Κυριακή, 31 Μαρτίου 2019

Clinical Trials

European Medicines Agency Accepts Takeda's Marketing Authorization Application for a Subcutaneous Formulation of Vedolizumab for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
OSAKA, Japan--(BUSINESS WIRE)--EMA has accepted a marketing authorization application for a subcutaneous formulation of vedolizumab for maintenance therapy in UC and CD
Business Wire Health: Clinical Trials News
08:00
CELGENE ERHÄLT ZULASSUNGSEMPFEHLUNGEN DES CHMP FÜR AUF LENALIDOMID (REVLIMID®) UND POMALIDOMID (IMNOVID®) BASIERENDEN TRIPLETT-KOMBINATIONSTHERAPIEN ZUR BEHANDLUNG VON PATIENTEN MIT MULTIPLEM MYELOM
SUMMIT, N.J.--(BUSINESS WIRE)--Wie die Celgene Corporation (NASDAQ:CELG) heute bekannt gab, hat der Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittelagentur (EMA) positive Stellungnahmen zu zwei Triplett-Regimen veröffentlicht, die auf den von Celgene entwickelten und vermarkteten IMiD®-Wirkstoffen Lenalidomid (REVLIMID®) und Pomalidomid (IMNOVID®) basieren. Das CHMP empfiehlt die Zulassung einer Indikationserweiterung von Lenalidomid zur Kombinationstherapie mit Bortezomib u
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02:59
Forbius' AVID100, a Novel Anti-EGFR ADC, Reports Positive Phase 1 Data at AACR: Exceptionally High RP2D Established, Phase 2 in SCCHN and sqNSCLC Ongoing
AUSTIN, Texas & MONTREAL--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/AACR?src=hash" target="_blank"gt;#AACRlt;/agt;--Forbius' AVID100 Reports Positive Phase 1 Data at AACR: Exceptionally High RP2D Established, Phase 2 in SCCHN and sqNSCLC Ongoing
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Fri Mar 29, 2019 21:44
Celularity Announces Results of Phase 1 Studies of PNK-007, an Allogeneic, Off-the-Shelf, Placental-Derived Cell Therapy, at AACR Annual Meeting 2019
WARREN, N.J.--(BUSINESS WIRE)--Celularity, Inc. ("Celularity" or the "Company"), a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, today announced results from two Phase 1 studies of PNK-007, an investigational allogeneic off-the-shelf natural killer (NK) cell therapy, in patients with acute myeloid leukemia (AML) and in patients with multiple myeloma (MM). Translational immunotherapy study results from the Company's late-breakin
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Fri Mar 29, 2019 21:15
Northern Biologics Reports Initial Phase I Data for MSC-1 at AACR
TORONTO--(BUSINESS WIRE)--Northern Biologics Inc., a company focused on developing first-in-class immuno-oncology products, today announced the presentation of initial results from the Phase I trial of their lead antibody, MSC-1, at the American Association for Cancer Research meeting in Atlanta, Georgia. Session Title: Phase I Clinical Trials: Part 1Session Date and Time: Sunday Mar 31, 2019 1:00 PM - 5:00 PMSession Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16 Pos
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Fri Mar 29, 2019 21:01
Arch Oncology to Present Preclinical Data on Highly-Differentiated Anti-CD47 Antibody AO-176 at the AACR Annual Meeting 2019
BRISBANE, Calif. & ST. LOUIS--(BUSINESS WIRE)--Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 therapies for cancer, today announced the presentation of two posters at the American Association for Cancer Research (AACR) Annual Meeting to be held March 29 – April 3, 2019 in Atlanta, GA. "We are excited to present these new sets of preclinical data at AACR, highlighting the progress our team is making with advancing
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Fri Mar 29, 2019 21:00
Preliminary Data from Phase 1 Study Evaluating ADXS-NEO Suggest Rapid Immunogenicity and Clinical Activity
PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces the presentation of ADXS-NEO data in a poster discussion entitled "Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients" at the American Association for Cancer Research (AACR) Annual Meeting underway in Atlanta. The discussion will be held on Sunday, March 31, 2019
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Fri Mar 29, 2019 21:00
CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI reports recent data review by the Independent Data Monitoring Committee for its pivotal Phase 3 head and neck cancer study.
