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Positive results from Phase I clinical trial of GLYX-13 presented at NCDEU meeting

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that it presented data at the NCDEU 50th Anniversary Meeting showing that its novel mechanism compound GLYX-13 appeared safe in a Phase I trial. GLYX-13 is a glycine site functional partial agonist selective modulator of the NMDA receptor that is being developed initially for use in depression as adjunctive therapy.

17 Jun 2010

Neurocrine Biosciences, Boehringer Ingelheim collaborate to develop GPR119 agonists for Type II diabetes

Neurocrine Biosciences, Inc. announced today that they have established a worldwide collaboration with Boehringer Ingelheim to research and develop small molecule GPR119 agonists for the treatment of Type II diabetes and other indications. The companies will work jointly to identify and advance candidates into pre-clinical development. Boehringer Ingelheim is responsible for the global development and commercialization of potential GPR119 agonist products.

17 Jun 2010

VBL presents positive preclinical data on VB-201 for rheumatoid arthritis at EULAR

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced preclinical data demonstrating that VB-201 possesses anti-inflammatory properties and effectively reduced the symptoms of arthritis in experimental models.

17 Jun 2010

Positive Phase I results from ChemoCentryx CCX354 study for RA presented at EULAR

ChemoCentryx, Inc., today announced that it reported positive Phase I results for its novel drug candidate CCX354 at the Annual European Congress of Rheumatology (EULAR). CCX354 is the Company's orally-active small molecule drug candidate designed to specifically target the CCR1 chemokine receptor for the treatment of patients with rheumatoid arthritis (RA).

17 Jun 2010

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-76, one of two pivotal Phase 3 trials of BENLYSTA® (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The results will be presented today in Rome at the 2010 Congress of the European League Against Rheumatism (EULAR).

17 Jun 2010

Stimuvax clinical program resumed in patients with NSCLC

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that they are resuming their Stimuvax (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer which includes the Phase III studies, START and INSPIRE. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

17 Jun 2010

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

17 Jun 2010

Curis reports topline results from GDC-0449 Phase II clinical trial for metastatic colorectal cancer

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced topline results from a Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class Hedgehog pathway inhibitor. GDC-0449 was tested in combination with Avastin® (bevacizumab) and FOLFOX or FOLFIRI chemotherapy in first-line metastatic colorectal cancer patients.

17 Jun 2010

DURECT reports European POSIDUR Phase IIb hysterectomy clinical trial results

DURECT Corporation announced today results from a European Phase IIb hysterectomy clinical trial conducted by Nycomed of POSIDUR™ (also known as SABER™-bupivacaine or Optesia™ in the E.U.), a proprietary product under development for the treatment of post-surgical pain.

17 Jun 2010

The utility of observational studies in clinical decision making: Lessons learned from statin trials

An article published in the May 2010 issue of Postgraduate Medicine explains the benefits observational studies have in assessing clinical practice and thereby aid in improved processes of clinical care.

16 Jun 2010

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Trius Therapeutics, Inc. announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI).

16 Jun 2010

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

Relypsa, Inc., today announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company's lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels.

16 Jun 2010

OXiGENE completes enrollment in ZYBRESTAT Phase 2 FALCON trial for NSCLC

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has completed its targeted enrollment of 60 patients in the FALCON trial, a randomized, controlled Phase 2 study of ZYBRESTAT™ in patients with non-squamous non-small cell lung cancer (NSCLC).

16 Jun 2010

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

Horizon Pharma, Inc., announced today that data from the Phase 3 U.S. registration study of LODOTRA, a circadian cytokine modulator and novel modified-release, low-dose prednisone tablet, showed a statistically significant improvement in American College of Rheumatology response criteria in patients with rheumatoid arthritis.

16 Jun 2010

RG7204 holds promise for metastatic melanoma with V600E BRAF mutation

Preclinical findings recently published in Cancer Research, a journal of the American Association for Cancer Research, showed RG7204 (PLX4032) inhibited proliferation of tumor cell lines that expressed V600E-BRAF, a mutation found in several human cancers, including melanoma.

16 Jun 2010

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

UCB and Immunomedics Inc. announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Data presented at the European League Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEM™, showed the clinical efficacy of epratuzumab in patients with SLE.

16 Jun 2010

Nuon Therapeutics NU1618 phase 2a study in hyperuricemia meets primary endpoint

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that a phase 2a study of NU1618, the company's lead program, met its primary endpoint of reduction in serum uric acid (sUA) levels in patients with hyperuricemia.

16 Jun 2010

AVEO granted patents for tests to identify cancer patients likely to respond to tivozanib

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the issuance of U.S. Patent Nos. 7,615,353, which issued in November 2009, and 7,736,861, which issued yesterday.

16 Jun 2010

Abbott, Neurocrine enter collaboration to develop, commercialize elagolix for endometriosis-related pain

Abbott and Neurocrine Biosciences, Inc. today announced that they have entered into a collaboration agreement to develop and commercialize elagolix for the treatment of endometriosis-related pain. Elagolix is a novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which has recently completed a phase IIb study in endometriosis. In addition to endometriosis, elagolix will be evaluated for the treatment of uterine fibroids.

16 Jun 2010

Independent SMB recommends continuance of Allovectin-7 Phase 3 trial for metastatic melanoma

Vical Incorporated today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial's fourth scheduled safety analysis and recommended that the trial continue per the protocol.

16 Jun 2010

Drug Trial News

Positive results from Phase I clinical trial of GLYX-13 presented at NCDEU meeting

Neurocrine Biosciences, Boehringer Ingelheim collaborate to develop GPR119 agonists for Type II diabetes

VBL presents positive preclinical data on VB-201 for rheumatoid arthritis at EULAR

Positive Phase I results from ChemoCentryx CCX354 study for RA presented at EULAR

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

Stimuvax clinical program resumed in patients with NSCLC

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

Curis reports topline results from GDC-0449 Phase II clinical trial for metastatic colorectal cancer

DURECT reports European POSIDUR Phase IIb hysterectomy clinical trial results

The utility of observational studies in clinical decision making: Lessons learned from statin trials

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

OXiGENE completes enrollment in ZYBRESTAT Phase 2 FALCON trial for NSCLC

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

RG7204 holds promise for metastatic melanoma with V600E BRAF mutation

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

Nuon Therapeutics NU1618 phase 2a study in hyperuricemia meets primary endpoint

AVEO granted patents for tests to identify cancer patients likely to respond to tivozanib

Abbott, Neurocrine enter collaboration to develop, commercialize elagolix for endometriosis-related pain

Independent SMB recommends continuance of Allovectin-7 Phase 3 trial for metastatic melanoma

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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