• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Global Biosciences Co. Selects ValGenesis VLMS

    Eisai Appoints Chief Clinical Officer of Oncology Biz

    Nexelis Acquires GSK Vax Lab in Marburg

    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

    NovaQuest Private Equity Acquires CoreRx
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules

    Cognate BioServices Announces Major Expansion

    Sanofi Unveils EUROAPI as Name of New European API Company

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

    Thermo Fisher Expands Clinical Supply Services in Europe

    Schreiner MediPharm Joins DoseID Consortium
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Global Biosciences Co. Selects ValGenesis VLMS

    Nexelis Acquires GSK Vax Lab in Marburg

    The Future of Clinical Trials Series: Part I

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    CDMO Cognate BioServices Teams Up with L7 Informatics

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Baxter BioPharma Solutions

    Cytovance Biologics

    Flow Sciences

    Alcami
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Flow Sciences

    Reed-Lane

    Adare Pharma Solutions

    Alcami

    Syngene
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    J&J Initiates Phase III ENSEMBLE Trial for COVID-19 Vax

    Will enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose of JNJ-78436735 versus placebo.

    Related CONTENT
    • Frontida BioPharm Appoints Chief Financial Officer
    • Trial Runners
    • Financial Report: Johnson & Johnson
    • Novavax, Par Sterile Products Enter COVID-19 Vax Mfg. Pact
    • GRAM, J&J Enter COVID-19 Vax Manufacturing Pact
    Contract Pharma Staff09.23.20

    Johnson & Johnson has initiated its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Phase I/IIa clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. Based on these results and following discussions with the U.S. FDA, ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

    Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.

    The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.

    The Janssen COVID-19 vaccine candidate leverages the company's AdVac technology platform, which was also used to develop and manufacture Janssen's European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. Janssen's investigational vaccine programs.

    With Janssen's AdVac technology, the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C. This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.

    Related Searches
    • Clinical Trials
    • Biologics, Proteins, Vaccines
    Suggested For You
    Frontida BioPharm Appoints Chief Financial Officer Frontida BioPharm Appoints Chief Financial Officer
    Trial Runners Trial Runners
    Financial Report: Johnson & Johnson Financial Report: Johnson & Johnson
    Novavax, Par Sterile Products Enter COVID-19 Vax Mfg. Pact Novavax, Par Sterile Products Enter COVID-19 Vax Mfg. Pact
    GRAM, J&J Enter COVID-19 Vax Manufacturing Pact GRAM, J&J Enter COVID-19 Vax Manufacturing Pact
    Hovione to Support Manufacture of Remdesivir for COVID-19 Hovione to Support Manufacture of Remdesivir for COVID-19
    ARCA Submits IND for AB201 in COVID-19 ARCA Submits IND for AB201 in COVID-19
    BioNTech to Acquire Novartis Mfg. Site for COVID-19 Vax Production BioNTech to Acquire Novartis Mfg. Site for COVID-19 Vax Production
    Pharma Supply Chain Logistics & Potential COVID-19 Vaccines Pharma Supply Chain Logistics & Potential COVID-19 Vaccines
    Lilly, Amgen Enter Antibody Mfg. Pact for COVID-19 Therapies Lilly, Amgen Enter Antibody Mfg. Pact for COVID-19 Therapies
    FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine
    Valneva Partners with UK Government for COVID-19 Vaccine Valneva Partners with UK Government for COVID-19 Vaccine
    Valneva, Dynavax Enter COVID-19 Vax Supply Pact  Valneva, Dynavax Enter COVID-19 Vax Supply Pact
    Novavax, Serum Institute of India Enter COVID-19 Vax Mfg. Pact Novavax, Serum Institute of India Enter COVID-19 Vax Mfg. Pact
    BioNTech to Receive German Federal Ministry Funding for COVID-19 Vax BioNTech to Receive German Federal Ministry Funding for COVID-19 Vax

    Related Breaking News

    • Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News
      Nexelis Acquires GSK Vax Lab in Marburg

      Nexelis Acquires GSK Vax Lab in Marburg

      Enters into a 5-year strategic agreement to support the development of future GSK vaccine candidates.
      Contract Pharma Staff 01.20.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
      JS Bio and Etta Biotech Advancing Partnership

      JS Bio and Etta Biotech Advancing Partnership

      Will set up a high titer transient protein expression platform for high quality protein production.
      Contract Pharma Staff 01.19.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
      Intravacc Completes Project for Provention Bio’s Vax Candidate

      Intravacc Completes Project for Provention Bio’s Vax Candidate

      Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.
      Contract Pharma Staff 01.19.21


    • Breaking News | Clinical Trials | Industry News
      Grifols Begins COVID-19 Plasma Treatment Trial

