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Phase III studies show Roche's ocrelizumab reduces relapse rate, delays disability progression in MS patients

Three phase III studies being presented at the European Committee for Treatment Research in Multiple Sclerosis congress demonstrate that treating MS with ocrelizumab reduces relapse rate and delay onset of disability progression compared to interferon beta-1a in relapsing forms of MS and disability progression in primary progressive MS compared to placebo.

12 Oct 2015

Safety and immunogenicity clinical trial of Ebola vaccine regimen starts in Sierra Leone

Johnson & Johnson today announced the start of a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies.

9 Oct 2015

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF).

8 Oct 2015

EMA completes review of proposed amendment to OncoGenex's Phase 3 AFFINITY trial protocol

OncoGenex Pharmaceuticals, Inc. announced today that the European Medicines Agency has completed its review of the proposed amendment to the company's Phase 3 AFFINITY protocol and statistical analysis plan.

8 Oct 2015

SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

SynAgile Corporation, a privately held pharmaceutical company that develops and commercializes drug delivery systems using its proprietary OraFuse intraoral technology platform, today announced positive results from a proof-of-concept, Phase 2a, open-label clinical trial of continuous intraoral administration of levodopa-carbidopa (LD/CD).

8 Oct 2015

Phase II psoriasis study shows efficacy of Boehringer Ingelheim's BI 655066 over ustekinumab

New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim's investigational biologic compound BI 655066, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab.

8 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

8 Oct 2015

Smoking cessation medication 46% effective in women

The most effective prescription drug used to quit smoking initially helps women more than men, according to a Yale School of Medicine study. The study, published Oct. 7 by the journal Nicotine and Tobacco Research, found that varenicline, marketed as Chantix, was more effective earlier in women, and equally effective in women and men after one year.

8 Oct 2015

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study.

7 Oct 2015

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Biogen (NASDAQ: BIIB) will, this week, present data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, demonstrating the efficacy and safety of TECFIDERA® (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS).

7 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute and breakthrough pain, today announced the initiation of an open-label Phase 3 study (SAP302) of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury.

6 Oct 2015

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company's lead product candidate, ENV515 (travoprost XR).

6 Oct 2015

Oncolytics completes Phase II trial enrollment for REOLYSIN in prostate cancer

Oncolytics Biotech Inc. today announced that enrollment has been completed in a randomized Phase II study of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer (IND 209). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario.

6 Oct 2015

Vaccination against type 1 diabetes may soon be available to young children

A vaccination against type 1 diabetes will soon also be available to young children: the Pre-POINTearly vaccination study will involve children between the ages of six months and two years from across Germany who have a first-degree relative with type 1 diabetes.

6 Oct 2015

Clinical data from spinal muscular atrophy program presented at 20th International WMS Congress

PTC Therapeutics, Inc., today announced that clinical data from the company's joint development program with Roche and the SMA Foundation in spinal muscular atrophy (SMA) were presented at the 20th International Congress of the World Muscle Society (WMS) in Brighton, U.K.

5 Oct 2015

OncoGenex meets target enrollment in apatorsen Phase 2 trial

OncoGenex Pharmaceuticals, Inc. announced today that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.

30 Sep 2015

BiondVax to begin Phase IIb clinical trial of universal influenza vaccine in Europe

BiondVax Pharmaceuticals Ltd. announced today that it received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase IIb clinical trial. The initiation meeting was scheduled for today, September 30, 2015, together with the partners from the UNISEC European Consortium.

30 Sep 2015

Phase II IMvigor 210 data shows atezolizumab may prevent progression of metastatic urothelial bladder cancer

Data presented today at the 2015 European Cancer Congress (ECC) demonstrates that the investigational immunotherapy atezolizumab may prevent progression of metastatic urothelial bladder cancer (mUBC) in all age groups by 2.1 months.

29 Sep 2015

Drug Trial News

Phase III studies show Roche's ocrelizumab reduces relapse rate, delays disability progression in MS patients

Safety and immunogenicity clinical trial of Ebola vaccine regimen starts in Sierra Leone

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

EMA completes review of proposed amendment to OncoGenex's Phase 3 AFFINITY trial protocol

SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

Phase II psoriasis study shows efficacy of Boehringer Ingelheim's BI 655066 over ustekinumab

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Smoking cessation medication 46% effective in women

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

First patients screened in Axovant's phase 3 study of RVT-101

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Oncolytics completes Phase II trial enrollment for REOLYSIN in prostate cancer

Vaccination against type 1 diabetes may soon be available to young children

Clinical data from spinal muscular atrophy program presented at 20th International WMS Congress

OncoGenex meets target enrollment in apatorsen Phase 2 trial

BiondVax to begin Phase IIb clinical trial of universal influenza vaccine in Europe

Phase II IMvigor 210 data shows atezolizumab may prevent progression of metastatic urothelial bladder cancer

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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