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VIVUS presents positive results from avanafil phase 3 study in diabetics at 47th EASD meeting

VIVUS, Inc. today presented positive results from the avanafil phase 3 study in diabetics. In the REVIVE-Diabetes study (TA-302), male diabetics receiving avanafil had significant improvement in erectile function.

14 Sep 2011

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

ViroPharma Incorporated and Halozyme Therapeutics announced today that ViroPharma has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze in combination with Halozyme's Enhanze technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme, in subjects with hereditary angioedema.

14 Sep 2011

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases today announced that it has initiated a Phase 1 clinical study of ACE-536.

14 Sep 2011

New data from Bayer's investigational oncology compounds to be presented at ECCO-ESMO congress

Bayer HealthCare announced today that the company will present data on several of its investigational compounds at the 2011 European Multidisciplinary Cancer Congress (ECCO-ESMO), September 23-27, 2011, in Stockholm, Sweden.

13 Sep 2011

Researchers use MRI and PET/CT to assess safety, efficacy of heart drug dalcetrapib

Researchers from Mount Sinai School of Medicine have for the first time used several imaging techniques to prove the efficacy of a promising new treatment for atherosclerosis—the build-up of plaque in artery walls that can lead to a heart attack.

13 Sep 2011

Positive data from NovaDigm's NDV-3 vaccine program to be presented at ICAAC conference

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced that the Company will present positive data for its NDV-3 vaccine program at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place September 17-20, 2011 in Chicago, IL.

13 Sep 2011

ImmunoCellular announces updated long-term data from ICT-107 Phase I trial on GBM

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, today announced updated long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

13 Sep 2011

Clinical trial planned in Australia and the USA to help patients with ‘orphan’ disease

Prana Biotechnology Limited announced today that researchers are planning recruitment for a phase II clinical trial of the experimental drug PBT2 in Huntington’s patients. There are currently no treatments for the genetic, neurodegenerative disease; Australia is increasingly seen as a leader in the development of therapies for neurologic disorders. Huntington’s often affects young adults and progressively impacts the body, mind and emotions. The disease causes incapacitation and death about 15-25 years after onset.

12 Sep 2011

Sanofi's Lyxumia achieves primary efficacy endpoint in study of patients uncontrolled on metformin

Sanofi announced today that Lyxumia (lixisenatide), a once-daily GLP-1 receptor agonist under development for type 2 diabetes, achieved its primary efficacy endpoint of significant HbA1c reduction vs. placebo in patients uncontrolled on metformin.

12 Sep 2011

Oncothyreon commences enrollment in PX-866 Phase 2 trial for metastatic castration-resistant prostate cancer

Oncothyreon Inc. today announced enrollment of the first patient in a Phase 2 trial of PX-866 in patients with recurrent or metastatic castration-resistant prostate cancer. PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.

12 Sep 2011

BioSante reports top-line results from LibiGel PK study for HSDD in postmenopausal women

BioSante Pharmaceuticals, Inc., today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study.

12 Sep 2011

Enrollment complete in HemaQuest HQK-1001 Phase 2 study in sickle cell disease

HemaQuest Pharmaceuticals, Inc., a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, announced today that it has completed enrollment in a randomized multi-dose Phase 2 study of HQK-1001 in patients with sickle cell disease.

12 Sep 2011

Alchemia initiates HA-Irinotecan Phase II clinical study in SCLC

Alchemia Limited, today announced the initiation of recruitment for a Phase II clinical study of its lead cancer drug HA-Irinotecan in Small Cell Lung Cancer (SCLC). Two patients have received their first doses of therapy. This investigator sponsored trial is being conducted at Monash Cancer Centre, Southern Health and Peninsula Oncology Centre in Melbourne, Victoria.

12 Sep 2011

InteRNA, Silence partner to develop novel microRNA therapeutics for cancer

Silence Therapeutics plc, a leading global RNA interference (RNAi) therapeutics company, and InteRNA Technologies B.V., a biopharmaceutical company developing pathway targeted microRNA-based therapeutics for cancer, today announce that they have entered into an agreement to develop novel microRNA therapeutics for the treatment of cancer.

12 Sep 2011

Recruitment complete in Moberg Derma's MOB-015 phase II study for nail fungus

Moberg Derma AB has successfully completed the recruitment of 237 patients with nail fungus (onychomycosis) to participate in the ongoing MOB-015 phase II study.

12 Sep 2011

Roche initiates Phase 1 clinical trial of investigational drug for Down syndrome

Roche today announced the initiation of its first Phase 1 clinical trial to investigate the safety and tolerability of a molecule designed to address the cognitive and behavioral deficits associated with Down syndrome.

12 Sep 2011

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

For the first time, a malaria vaccine that uses the entire malaria parasite has proven safe and shown promise to produce a strong immune response in a clinical trial, according to a new study co-authored by researchers at the University of Maryland School of Medicine Center for Vaccine Development.

12 Sep 2011

Nektar announces positive results from NKTR-102 Phase 2 study on metastatic breast cancer

Nektar Therapeutics announced today that positive results from the company's Phase 2 clinical study of NKTR-102 in patients with metastatic breast cancer were presented at the ASCO 2011 Breast Cancer Symposium in San Francisco, California.

12 Sep 2011

Fewer doses of Cervarix vaccine may be as efficacious as standard three-dose regimen

Fewer than three doses of the human papillomavirus (HPV) vaccine Cervarix may be just as effective as the standard three-dose regimen when it comes to preventive measures against cervical cancer, according to a new study published September 9 in the Journal of the National Cancer Institute.

9 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Drug Trial News

VIVUS presents positive results from avanafil phase 3 study in diabetics at 47th EASD meeting

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

New data from Bayer's investigational oncology compounds to be presented at ECCO-ESMO congress

Researchers use MRI and PET/CT to assess safety, efficacy of heart drug dalcetrapib

Positive data from NovaDigm's NDV-3 vaccine program to be presented at ICAAC conference

ImmunoCellular announces updated long-term data from ICT-107 Phase I trial on GBM

Clinical trial planned in Australia and the USA to help patients with ‘orphan’ disease

Sanofi's Lyxumia achieves primary efficacy endpoint in study of patients uncontrolled on metformin

Oncothyreon commences enrollment in PX-866 Phase 2 trial for metastatic castration-resistant prostate cancer

BioSante reports top-line results from LibiGel PK study for HSDD in postmenopausal women

Enrollment complete in HemaQuest HQK-1001 Phase 2 study in sickle cell disease

Alchemia initiates HA-Irinotecan Phase II clinical study in SCLC

InteRNA, Silence partner to develop novel microRNA therapeutics for cancer

Recruitment complete in Moberg Derma's MOB-015 phase II study for nail fungus

Roche initiates Phase 1 clinical trial of investigational drug for Down syndrome

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

Nektar announces positive results from NKTR-102 Phase 2 study on metastatic breast cancer

Fewer doses of Cervarix vaccine may be as efficacious as standard three-dose regimen

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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