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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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.
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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
Business Wire Health: Clinical Trials News
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.
Business Wire Health: Clinical Trials News
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)
Business Wire Health: Clinical Trials News
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
Click image to enlarge
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

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