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Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Allos Therapeutics, Inc. today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company's Phase 3 clinical trial of FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).

4 Mar 2011

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

3 Mar 2011

VICC introduces nation's first personalized cancer decision support tool

Vanderbilt-Ingram Cancer Center has launched the nation's first personalized cancer decision support tool, "My Cancer Genome," to help physicians and researchers track the latest developments in personalized cancer medicine and connect with clinical research trials for their patients.

3 Mar 2011

Genetics and cancer research

The 20th century was dominated by breakthroughs in physics and chemistry, but the 21st century will belong to genetics and biotechnology. Cancer research is just one area among many that is being transformed by the sequencing of the human genome. This was one of the topics discussed in our recent panel with leading cancer researchers, part of our Breakthroughs: Cancer series.

3 Mar 2011

Clinical trials in Australia take too long– need uniform standards: Report

A government report says that clinical trials for new medicines are taking too long and should be sped up so patients can access urgently needed treatment. The states and territories have been urged to adopt uniform rules on approving trials so the scientific experiments can be conducted more efficiently and effectively.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

Positive outcomes from Argos AGS-004 Phase 2a trial in patients with HIV

Argos Therapeutics announced today that its Arcelis immunotherapy for the treatment of HIV, AGS-004, demonstrated positive outcomes with the primary endpoint of viral load control and a favorable safety and immunogenicity profile in a final analysis of a Phase 2a clinical trial.

3 Mar 2011

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Depomed, Inc. announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada for the non-hormonal treatment of menopausal hot flashes.

3 Mar 2011

Lixte receives $244,479.25 U.S. government grant for QTDP program

Lixte Biotechnology Holdings announced today that the company has received a $244,479.25 grant under the Qualifying Therapeutic Discovery Project.

3 Mar 2011

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

EpiCept Corporation today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia patients in its previous Phase III trial with Ceplene administered with low-dose interleukin-2.

3 Mar 2011

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Osiris Therapeutics, Inc., today announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal, an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack.

3 Mar 2011

Cyberonics third quarter net sales increase 15.3% to $47.1 million

Cyberonics, Inc., a global leader in epilepsy management, today announced results for the quarter ended January 28, 2011.

2 Mar 2011

Novabay commences NVC-422 catheter Phase 2 trial to treat UCBE

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, today provided an update on its Phase 2 clinical trial for the use of its lead compound, NVC-422, to prevent urinary catheter blockage and encrustation which is often a contributing factor to urinary tract infections in chronically catheterized patients.

2 Mar 2011

Achillion fourth quarter revenue is $2 million for three months ended December 31, 2010

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported financial results for the three and twelve months ended December 31, 2010.

2 Mar 2011

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

GTx, Inc. today announced that the company and Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.

2 Mar 2011

NEI/FDA conference to analyze functional vision outcomes from clinical trials of visual prostheses

The National Eye Institute and Food and Drug Administration are sponsoring a conference to determine how functional vision-related endpoints for clinical trials of visual prostheses will be analyzed and correlated with objective measures of visual acuity, visual fields and contrast sensitivity.

2 Mar 2011

DMC CVI completes the first two transcatheter aortic valve implants in Michigan

The Detroit Medical Center (DMC) Cardiovascular Institute (CVI) has completed the first two transcatheter aortic valve implants (TAVI) ever achieved in Michigan. The procedures are a part of CVI's participation in the Medtronic CoreValve® U.S. Clinical Trial. This multi-state trial will evaluate a new, non-surgical alternative to open-heart surgery for patients with severe aortic stenosis.

2 Mar 2011

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

In 2010, Group drug sales grew 5.1% year-on-year - at constant currency - exceeding the objective set a year ago of 3.0% to 5.0%, fuelled notably by the sales of Specialty Care products throughout all the geographical regions where the Group operates.

2 Mar 2011

Health benefits of herbal teas no longer a folklore

Those who enjoy the caffeinated lift that comes from drinking traditional coffees and teas may tend to overlook the benefits of drinking herbal infusions. Now, as explained in this month's issue of Agricultural Research magazine, the idea that herbal teas may provide a variety of health benefits is no longer just folklore.

2 Mar 2011

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Neuralstem, Inc. announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.

2 Mar 2011

Clinical Trial News and Research

Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

VICC introduces nation's first personalized cancer decision support tool

Genetics and cancer research

Clinical trials in Australia take too long– need uniform standards: Report

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Positive outcomes from Argos AGS-004 Phase 2a trial in patients with HIV

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Lixte receives $244,479.25 U.S. government grant for QTDP program

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Cyberonics third quarter net sales increase 15.3% to $47.1 million

Novabay commences NVC-422 catheter Phase 2 trial to treat UCBE

Achillion fourth quarter revenue is $2 million for three months ended December 31, 2010

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

NEI/FDA conference to analyze functional vision outcomes from clinical trials of visual prostheses

DMC CVI completes the first two transcatheter aortic valve implants in Michigan

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

Health benefits of herbal teas no longer a folklore

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

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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