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Fri Mar 29, 2019 15:00
Celgene Receives CHMP Positive Opinions for Both REVLIMID® (lenalidomide) and IMNOVID® (pomalidomide)-Based Triplet Combination Regimens for Patients with Multiple Myeloma
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene's proprietary IMiD® medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide). The CHMP recommended approval of an expanded indication of REVLIMID as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patie
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Fri Mar 29, 2019 14:12
Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) today announced completion of enrollment in the potentially pivotal innovaTV 204 phase 2 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Tisotumab vedotin is being developed in collaboration with Genmab A/S. The innovaTV 204 trial is intended to sup
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Fri Mar 29, 2019 14:00
Boehringer Ingelheim Enhances Oncology R&D with Novel MacroDel Delivery Technology Via Acquisition of ICD Therapeutics
INGELHEIM, Germany & BERLIN--(BUSINESS WIRE)--Boehringer Ingelheim today announced that it acquired ICD Therapeutics. The acquisition includes rights to ICD's innovative MacroDel biologics-delivery platform. Boehringer Ingelheim will employ this platform for the development of novel therapeutics in collaboration with nanoPET Pharma GmbH, a former shareholder of ICD Therapeutics. Further details of the acquisition are not being disclosed. "Boehringer Ingelheim's collaboration with nanoPET Pharma
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Fri Mar 29, 2019 14:00
Bicycle Therapeutics to Present Preclinical Data on EphA2 and Nectin-4 Bicycle Toxin Conjugate Programs, as well as a CD137 Immune Oncology Program, at the American Association for Cancer Research Annual Meeting
CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics will present data on preclinical programs at the American Association for Cancer Research Annual Meeting.
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Fri Mar 29, 2019 14:00
bluebird bio Receives Positive Opinion from CHMP for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia (TDT) Who Do Not Have β0/β0 Genotype
CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq:BLUE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization for ZYNTEGLO™ (autologous CD34+ cells encoding β A-T87Q-globin gene), a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC)
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Fri Mar 29, 2019 13:44
Antibe Therapeutics Announces Commencement of Phase 2B Dose-Ranging, Efficacy Study for Lead Drug, ATB-346
TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Announces Commencement of Phase 2B Dose-Ranging, Efficacy Study for Lead Drug, ATB-346
Business Wire Health: Clinical Trials News
Fri Mar 29, 2019 13:00
Dicerna™ Announces the Presentation of Updated Data Demonstrating Utility of its Lead Compound DCR-PHXC in Treating Primary Hyperoxaluria Type 1 (PH1) and Type 2 (PH2)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dicerna announces the presentation of updated data from its ongoing PHYOX™1 Phase 1 clinical trial evaluating DCR-PHXC.
Business Wire Health: Clinical Trials News
Fri Mar 29, 2019 12:30
Asthma - Maitland FL
Are you or a loved one living with Asthma? Meridien Research is currently seeking adolescent and adult volunteers to participate in a research study. To take part, you must be: Over the age of 12 years old Experiencing persistent asthma for at least 12 weeks Be a current non-smoker and have not used tobacco products within the past year All study-related care will be provided at no cost. Learn more about our Asthma study and see if you may qualify!
ClinicalConnection.com New Clinical Trials
Fri Mar 29, 2019 18:21
Weight Loss - Tustin CA
Commit to at least 17-25 office visits for 8 months. May require to drive to a second location as part of the program. 
ClinicalConnection.com New Clinical Trials
Thu Mar 28, 2019 00:00
Depression - Miami FL
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ClinicalConnection.com New Clinical Trials
Thu Mar 28, 2019 00:00
AstraZeneca, Daiichi Sankyo enter into $6.9bn cancer deal
As part of the global development and commercialization collaboration, AstraZeneca and Daiichi Sankyo will develop and commercialize trastuzumab deruxtecan (DS-8201), which is an antibody-drug conjugate (ADC) and potential The post AstraZeneca, Daiichi Sankyo enter into $6.9bn cancer deal appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Fri Mar 29, 2019 12:51
FDA approves treatment for patients with non-radiographic axial spondyloarthritis
This is the first time that the FDA has approved a treatment for nr-axSpA. "Today's approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial The post FDA approves treatment for patients with non-radiographic axial spondyloarthritis appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Fri Mar 29, 2019 10:55
Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Fri Mar 29, 2019 09:08
Globalization of clinical trials: Variation in estimated regional costs of pivotal trials, 2015–2016
Clinical Trials, Ahead of Print.
SAGE Publications: Clinical Trials: Table of Contents
Fri Mar 29, 2019 09:05
Design and sample size considerations for Alzheimer's disease prevention trials using multistate models
Clinical Trials, Volume 16, Issue 2, Page 111-119, April 2019.
SAGE Publications: Clinical Trials: Table of Contents
Fri Mar 29, 2019 08:14