      Grifols Begins COVID-19 Plasma Treatment Trial

      Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.
      Contract Pharma Staff 01.18.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Cognate BioServices Announces Major Expansion

      Cognate BioServices Announces Major Expansion

      Will increase cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities and more.
      Contract Pharma Staff 01.15.21

    • Breaking News | Clinical Trials | CRO News | Industry News
      Frontage Bolsters Clinical Services Capabilities

      Frontage Bolsters Clinical Services Capabilities

      Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.
      Contract Pharma Staff 01.15.21


    • Biologics, Proteins, Vaccines | Breaking News | Industry News
      Thermo Fisher Buys Novasep

      Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

      Pays more than $800 million to expand global capacity and address growing demand for cell and gene therapy.
      Contract Pharma Staff 01.15.21

    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Precision Medicine Group Acquires Project Farma

      Precision Medicine Group Acquires Project Farma

      Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
      Contract Pharma Staff 01.14.21

    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Cytiva Delivers Modular Biologics Factory to Lonza

      Cytiva Delivers Modular Biologics Factory to Lonza

      Site to become a strategic base in China for Lonza to provide CDMO services throughout Asia Pacific region.
      Contract Pharma Staff 01.14.21


    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

      Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

      FUJIFILM Diosynth Biotechnologies will provide GMP contract process development and manufacturing services as part of its role in the new center.
      Contract Pharma Staff 01.14.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
      RheinCell Therapeutics Achieves GMP Certification

      RheinCell Therapeutics Achieves GMP Certification

      Marks a milestone for the evolution of the company.
      Contract Pharma Staff 01.13.21

    • Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News | Process Development
      Capricor, Lonza Enter CAP-1002 Development Agreement

      Capricor, Lonza Enter CAP-1002 Development Agreement

      Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.
      Contract Pharma Staff 01.12.21


    • Biologics, Proteins, Vaccines | Breaking News | Drug Delivery | Industry News
      iosBio Inks Exclusive Vax Platform Pact for COVID-19

      iosBio Inks Exclusive Vax Platform Pact for COVID-19

      OraPro oral delivery vaccine platform technology enables oral administration of thermally-stable, viral vector vaccines.
      Contract Pharma Staff 01.12.21

    • Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
      Adagene Achieves CAR-T Collaboration Milestone

      Adagene Achieves CAR-T Collaboration Milestone

      Yields potential first-ever antibodies targeting human endogenous retrovirus associated with kidney cancer.
      Contract Pharma Staff 01.12.21

    • Breaking News | Clinical Trials | CRO News
      Parexel Completes Strategic Separation

      Parexel Completes Strategic Separation

      Aims to simplify and streamline business strategy and customer relationships while positioning both organizations for long-term growth.
      Contract Pharma Staff 01.12.21

    Trending
    • Lonza To Exit Pharma Softgels And Liquid-Filled Hard Capsules
    • Roche Canada To Invest $500M To Create 500 Jobs In Ontario
    • Grifols Begins COVID-19 Plasma Treatment Trial
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Virtual Clinical Trials: The Future Of Dermatology Studies
    Breaking News
    • Global Biosciences Co. Selects ValGenesis VLMS
    • Eisai Appoints Chief Clinical Officer of Oncology Biz
    • Nexelis Acquires GSK Vax Lab in Marburg
    • Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    • NovaQuest Private Equity Acquires CoreRx
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Ingredient Manufacturers Discuss the E-Sports Market
    Euromonitor Names Top Ten Trends for 2021
    Study Highlights Differences Between EPA's and DHA's Effect on Sleep
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial
    RSIP Vision Announces Versatile Medical Image Segmentation Tool
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Global Biosciences Co. Selects ValGenesis VLMS
    Eisai Appoints Chief Clinical Officer of Oncology Biz
    Nexelis Acquires GSK Vax Lab in Marburg
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top Beauty Brands in the World—And Most Loved Fragrances
    P&G Reports Q2 Results
    A Lacquering Technique Makes Very Good Girl by Carolina Herrera Shine
    Happi

    Latest Breaking News From Happi

    Flow Launches Collagen Waters
    David Stanko Joins JPMS
    Ross Introduces Double Cone Tumble Blender
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Domino grows installation and service teams
    ABG keeps pace with demand with recruitment drive
    Acucote expands FSC-certified portfolio
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    First Quality Launches Incognito by Prevail
    Essity Launches Reusable Underwear Product
    Honeywell Delivered 225 Million Masks in December
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    DJO Acquires Trilliant Surgical
    FDA Breakthrough Device Designation Granted to Spiderwort's Spinal Cord Technology
    Bioventus Appoints SVP of Operations
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login