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Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

29 Mar 2010

Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Pearl Therapeutics Inc., a company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced positive results from a Phase 1 safety and pharmacokinetics study of PT003, its lead combination therapeutic for the treatment of chronic obstructive pulmonary disease (COPD). Based on these results, and previously announced positive results from Phase 2a studies of PT003's individual components, the company has advanced PT003 into a Phase 2b trial.

29 Mar 2010

Enrollment complete in Gemin X Pharmaceuticals' Phase 2 clinical trial of obatoclax for SCLC

Gemin X Pharmaceuticals, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced the completion of patient enrollment in a Phase 2 clinical trial of the Company's lead product candidate obatoclax (GX15-070) for the treatment of extensive-stage small cell lung cancer (SCLC). The trial is designed to evaluate the efficacy and safety of obatoclax, a novel pan Bcl-2 inhibitor, in combination with standard chemotherapy for the first-line treatment of patients with SCLC.

29 Mar 2010

Genta reports net loss of $11.7M for fourth-quarter 2009

Genta Incorporated today reported results for the quarter and year ended December 31, 2009. The Company also provided an overview of recent corporate highlights and anticipated milestones.

29 Mar 2010

ARYx Therapeutics reports net loss of $5.8M for fourth-quarter 2009

ARYx Therapeutics, Inc. today reported results of operations and provided an update on its products for the fourth quarter and year ended December 31, 2009.

29 Mar 2010

Medtronic announces enrollment of first European patients in randomized controlled trial of ITB Therapy

Medtronic, Inc. today announced the enrollment of the first European patients in the largest randomized controlled trial to date to investigate the benefits of ITB Therapy(R) (Intrathecal Baclofen) in post-stroke patients affected by spasticity. The announcement comes as the World Congress for Neurorehabilitation is taking place in Vienna, Austria.

26 Mar 2010

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. and Cardinal Health are working together to change that.

26 Mar 2010

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

A Cedars-Sinai Heart Institute cardiologist has been awarded a three-year, nearly $1 million grant from the Muscular Dystrophy Association (MDA) to study whether drugs used to treat erectile dysfunction could also be used to improve muscle blood flow and reduce fatigue in muscular dystrophy patients.

26 Mar 2010

NellOne's lead candidate for skeletal muscle wound healing and myocardial infarction demonstrates potential efficacy

Two key, independent proof-of-concept studies conducted for NellOne Therapeutics, Inc. demonstrate the potential efficacy of the company’s lead therapeutic candidate for both skeletal muscle wound healing and myocardial infarction.

26 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc. announced today the completion of its' pivotal Phase 2b clinical study of its oral insulin capsule, ORMD-0801. The Company expects to report results from this study within the coming weeks.

26 Mar 2010

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

Human Genome Sciences, Inc. today announced interim results through Week 12 following the end of treatment in a Phase 2b clinical trial conducted by Novartis to evaluate the safety and efficacy of ZALBIN™ (albinterferon alfa-2b), an investigational agent, administered monthly in combination with ribavirin in 391 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C virus. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Santarus, Inc., a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, as part of the budesonide MMX Phase III clinical program for U.S. registration.

26 Mar 2010

Novelos Therapeutics commences enrollment in Phase 2 trial of NOV-205 for chronic hepatitis C

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has enrolled the first patient in a U.S. Phase 2 trial evaluating NOV-205 as monotherapy in up to 40 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin.

26 Mar 2010

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Eisai Inc. announced today that the Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of the investigational compound eritoran (E5564) will continue enrolling to the preset goal of 2,000 patients. As part of a planned interim analysis, an independent Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS trial.

26 Mar 2010

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Aastrom Biosciences, Inc., a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease.

26 Mar 2010

DARA BioSciences announces the initiation of Phase I clinical study for DB959

DARA BioSciences, Inc. announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Drug Trial News

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Positive results from Pearl Therapeutics' Phase 1 study of inhaled combination bronchodilator for COPD

Enrollment complete in Gemin X Pharmaceuticals' Phase 2 clinical trial of obatoclax for SCLC

Genta reports net loss of $11.7M for fourth-quarter 2009

ARYx Therapeutics reports net loss of $5.8M for fourth-quarter 2009

Medtronic announces enrollment of first European patients in randomized controlled trial of ITB Therapy

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

NellOne's lead candidate for skeletal muscle wound healing and myocardial infarction demonstrates potential efficacy

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Novelos Therapeutics commences enrollment in Phase 2 trial of NOV-205 for chronic hepatitis C

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

DARA BioSciences announces the initiation of Phase I clinical study for DB959

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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