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Most patients with depression excluded from antidepressant trials, study finds

More than 80 percent of people with depression in the general population aren't eligible for clinical trials of antidepressant drugs, according to a study in the Journal of Psychiatric Practice.

15 Jul 2015

Isis Pharmaceuticals receives $2.15 million milestone payment to advance ISIS-SMN Rx study in children with SMA

Isis Pharmaceuticals, Inc. announced today that it has earned a $2.15 million milestone payment from Biogen related to advancing the ongoing pivotal Phase 3 study (CHERISH) evaluating ISIS-SMN Rx in children with spinal muscular atrophy (SMA).

14 Jul 2015

Ferrer begins Lorediplon phase IIa trial in patients with insomnia disorder

Ferrer, a privately-held Spanish pharmaceutical company, today announces the first patient has been recruited into a phase IIa clinical trial to test the efficacy, safety and tolerability profile of Lorediplon in adult patients with insomnia disorder. The study is scheduled to be completed by Q4, 2016.

14 Jul 2015

FDA accepts Blueprint Medicines' IND applications to start Phase 1 clinical trials for two drug candidates

Blueprint Medicines today announced that the U.S. Food and Drug Administration accepted the Company's Investigational New Drug (IND) applications to begin Phase 1 clinical trials for its two lead drug candidates: BLU-554 for the treatment of advanced hepatocellular carcinoma (HCC) and cholangiocarcinoma, and BLU-285 for unresectable, treatment-resistant gastrointestinal stromal tumor (GIST).

13 Jul 2015

OncoGenex's custirsen Phase 3 ENSPIRIT trial for treatment of NSCLC patients continues as planned

OncoGenex Pharmaceuticals, Inc. announced today that its Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). This decision was based upon completion of the second and final planned interim futility analysis.

13 Jul 2015

Too much transparency in clinical trials data may inhibit drug development, says researchers

New legislation forces drug developers to disclose most of their clinical trials data when applying for approval of a new drug. Many will probably think that this is a good idea. However, too much transparency in drug development might be problematic, according to Timo Minssen, researcher at the University of Copenhagen.

13 Jul 2015

Anika Therapeutics announces positive results from CINGAL phase 3 trial for knee osteoarthritis

Anika Therapeutics, Inc.,, a leader in products for tissue protection, healing, and repair based on hyaluronic acid technology, today reported positive results from the CINGAL 13-02 study evaluating the safety of a repeat injection of Cingal for symptomatic relief of osteoarthritis of the knee.

10 Jul 2015

Janssen-sponsored Phase 2b trial shows guselkumab effective in treating moderate to severe plaque psoriasis

Results published today in The New England Journal of Medicine from a Janssen Research & Development, LLC (Janssen)-sponsored Phase 2b trial showed up to 86 percent of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician's Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study's primary endpoint.

9 Jul 2015

Phase 3 ODYSSEY JAPAN trial of Praluent injection meets primary endpoint

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent® (alirocumab) Injection met its primary endpoint.

9 Jul 2015

Guselkumab drug more effective than current standard of care for psoriasis

A phase II clinical trial led by Northwestern Medicine investigators shows that a new psoriasis drug called guselkumab has greater efficacy than the current standard of care for the chronic skin condition.

9 Jul 2015

Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

Ludwig Cancer Research and the Cancer Research Institute have launched clinical trials evaluating an immunotherapy for the treatment of the brain cancer glioblastoma multiforme (GBM), and a combination of immunotherapies for a variety of solid tumors.

8 Jul 2015

Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for AR-301, also referred to as Salvecin, the company's fully human anti-Staphylococcal α-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant 'MRSA' strains.

8 Jul 2015

DSMB recommends continuation of Genticel’s GTL001 phase 2 trial in HPV-infected women

Genticel, a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus, today announces that the independent Data Safety Monitoring Board recommends the continuation, per protocol, of its phase 2 clinical trial of GTL001 in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases.

8 Jul 2015

Cognizin citicoline shows promise in patients with bipolar disorder and cocaine dependence

The results of a randomized, double-blind, placebo-controlled clinical trial showed that Cognizin citicoline (Jarrow Formulas) was effective at reducing cocaine use, based on urine drug screens, in patients with bipolar disorder and cocaine dependence. The study, published in the American Journal of Psychiatry in Advance, included a total of 130 outpatients with bipolar I disorder and cocaine dependence, who received either Cognizin citicoline or placebo add-on therapy for 12 weeks.

