• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Cold Chain Packaging and Logistics

    How Artificial Intelligence and Machine Learning are Transforming the Life Sciences

    Challenges of Preparing Highly Potent Oral Products

    Bioprocessing Trends

    Sustainable Manufacturing
    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
    Pasithea Signs CMC Development and Manufacturing Agreement

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    groninger Continues Growth in the US

    Catalent Bolsters Cell and Gene Services
    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

    What Does the Future of API Synthesis Look Like?

    Pasithea Signs CMC Development and Manufacturing Agreement

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    Jaguar Health Achieves Key Milestone for Crofelemer API Manufacturer
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Bolsters Cell and Gene Services

    CDMO Sirio Pharma Completes the Acquisition of Best Formulations

    Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

    Case Study: Secondary Sourcing Strategies to Ensure Supply Chain Security

    Beat the Supply Chain Backlog
    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

    Experic Expands Analytical Capabilities and Facilities

    List Labs Expands Manufacturing Capacity

    Catalent Bolsters Cell and Gene Services

    Crown Bioscience to Acquire Indivumed’s Service Biz and Supporting Biobank

    Stevanato Group, Transcoject Partner on Pre-Fillable Syringe Polymer Options
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Adare Partners with Veeva to Strengthen Quality Operations

    KBI Secures Swissmedic Regulatory Establishment License for Facility in Geneva

    Enhancing Ease of Use, Batch Turnaround, and Process Flexibility

    Understanding the Essential Role of a Qualified Person

    Altasciences Los Angeles Clinical Site Receives CAP Accreditation
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    CMC Pharmaceuticals

    INCOG BioPharma Services

    Syngene International Ltd.

    Alcami

    LOTTE BIOLOGICS
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    CMC Pharmaceuticals

    INCOG BioPharma Services

    Syngene International Ltd.

    Alcami

    LOTTE BIOLOGICS
    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
    • White Papers
    • Podcasts
    • Infographics
    • Microsites
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • 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

    Aetion Launches Research Collaboration with FDA

    Aims to advance understanding of COVID-19.

    Related CONTENT
    • Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients
    • J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax
    • Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention
    • BioVaxys Reports Progress on Covid-19 Vax Candidate
    • Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals
    Contract Pharma Staff05.20.20
    Aetion has signed a research collaboration agreement with the U.S. Food and Drug Administration (FDA) to use real-world data to advance the understanding of and response to coronavirus disease (COVID-19).
     
    The research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns, by facilitating the use of relevant, novel data sources and analyzing these data according to well-established principles.
     
    "The FDA is approaching the generation of real-world evidence for COVID-19 with a sense of urgency to learn what we can, as soon as we can, from patients who are receiving care right now," said Amy Abernethy, M.D., Ph.D., principal deputy commissioner of food and drugs at FDA. "We also recognize that COVID-19 is a dynamic situation. We can use current data and learn what decisions we can confidently make now, and we can learn what we'll need to do in the future as more data become available."
     
    Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications, and contribute to the scientific evaluation of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which includes structured workflows and transparent reporting to facilitate efficient sharing, examination, and reproduction of findings.
     
    "As regulators and industry mobilize to address COVID-19, it's critical that we learn from the data generated by the health care system," said Carolyn Magill, CEO of Aetion. "This collaboration will employ Aetion's analytic platform and a variety of real-world data sources to rapidly, reliably, and transparently produce actionable insights to serve patients and address the daily challenges they face." 
    Related Searches
    • bioavailability
    • real-world data
    • granules
    • facility
    Suggested For You
    Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients  Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients
    J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax
    Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention
    BioVaxys Reports Progress on Covid-19 Vax Candidate BioVaxys Reports Progress on Covid-19 Vax Candidate
    Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals
    U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail
    U.S. Govt. Purchases Additional Doses of Lilly U.S. Govt. Purchases Additional Doses of Lilly's Antibody Therapies for COVID
    Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies
    Boyds Opens US Office in PA Boyds Opens US Office in PA
    COVID Booster Vaccines: What’s Next for FDA COVID Booster Vaccines: What’s Next for FDA
    Repligen and Navigo Launch Antibody Technology Platform Repligen and Navigo Launch Antibody Technology Platform
    Trust, but Verify Trust, but Verify
    API Development Trends API Development Trends
    Outsourcing the Manufacture of Clinical Trial APIs Outsourcing the Manufacture of Clinical Trial APIs
    Inhaled Drug Delivery Trends Inhaled Drug Delivery Trends

