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Sagene completes SPI-1972 pre-IND meeting with FDA for erectile dysfunction

Sagene Pharmaceuticals, Inc., a biopharmaceutical company focused on developing combinations of FDA-approved drugs to treat diseases associated with aging, has completed a pre-IND meeting with the Division of Reproductive and Urologic Products of the FDA to discuss the development plan for SPI-1972, a dual-action combination treatment for erectile dysfunction.

9 Sep 2011

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

Positive results from the initial Phase 1 clinical trial in 80 healthy volunteers and complementary pre-clinical studies of the Sanaria PfSPZ Vaccine are published today in the online issue of Science.

9 Sep 2011

OptiNose chooses BioClinica's advanced imaging and IWR solutions for clinical trials

BioClinica, Inc., a global provider of clinical trial management solutions, today announced that OptiNose, Inc. selected BioClinica Trident IWR, Optimizer clinical supplies forecasting, and Imaging Core Lab services for use in a series of clinical trials including several pivotal Phase III studies.

From Clario 8 Sep 2011

Lilly, Boehringer Ingelheim to present latest data from diabetes portfolio at 47th EASD meeting

Boehringer Ingelheim and Eli Lilly and Company will present the latest data from their diabetes portfolio at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal, September 12-16.

8 Sep 2011

Better communication needed with at-risk communities for HIV vaccine trials

Better communication is needed around HIV vaccine trials to ensure those in at-risk communities understand the process and continue to participate, according to a new University of Toronto study.

8 Sep 2011

Adding azithromycin to usual daily treatment for COPD reduces acute exacerbations by 27%

Richard Casaburi, Ph.D., M.D., principal investigator at Los Angeles Biomedical Research Institute (LA BioMed), is co-author of a recent study that should help improve the condition for the millions of individuals who suffer from chronic obstructive pulmonary disease, better known as COPD.

8 Sep 2011

Top-line results from Teva-Alcobra MG01CI Phase II trial for ADHD

Teva Pharmaceutical Industries Ltd. and Alcobra Ltd. announced today top-line results from a six week, randomized, placebo-controlled, Phase II multi-center study designed to assess the safety and efficacy of MG01CI in adults with attention deficit hyperactivity disorder (ADHD).

7 Sep 2011

Ardea Biosciences reports positive outcome from lesinurad End-of-Phase 2 meetings with FDA

Ardea Biosciences, Inc. announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and successfully reached agreement on the following key aspects of its proposed lesinurad Phase 3 development plan: the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, manufacturing plans for both drug substance and drug product, the preclinical toxicology program and the clinical pharmacology program.

7 Sep 2011

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results from a pilot clinical study to assess safety, tolerability, and multiple-dose pharmacokinetics of XIAFLEX (collagenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple palpable cords.

7 Sep 2011

Cancer Research UK opens olaparib-temozolomide combination Phase I trial in glioblastoma

Cancer Research UK's Drug Development Office has opened a trial of a new combination of drugs for the treatment of patients with brain cancer.

7 Sep 2011

ImmunoCellular provides update on ICT-107 Phase II trial for glioblastoma multiforme

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, provided an update today on clinical trial site activity and patient enrollment for its Phase II clinical trial of ICT-107, the Company's dendritic cell based cancer vaccine candidate targeting multiple tumor antigens for the treatment of glioblastoma multiforme.

7 Sep 2011

GSK receives HHS' BARDA contract to support development of Gram-negative antibiotic, GSK2251052

Anacor Pharmaceuticals announced today that its partner, GlaxoSmithKline (GSK), has been awarded a contract with the U.S. Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority (BARDA) to support the ongoing development of GSK2251052 (GSK '052, formerly AN3665), a novel boron-based Gram-negative systemic antibiotic discovered by Anacor.

7 Sep 2011

Leading cancer journals publish OncoGenex's custirsen pre-clinical and Phase II study data

OncoGenex Pharmaceuticals, Inc. announced today that data from two studies, a Phase II clinical study and a pre-clinical study, evaluating the investigational compound custirsen, were published in the September issues of the journals Clinical Cancer Research and Cancer Research.

7 Sep 2011

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.

6 Sep 2011

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

DURECT Corporation announced today the dosing of the last patient in the U.S. pivotal Phase III clinical study for POSIDUR known as BESST.

6 Sep 2011

Vertex VX-509 12-week Phase 2a study on RA meets two primary endpoints

Vertex Pharmaceuticals Incorporated today announced that treatment with the investigational selective oral JAK3 inhibitor VX-509 in a Phase 2a trial resulted in substantial and statistically significant improvements in multiple measurements of rheumatoid arthritis (RA) activity.

6 Sep 2011

Shiva Biomedical, CorMedix to extend CRMD001 phase III trial in chronic kidney disease

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced it has amended its agreement with Shiva Biomedical, LLC.

6 Sep 2011

ICS, Quintiles enter agreement with Pacira to support launch of EXPAREL

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that it has entered into agreements with Quintiles Commercial US, Inc. and Integrated Commercialization Services, Inc. (ICS) to support the anticipated launch of EXPAREL, should it be approved by the Food and Drug Administration (FDA) later this year.

6 Sep 2011

Pharmasset reports SVR results from PSI-7977 phase 2b combination study on HCV genotype 1

Pharmasset, Inc., announced today sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 400 mg dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 1 who have not been treated previously. 43 out of 44 (98%) evaluable subjects achieved an SVR12, defined as HCV RNA below the limit of detection (<15 IU/mL) 12 weeks after the completion of treatment.

6 Sep 2011

NOXXON to commence NOX-H94 Phase I trial in anemia of chronic disease

NOXXON Pharma today announced the initiation of a Phase I clinical trial for NOX-H94, the Company's third compound to enter the clinic. NOX-H94 is a Spiegelmer designed to treat anemia of chronic disease by targeting the peptide hormone hepcidin, the key regulator of iron metabolism.

6 Sep 2011

Drug Trial News

Sagene completes SPI-1972 pre-IND meeting with FDA for erectile dysfunction

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

OptiNose chooses BioClinica's advanced imaging and IWR solutions for clinical trials

Lilly, Boehringer Ingelheim to present latest data from diabetes portfolio at 47th EASD meeting

Better communication needed with at-risk communities for HIV vaccine trials

Adding azithromycin to usual daily treatment for COPD reduces acute exacerbations by 27%

Top-line results from Teva-Alcobra MG01CI Phase II trial for ADHD

Ardea Biosciences reports positive outcome from lesinurad End-of-Phase 2 meetings with FDA

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Cancer Research UK opens olaparib-temozolomide combination Phase I trial in glioblastoma

ImmunoCellular provides update on ICT-107 Phase II trial for glioblastoma multiforme

GSK receives HHS' BARDA contract to support development of Gram-negative antibiotic, GSK2251052

Leading cancer journals publish OncoGenex's custirsen pre-clinical and Phase II study data

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

Vertex VX-509 12-week Phase 2a study on RA meets two primary endpoints

Shiva Biomedical, CorMedix to extend CRMD001 phase III trial in chronic kidney disease

ICS, Quintiles enter agreement with Pacira to support launch of EXPAREL

Pharmasset reports SVR results from PSI-7977 phase 2b combination study on HCV genotype 1

NOXXON to commence NOX-H94 Phase I trial in anemia of chronic disease

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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