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The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

Enrollment commences in Boehringer Ingelheim's TOviTO Phase III combination trial for COPD

Boehringer Ingelheim today announced enrolment has commenced in its TOviTO Phase III clinical trial program. It will investigate tiotropium plus olodaterol in a once-daily fixed-dose combination for the treatment of chronic obstructive pulmonary disease.

21 Sep 2011

Phenex commences Px-102 first-in-man Phase I study for Metabolic Syndrome and NAFLD

Phenex Pharmaceuticals AG announced today the start of a first-in-man Phase I study with its clinical drug candidate Px-102, a synthetic non-steroidal FXR agonist. The volunteers of the first dose level received the drug and showed no signs of discomfort or other adverse effects.

19 Sep 2011

Top-line data from Spectrum's SPI-1620 Phase 1 combination study on carcinoma

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12th International Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011. Part one of the study has been completed, while part two is ongoing.

19 Sep 2011

Spinifex initiates EMA401 Phase 2 trial in postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced the first patients have been treated in its Phase 2 clinical trial of EMA401 in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

19 Sep 2011

Enrollment commences in ConjuChem's CJC-1134-PC Phase 2 trial for Type 2 diabetes

ConjuChem, LLC, a biotechnology company dedicated to the discovery of novel therapeutics, today announced it has initiated patient enrollment for its Phase 2 clinical trial of its proprietary GLP-1 receptor agonist drug, CJC-1134-PC, in patients with Type 2 diabetes mellitus who are receiving metformin monotherapy.

15 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

Researchers create powerful anti-diabetic prototype drugs with lesser side effects

Researchers from Dana-Farber Cancer Institute in Boston and the Scripps Research Institute in Jupiter, Fla., report they have created prototype drugs having powerful anti-diabetic effects, yet apparently free - at least in mice - of dangerous side effects plaguing some current diabetes medications.

9 Sep 2011

Researchers discover mechanism of low-dose LDN on cell proliferative-related disorders

Researchers at The Pennsylvania State University College of Medicine, Hershey, Pennsylvania have discovered the mechanism by which a low dose of the opioid antagonist naltrexone (LDN), an agent used clinically to treat cancer and autoimmune diseases, exerts a profound inhibitory effect on cell proliferation.

3 Sep 2011

New guidelines for the treatment of acromegaly, a serious growth hormone disorder

It’s said a lot can happen in seven days. In seven years, a lot has happened in the understanding of acromegaly, a debilitating condition that causes a patient to have too much growth hormone. It’s seven years since the American Association of Clinical Endocrinologists last produced guidelines for the diagnosis and treatment of acromegaly. Their 2004 guidelines were just 13 pages long. Their latest, the 2011 guidelines, have grown – to 44 pages.

31 Aug 2011

Creighton pharmacology professor receives AAF's Early Excellence Award

Yaping Tu, Ph.D., associate professor of pharmacology at Creighton University School of Medicine, has received a $450,000 Early Excellence Award from the American Asthma Foundation.

31 Aug 2011

Positive results from Pearl's formoterol fumarate MDI Phase 2b trial on moderate-to-severe COPD

Pearl Therapeutics Inc. today announced positive results from a randomized, double-blind, Phase 2b, dose-ranging study of its formoterol fumarate metered dose inhaler (FF MDI; PT005), a long-acting beta-2 agonist (LABA) compared to placebo and Foradil Aerolizer in patients with moderate-to-severe COPD.

31 Aug 2011

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011

Emergent announces results of adjuvanted BioThrax anthrax vaccine Phase 1a trial

Emergent BioSolutions Inc. announced today that results from a Phase 1a clinical trial evaluating an investigational anthrax vaccine, Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant mixed at bedside, have been published in Vaccine, a leading medical journal on vaccines and immunology.

26 Aug 2011

Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., today announced that the New Drug Submission (NDS) for Lurasidone HCl, for the treatment of adult patients with schizophrenia has been accepted for review by Health Canada. The NDS was submitted to Health Canada in June 2011 and will receive a standard review.

24 Aug 2011

No effective treatment yet for acute lung injury

Patients can essentially drown in their own fluids when trauma and infection prompt blood vessels to leak, flooding millions of air sacs in their lungs.

22 Aug 2011

IRSF announces new Rett syndrome translational research awards

The International Rett Syndrome Foundation (IRSF) announced today that it is awarding over $650,000 to support eight cutting-edge projects that aim to accelerate translational research to develop treatments for Rett syndrome.

19 Aug 2011

Scientists define relationship between two prostate tumor suppressor genes

Of the 250,000 American men who will be diagnosed with prostate cancer this year, very few of them-about 1 percent-will develop lethal, metastatic disease. Finding a way to distinguish between this small cohort and the majority of patients who will develop an indolent, non-lethal form of prostate cancer is a key goal in prostate cancer research.

16 Aug 2011

Kineta's next generation antiviral program receives $2.8 million NIH SBIR grant

Kineta, Inc. announced today its next generation antiviral program has received a 2.8 million dollar grant from the National Institute of Allergy and Infectious Disease, a part of the National Institutes of Health (NIH). Awarded under the Small Business Innovation Research (SBIR) program, the prestigious phase two grant will provide on-going support for Kineta's work on a new class of antiviral drugs targeting an array of global, deadly viruses.

12 Aug 2011

GTx reports revenue of $1.6 million for second quarter 2011

GTx, Inc. today reported financial results for the second quarter of 2011. The net loss for the quarter ended June 30, 2011 was $10.7 million compared with a net loss of $12.9 million for the quarter ended June 30, 2010.

9 Aug 2011

Agonist News and Research

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Enrollment commences in Boehringer Ingelheim's TOviTO Phase III combination trial for COPD

Phenex commences Px-102 first-in-man Phase I study for Metabolic Syndrome and NAFLD

Top-line data from Spectrum's SPI-1620 Phase 1 combination study on carcinoma

Spinifex initiates EMA401 Phase 2 trial in postherpetic neuralgia

Enrollment commences in ConjuChem's CJC-1134-PC Phase 2 trial for Type 2 diabetes

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

Researchers create powerful anti-diabetic prototype drugs with lesser side effects

Researchers discover mechanism of low-dose LDN on cell proliferative-related disorders

New guidelines for the treatment of acromegaly, a serious growth hormone disorder

Creighton pharmacology professor receives AAF's Early Excellence Award

Positive results from Pearl's formoterol fumarate MDI Phase 2b trial on moderate-to-severe COPD

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Emergent announces results of adjuvanted BioThrax anthrax vaccine Phase 1a trial

Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

No effective treatment yet for acute lung injury

IRSF announces new Rett syndrome translational research awards

Scientists define relationship between two prostate tumor suppressor genes

Kineta's next generation antiviral program receives $2.8 million NIH SBIR grant

GTx reports revenue of $1.6 million for second quarter 2011

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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