    Related Breaking News

    • Breaking News | Drug Development | Industry News
      Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients

      Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients

      Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization.
      09.22.21

    • Biologics, Proteins, Vaccines | Breaking News | Industry News
      J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax

      J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax

      Phase 3 ENSEMBLE trial shows booster shot at two months provided 94 percent protection against COVID-19 in the U.S.
      09.21.21

    • Breaking News | Industry News
      Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention

      Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention

      Phase 3 study shows bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents.
      09.17.21


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News | Parenterals
      BioVaxys Reports Progress on Covid-19 Vax Candidate

      BioVaxys Reports Progress on Covid-19 Vax Candidate

      Bioproduction partner Wuxi Biologics completes synthesis of recombinant SARS-CoV-2 s-proteins for BVX-0320 and CoviDTH programs.
      09.16.21

    • Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments
      Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals

      Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals

      Will make lead compound vonoprazan from Winchester, KY facility if approved by FDA.
      09.16.21

    Loading, Please Wait..
    Trending
    • Sarepta And Catalent Expand Manufacturing Partnership
    • Forge Biologics Strengthens Genetic Medicine CDMO Capabilities
    • Colorcon Signs Agreement To Purchase Airnov Healthcare Packaging
    • The Ongoing Evolution And Implementation Of DCTs In 2023
    • EyePoint Pharmaceuticals To Build GMP Mfg. Facility In Northbridge, MA
    Breaking News
    • Pasithea Signs CMC Development and Manufacturing Agreement
    • Experic Expands Analytical Capabilities and Facilities
    • List Labs Expands Manufacturing Capacity
    • groninger Continues Growth in the US
    • Catalent Bolsters Cell and Gene Services
    View Breaking News >
    CURRENT ISSUE

    November/December 2022

    • Cold Chain Packaging and Logistics
    • Optimizing Supply Chains for Allogeneic Cell Therapy Trials
    • Sustainable Manufacturing
    • Bioprocessing Trends
    • How Artificial Intelligence and Machine Learning are Transforming the Life Sciences
    • 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

    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients
    Vitamin D Supplementation Reduces Risk of Dynapenia
    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    BMP Medical Expands Sterling, Massachusetts Facility
    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pasithea Signs CMC Development and Manufacturing Agreement
    Experic Expands Analytical Capabilities and Facilities
    List Labs Expands Manufacturing Capacity
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Walgreens Boots Alliance Shares 2022 ESG Report
    Happi

    Latest Breaking News From Happi

    KimChi Beauty Launches Spinning Hearts Love 02 Ahead of Valentine’s Day
    Dark & Lovely Names Actress Meagan Good Brand Ambassador
    Natural Household Care Company Tru Earth Adds Dishwasher Detergent Tablets
    Ink World

    Latest Breaking News From Ink World

    Xerox Releases 4Q, Full-Year 2022 Results
    Electronics For Imaging Names Frank Pennisi as CEO
    Fiery to Separate from EFI, Remain Wholly-Owned by Siris
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Bobst boosts senior sales team with Keith Nagle
    Penmar Industries adds Screen Truepress Jet L350UV SAI digital press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Launches the Mariner Deformity System
    Tyber Medical Hires 2 New Execs
    Miach Ortho Raises $40M in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Smart Devices with Privacy Focus Have More Consumer Appeal
    Siman Group Partners with SML to Unlock Full Retail Potential with RFID
    Brewer Science Presents Optics Integration Solutions at SPIE Photonics West

    Copyright © 2023 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