7 Jul 2015

Abide Therapeutics begins Phase 1a study of ABX-1431 investigational endocannabinoid system modulator

Abide Therapeutics, a developer of innovative pharmaceuticals, announced today initiation of enrollment and dosing of the first subject in a Phase 1a clinical study of ABX-1431, a first-in-class, investigational endocannabinoid system modulator.

7 Jul 2015

NIH-sponsored clinical trial evaluates new investigational vaccine against West Nile Virus infection

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

7 Jul 2015

Pazopanib improves survival in soft tissue sarcoma patients without impairment of health-related quality of life

Results of EORTC trial 62072 appearing in Cancer show that in patients with soft tissue sarcoma, whose disease had progressed during or after prior chemotherapy, pazopanib improved progression-free survival but did not change health-related quality of life. This observed improvement in progression-free survival without impairment of health-related quality of life was considered a meaningful result.

7 Jul 2015

Celtaxsys receives FDA clearance to begin acebilustat Phase 2 trial in adult CF patients in the US

Celtaxsys, Inc., a clinical stage pharmaceutical development company focusing on anti-inflammatory therapeutics, including those with rare and orphan inflammatory disease indications, announced today that it has gained clearance from the U.S. Food and Drug Administration to begin a Phase 2 clinical trial of its flagship drug candidate, acebilustat (CTX-4430), in adult CF patients in the US.

7 Jul 2015

Boehringer Ingelheim LUX-Lung 8 trial reveals afatinib better than erlotinib to treat SCC of the lung

Boehringer Ingelheim today announced The Lancet Oncology has published results from the LUX-Lung 8 trial. LUX-Lung 8 is the largest, prospective Phase III head-to-head trial directly comparing two EGFR-directed treatments.

6 Jul 2015

ImmunoCellular, Novella partner to conduct ICT-107 phase 3 registration trial in patients with glioblastoma

ImmunoCellular Therapeutics, Ltd. today announced the establishment of an agreement with Novella Clinical (Novella), to conduct the phase 3 registration trial of ICT-107 in patients with newly diagnosed glioblastoma. Novella is a full-service, global clinical research organization (CRO) providing clinical trial services to small to mid-sized oncology companies.

6 Jul 2015

Drug Trial News

Most patients with depression excluded from antidepressant trials, study finds

Isis Pharmaceuticals receives $2.15 million milestone payment to advance ISIS-SMN Rx study in children with SMA

Ferrer begins Lorediplon phase IIa trial in patients with insomnia disorder

FDA accepts Blueprint Medicines' IND applications to start Phase 1 clinical trials for two drug candidates

OncoGenex's custirsen Phase 3 ENSPIRIT trial for treatment of NSCLC patients continues as planned

Too much transparency in clinical trials data may inhibit drug development, says researchers

Anika Therapeutics announces positive results from CINGAL phase 3 trial for knee osteoarthritis

Janssen-sponsored Phase 2b trial shows guselkumab effective in treating moderate to severe plaque psoriasis

Phase 3 ODYSSEY JAPAN trial of Praluent injection meets primary endpoint

Guselkumab drug more effective than current standard of care for psoriasis

Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

DSMB recommends continuation of Genticel’s GTL001 phase 2 trial in HPV-infected women

Cognizin citicoline shows promise in patients with bipolar disorder and cocaine dependence

Abide Therapeutics begins Phase 1a study of ABX-1431 investigational endocannabinoid system modulator

NIH-sponsored clinical trial evaluates new investigational vaccine against West Nile Virus infection

Pazopanib improves survival in soft tissue sarcoma patients without impairment of health-related quality of life

Celtaxsys receives FDA clearance to begin acebilustat Phase 2 trial in adult CF patients in the US

Boehringer Ingelheim LUX-Lung 8 trial reveals afatinib better than erlotinib to treat SCC of the lung

ImmunoCellular, Novella partner to conduct ICT-107 phase 3 registration trial in patients with glioblastoma

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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