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Seattle Genetics reports SGN-75 phase I clinical trial data

Seattle Genetics, Inc. today reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

UT Southwestern initiates study on hormone leptin for people with type 1 diabetes

A clinical trial at UT Southwestern Medical Center aims to determine whether adding the hormone leptin to standard insulin therapy might help rein in the tumultuous blood-sugar levels of people with type 1 (insulin-dependent) diabetes.

11 Oct 2010

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

A drug being developed as a treatment for ovarian cancer has shown single agent activity with durable disease control in some patients in a Phase-II clinical trial, an international research group has reported.

11 Oct 2010

FDA designates NeuRx Diaphragm Pacing System as HUD device for ALS patients

Synapse Biomedical Inc. announces today that they have received the U.S. Food and Drug Administration (FDA) designation of the NeuRx Diaphragm Pacing System (DPS) as a Humanitarian Use Device (HUD) for amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm who are experiencing chronic hypoventilation and has now submitted for Humanitarian Device Exemption (HDE) approval.

11 Oct 2010

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Infinity Pharmaceuticals, Inc. today announced promising preliminary results from a Phase 1 study of IPI-926, its novel, oral small molecule that targets the Hedgehog pathway.

11 Oct 2010

Defense Department's AFIRM to fund Stratatech's Phase IIb clinical trial of StrataGraft tissue

Stratatech Corp., a regenerative medicine company focused on the commercialization of cell-based, tissue-engineered skin substitute products, today announced that the Defense Department's Armed Forces Institute of Regenerative Medicine will fund the Phase IIb clinical trial of the company's flagship StrataGraft living human skin substitute tissue.

8 Oct 2010

Abiraterone Phase III clinical data to be presented at ESMO meeting

Attendees at next week's European Society of Medical Oncology (ESMO) meeting in Milan will be presented with top-line Phase III Clinical Trials data on Abiraterone in the treatment of castration-resistant prostate cancer.

8 Oct 2010

StemCells provides update on PMD Phase I clinical trial

StemCells, Inc. today provided an update on its ongoing Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), a fatal myelination disorder that afflicts male children.

8 Oct 2010

Two-day symposium marks an extraordinary decade for Brown Institute for Brain Science

Just as intense concentration allows a sharp mind to perform at its peak, a research institute that concentrates pre-eminent scientists from 11 academic departments can push back the frontiers of knowledge in a complex research area: the human brain.

8 Oct 2010

Innovative trial designs may improve efficiency of clinical trials

Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.

8 Oct 2010

Emergent BioSolutions and TLV form new joint venture to develop flu vaccines

Emergent BioSolutions Inc., a U.S.-based developer and manufacturer of vaccines and antibody therapies, today launched its Singapore operations.

8 Oct 2010

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) candidates for the treatment of cancer, respiratory and inflammatory diseases, announced today results from its randomized, placebo controlled clinical trial evaluating VTX-1463 for the treatment of allergic rhinitis.

8 Oct 2010

Phase 3 study of D-tagatose in Type 2 diabetes shows significant reduction in HbA1c levels

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 3 study of D-tagatose as a monotherapy in Type 2 diabetes showed a statistically significant (p<0.05) reduction in HbA1c levels of 0.4% at 10 months in relatively healthy people with diabetes

8 Oct 2010

NIAID announces three new contracts to fund research on dengue, anthrax vaccines

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats that could be used in a terror attack. Each project focuses on simple and efficient vaccine delivery approaches that could be deployed quickly. The total funding for the three contracts could reach $68 million, depending on the successful completion of defined project milestones.

8 Oct 2010

Inviragen, PharmaJet awarded NIAID contract to develop needle-free, easy to administer dengue vaccine

Inviragen and PharmaJet announced the award of a five year, $15.5 million dollar contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to advance the development of a needle-free, easy to administer dengue vaccine. The award will fund preclinical studies, regulatory filings, manufacturing and clinical testing of Inviragen's tetravalent dengue vaccine, DENVax delivered with PharmaJet's convenient needle-free injection device.

8 Oct 2010

Genzyme board of directors vote to reject tender offer from Sanofi-Aventis

Genzyme Corp. announced today that its board of directors has voted unanimously to reject the unsolicited $69.00 per share tender offer from Sanofi-Aventis, and the board recommends that Genzyme shareholders not tender their shares to Sanofi-Aventis pursuant to the offer.

8 Oct 2010

Biomoda extends pilot clinical trial of CyPath assay for early-stage lung cancer detection

Cancer diagnostics company Biomoda, Inc. today announced in its new monthly President's Column, posted at www.biomoda.com, that it is extending the pilot clinical trial of its CyPath diagnostic assay for the detection of early-stage lung cancer to recruit additional participants for the positive control group, patients who have been diagnosed with lung cancer but have not yet begun treatment for the disease.

8 Oct 2010

Researchers develop new technique to detect lung cancer

Early detection is critical for improving cancer survival rates. Yet, one of the deadliest cancers in the United States, lung cancer, is notoriously difficult to detect in its early stages.

8 Oct 2010

Clinical Trial News and Research

Seattle Genetics reports SGN-75 phase I clinical trial data

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

UT Southwestern initiates study on hormone leptin for people with type 1 diabetes

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

FDA designates NeuRx Diaphragm Pacing System as HUD device for ALS patients

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Defense Department's AFIRM to fund Stratatech's Phase IIb clinical trial of StrataGraft tissue

Abiraterone Phase III clinical data to be presented at ESMO meeting

StemCells provides update on PMD Phase I clinical trial

Two-day symposium marks an extraordinary decade for Brown Institute for Brain Science

Innovative trial designs may improve efficiency of clinical trials

Emergent BioSolutions and TLV form new joint venture to develop flu vaccines

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

Phase 3 study of D-tagatose in Type 2 diabetes shows significant reduction in HbA1c levels

NIAID announces three new contracts to fund research on dengue, anthrax vaccines

Inviragen, PharmaJet awarded NIAID contract to develop needle-free, easy to administer dengue vaccine

Genzyme board of directors vote to reject tender offer from Sanofi-Aventis

Biomoda extends pilot clinical trial of CyPath assay for early-stage lung cancer detection

Researchers develop new technique to detect lung cancer

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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