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Personalized cancer vaccines can be used to marshal powerful immune response

Personalized melanoma vaccines can be used to marshal a powerful immune response against unique mutations in patients' tumors, according to early data in a first-in-people clinical trial at Washington University School of Medicine in St. Louis.

6 Apr 2015

Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

Astellas Pharma Inc. and Medivation, Inc. today announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer.

2 Apr 2015

VSV-based vaccine yields promising results for rapid development of effective Ebola vaccine

A live vaccine based on the "Vesicular Stomatitis Virus" (VSV) has yielded highly promising results for the rapid development of an effective vaccine against the Ebola virus. This vaccine would only need to be injected once for long-lasting immunoprotection.

2 Apr 2015

International researchers examine efficacy of rVSV-ZEBOV-GP Ebola vaccine

The World Health Organisation declared the Ebola virus outbreak a public health emergency in August 2014; since then the development of vaccines against Ebola virus has been fast tracked.

2 Apr 2015

Canada's VSV-EBOV Ebola vaccine proves safe, effective in Phase 1 clinical trial

The Honourable Rona Ambrose, Minister of Health, and Canada's Chief Public Health Officer, Dr. Gregory Taylor, today welcomed the news of promising trial outcomes of Canada's VSV-EBOV Ebola vaccine. The results of several studies and trials bring the world closer to ending this global outbreak through the provision of a commercially available vaccine.

2 Apr 2015

NIH approves $6.6 million in funding for Phase 2a adult eradication study of Argos' AGS-004

Argos Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis technology platform, today announced that the NIH Division of AIDS (DAIDS) has approved $6.6 million in funding for an investigator-initiated Phase 2a adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV.

2 Apr 2015

World-first human clinical trials for Hendra virus to begin this month

An antibody manufactured at The University of Queensland will be used in world-first human Hendra virus clinical trials starting this month.

1 Apr 2015

Emmaus Life Sciences presents Phase 3 clinical trial of PGLG treatment for sickle cell disease

Emmaus Life Sciences, Inc., a biopharmaceutical company dedicated primarily to the discovery, development and commercialization of innovative treatments and therapies for rare and orphan diseases today announced that data from the Company’s Phase 3 clinical trial of its pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell anemia and sickle beta-0 thalassemia, will be presented, during the 9th Annual Sickle Cell Disease Research and Educational Symposium and 38th National Sickle Cell Disease Scientific Meeting.

1 Apr 2015

PAION initiates Remimazolam Phase 3 trial in patients undergoing colonoscopy

PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of a U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy.

31 Mar 2015

Cardio3 BioSciences announces successful completion of futility analysis for C-Cure

Cardio3 BioSciences, a leader in engineered cell therapy treatments, today announced the successful completion of a futility analysis for C-Cure, its lead cell therapy for congestive heart failure, currently being evaluated in a Phase III clinical trial in Europe and Israel (CHART-1).

31 Mar 2015

Cantrixil proves highly effective at killing human ovarian stem cells in pre-clinical study

US-Australian drug discovery company, Novogen Ltd, and its subsidiary, CanTx, Inc., and Yale University, on March 27 released pre-clinical data on experimental anti-cancer drug, Cantrixil. The data was presented as an oral presentation by Professor Gil Mor MD PhD of Yale Medical School to the 62nd Annual Scientific Meeting of the Society of Reproductive Investigation in San Francisco, CA.

30 Mar 2015

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

30 Mar 2015

New faculty members join UNC Lineberger to help launch immunotherapy clinical trials

Two new faculty members have joined the UNC Lineberger Comprehensive Cancer Center to help launch groundbreaking immunotherapy clinical trials testing an experimental treatment in which patients' own immune cells are genetically engineered to fight their cancer.

30 Mar 2015

Can-Fite BioPharma's CF101Phase II/III psoriasis trial fails to meet primary endpoint

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that its Phase II/III psoriasis trial for the Company's drug candidate CF101 did not achieve its primary endpoint.

30 Mar 2015

DURECT initiates DUR-928 multi-dose Phase 1 clinical trial for NAFLD, NASH and AKI

DURECT Corporation today announced that it has initiated a multi-dose Phase 1 clinical trial of an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program.

30 Mar 2015

CASI receives CFDA approval for ENMD-2076 Phase 2 clinical trial in ovarian clear cell carcinoma

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 global clinical trial in ovarian clear cell carcinoma (OCCC) patients for its proprietary drug candidate ENMD-2076.

30 Mar 2015

Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced the initiation of a Phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI).

30 Mar 2015

Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint in the Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. In addition, a strong safety profile for the product was observed.

30 Mar 2015

Naldemedine meets primary and secondary endpoints in phase III study for OIC treatment

Naldemedine, an investigational peripherally acting mu-opioid receptor antagonist (PAMORA) under development by Shionogi & Co., Ltd., met its primary and secondary endpoints in a phase III study (COMPOSE I) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain receiving opioid therapy.

30 Mar 2015

Two experimental Ebola vaccines appear to be safe in PREVAIL clinical trial in Liberia

Two experimental Ebola vaccines appear to be safe based on evaluation in more than 600 people in Liberia who participated in the first stage of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) Phase 2/3 clinical trial, according to interim findings from an independent Data and Safety Monitoring Board review.

30 Mar 2015

Drug Trial News

Personalized cancer vaccines can be used to marshal powerful immune response

Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

VSV-based vaccine yields promising results for rapid development of effective Ebola vaccine

International researchers examine efficacy of rVSV-ZEBOV-GP Ebola vaccine

Canada's VSV-EBOV Ebola vaccine proves safe, effective in Phase 1 clinical trial

NIH approves $6.6 million in funding for Phase 2a adult eradication study of Argos' AGS-004

World-first human clinical trials for Hendra virus to begin this month

Emmaus Life Sciences presents Phase 3 clinical trial of PGLG treatment for sickle cell disease

PAION initiates Remimazolam Phase 3 trial in patients undergoing colonoscopy

Cardio3 BioSciences announces successful completion of futility analysis for C-Cure

Cantrixil proves highly effective at killing human ovarian stem cells in pre-clinical study

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

New faculty members join UNC Lineberger to help launch immunotherapy clinical trials

Can-Fite BioPharma's CF101Phase II/III psoriasis trial fails to meet primary endpoint

DURECT initiates DUR-928 multi-dose Phase 1 clinical trial for NAFLD, NASH and AKI

CASI receives CFDA approval for ENMD-2076 Phase 2 clinical trial in ovarian clear cell carcinoma

Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

Naldemedine meets primary and secondary endpoints in phase III study for OIC treatment

Two experimental Ebola vaccines appear to be safe in PREVAIL clinical trial in Liberia

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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