care - capabilities essential to BIDPO's plans to operate successfully under anticipated state and national payment reform changes.

11 Feb 2011

Pyrethroid insecticides linked to delayed mental development in children

When the EPA phased out the widespread residential use of chlorpyrifos and other organophosphorus (OP) insecticides in 2000-2001 because of risks to child neurodevelopment, these compounds were largely replaced with pyrethroid insecticides. But the safety of these replacement insecticides remained unclear, as they had never been evaluated for long-term neurotoxic effects after low-level exposure.

11 Feb 2011

Sorin's 2010 consolidated revenues increase 4.9% to € 745.8 million

The Board of Directors of Sorin S.p.A. meeting today under the chairmanship of Rosario Bifulco reviewed the fourth quarter 2010 and the preliminary 2010 consolidated results.

11 Feb 2011

Efficacy News and Research

Study shows lower success rate of FDA drug approval from 2003 to 2010

Screening breast MRIs can detect invasive cancers in women with history of chest irradiation

U-Systems completes pivotal study for automated breast ultrasound cancer screening

Chimerix announces completion of $45 million Series F financing

BioTime to merge Glycosan with OrthoCyte

Neoprobe achieves accrual goal in Lymphoseek Phase 3 study in breast cancer/melanoma

PROLOR reports positive DSMB review of long-acting human growth hormone clinical trial

Tarsa completes oral calcitonin Phase III trial for treatment of postmenopausal osteoporosis

OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

Numira acquires Ricerca' Efficacy Pharmacology operating unit

Oestrogen reduces risk of breast cancer: Study

BioCentury features ImmunGene's interferon payload technology and cancer antibodies

Last patient in EU Diamyd Phase III clinical study completes 15-month visit for type 1 diabetes

The Lancet publishes CHAMPION trial results against heart failure

JTH publishes positive TB-402 Phase II trial results for VTE treatment after orthopaedic surgery

Scientists produce SR-3306 compound to protect brain cells from Parkinson's disease

Positive safety data from BioSante's ongoing LibiGel Phase III study in women with HSDD

BIDPO implements Ingenix technology to measure clinical, operational performance

Pyrethroid insecticides linked to delayed mental development in children

Sorin's 2010 consolidated revenues increase 4.9% to € 745.8 million

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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