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Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) of Munich to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.

18 Oct 2010

Cmed debuts Timaeus 5 unified eClinical platform and Timaeus HotSpot regulatory-compliant eClinical suite

Cmed Technology, an eClinical technology provider, today unveiled two product previews at two major pharmaceutical conferences. It debuted Timaeus 5, Cmed's newest version of its unified eClinical platform to manage data from Study Design through Reporting. Timaeus 5 adds enhanced usability, extended operational capabilities, streamlined investigator and monitor interaction, and expanded reporting capabilities.

18 Oct 2010

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 2a clinical trial that will evaluate multiple combinations of VX-770 and VX-809, investigational oral cystic fibrosis transmembrane conductance regulator (CFTR) modulators for the treatment of cystic fibrosis (CF). The trial is designed to evaluate the safety and tolerability of VX-809 dosed alone for 14 days followed by dosing of VX-809 in combination with VX-770 for 7 days.

18 Oct 2010

Nanotope enters agreement with Smith & Nephew to develop cartilage regeneration product

Arrowhead Research Corporation today announced that its portfolio company, Nanotope, Inc., has entered into an agreement with Smith & Nephew, Inc., a member of the Smith & Nephew plc group to develop a cartilage regeneration product for human healthcare markets using a subset of its proprietary regenerative medicine technology.

18 Oct 2010

New Trident IWR platform launched at SCDM 2010 Conference

BioClinica, Inc., a leading global provider of clinical trial management services, today announced the launch of its new IVR/IWR (interactive voice response/interactive web response) platform, Trident IWR, at the 2010 Society for Clinical Data Management Annual Conference (SCDM).

From Clario 18 Oct 2010

St. Jude Medical to acquire AGA Medical

St. Jude Medical, Inc., a global medical device company, and AGA Medical Holdings, Inc., today announced that the Boards of Directors of both companies have approved a definitive agreement under which St. Jude Medical will acquire all of the outstanding shares of AGA Medical for $20.80 per share in a cash and stock transaction valued at approximately $1.3 billion, including the assumption of approximately $225 million in outstanding debt.

18 Oct 2010

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

NovaBay Pharmaceuticals, Inc. announced today that its development partner, Alcon Research, Ltd., has concluded its proof of concept clinical trial of NovaBay's patented lead Aganocide compound, NVC-422 for the treatment of viral conjunctivitis a highly contagious eye infection for which there are currently no marketed products.

18 Oct 2010

ESHRE study shows advantages of CGH technique in IVF procedure

Two women taking part in the world's first controlled study of a comprehensive genetic screening test before IVF have given birth to healthy babies. The babies, twin girls born in Germany in June and a singleton boy born in Italy in September, are the first deliveries in a pilot study of comparative genomic hybridisation (CGH) by microarray, a new method of screening oocytes for IVF for a full range of chromosomal disorders.

18 Oct 2010

New study on Retinopathy of Prematurity

A new clinical trial at The Children's Hospital at OU Medical Center will focus on ways to catch a debilitating eye disease before it's too late.

18 Oct 2010

Researchers report progress on two eye disease challenges at AAO-MEACO 2010 Joint Meeting

At the American Academy of Ophthalmology (AAO) Middle East-Africa Council of Ophthalmology (MEACO) Joint Meeting today, researchers report progress on two top eye disease challenges treating advanced "dry" age-related macular degeneration, and preventing blindness in people with diabetes.

18 Oct 2010

Births in Italy and Germany from eggs tested by CGH

15 Oct 2010

Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

Medtronic, Inc. today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI).

15 Oct 2010

Enrollment complete in Inhibitex's FV-100 Phase II clinical trial in shingles patients

Inhibitex, Inc., announced today that it has completed enrollment in a Phase II clinical trial of FV-100 in shingles (herpes zoster) patients. The objectives of the trial are to further evaluate the safety of FV-100 and its potential therapeutic benefit in reducing the severity and duration of shingles-associated pain, the incidence of post herpetic neuralgia (PHN), and the time to heal shingles-related lesions.

15 Oct 2010

Emerging Healthcare anticipates results of FDA-approved human embryonic stem-cell treatment

Emerging Healthcare Solutions, Inc. eagerly anticipates the results of the first FDA-approved human embryonic stem-cell treatment on a patient with spinal cord injuries, which began this week.

15 Oct 2010

Merge Healthcare announces addition of four new customers for etrials myEDC solution

Merge Healthcare, a leading HIT solutions provider, today announced the addition of four new customers for its etrials myEDC solution. These wins reflect continued momentum and interest from the pharmaceutical and contract research organization community with this innovative solution.

15 Oct 2010

Enzo Biochem fiscal 2010 total revenues increase 8% to $97.1 million

Enzo Biochem, Inc. today reported results for the fiscal fourth quarter, consistent with our announcement on September 20, 2010, and for the year ended July 31, 2010.

15 Oct 2010

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

Genzyme Corporation today reported five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial. This sub-group analysis found that nearly 90 percent of alemtuzumab-treated patients were free of sustained accumulation of disability, and that patients receiving alemtuzumab also maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period.

15 Oct 2010

VertiFlex enrolls patients in Superion IDE clinical trial

VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 200 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).

15 Oct 2010

Robot-assisted brachytherapy for treating prostate cancer

In the first-of-a-kind clinical trial, a robot will be used to place therapeutic radioactive seeds in prostate cancer patients. The National Cancer Institute-supported study, which will enroll 14 patients, has just opened at Thomas Jefferson University Hospital.

15 Oct 2010

Bayhill to present BHT-3009 Phase 2 clinical trial data at European Committee Congress

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA platform to develop targeted autoimmune disease treatments, today announced that it will present at the 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis and 15th Annual Conference of Rehabilitation in MS in Gothenburg, Sweden, data from its concluded Phase 2 clinical trial showing that baseline blood plasma anti-MBP (myelin basic protein) profiles identify responders to BHT-3009 treatment.

14 Oct 2010

Clinical Trial News and Research

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Cmed debuts Timaeus 5 unified eClinical platform and Timaeus HotSpot regulatory-compliant eClinical suite

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Nanotope enters agreement with Smith & Nephew to develop cartilage regeneration product

New Trident IWR platform launched at SCDM 2010 Conference

St. Jude Medical to acquire AGA Medical

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

ESHRE study shows advantages of CGH technique in IVF procedure

New study on Retinopathy of Prematurity

Researchers report progress on two eye disease challenges at AAO-MEACO 2010 Joint Meeting

Births in Italy and Germany from eggs tested by CGH

Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

Enrollment complete in Inhibitex's FV-100 Phase II clinical trial in shingles patients

Emerging Healthcare anticipates results of FDA-approved human embryonic stem-cell treatment

Merge Healthcare announces addition of four new customers for etrials myEDC solution

Enzo Biochem fiscal 2010 total revenues increase 8% to $97.1 million

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

VertiFlex enrolls patients in Superion IDE clinical trial

Robot-assisted brachytherapy for treating prostate cancer

Bayhill to present BHT-3009 Phase 2 clinical trial data at European Committee Congress

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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