• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Solution Center
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Solution Center
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    CDMOs in the Spotlight: Investing in Themselves

    Extrusion-Spheronization in OSD Manufacturing

    Modernizing Therapeutic Cell Production

    Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold

    Digital Transformation in Pharma
    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
    ValiRx Signs Lease Deal with Nottingham Laboratories

    Civica Partners with Ypsomed for Insulin Injection Pen

    Charles River Laboratories Completes the Acquisition of SAMDI Tech

    Selkirk Pharma Names New Director for Business Development

    Center for Breakthrough Medicines Introduces Precision Plasmids 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

    Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing

    Upsher-Smith Opens State-of-the-Art Manufacturing Facility

    Elektrofi, Thermo Fisher Enter Strategic Contract Manufacturing Pact

    Societal CDMO Signs More Than $6M in Work Orders During 4Q22

    Genenta Science, AGC Biologics Enter Development and Manufacturing Service Pact
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Upsher-Smith Opens State-of-the-Art Manufacturing Facility

    Beat the Supply Chain Backlog

    HPNE Launches Innovative Single-Use Assembly Service

    CDMO Selection and Tech Transfer – An Insider’s Guide to Injectables Excellence

    Catalent Bolsters Cell and Gene Services
    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

    ValiRx Signs Lease Deal with Nottingham Laboratories

    Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing

    Genenta Science, AGC Biologics Enter Development and Manufacturing Service Pact

    Baby Steps Toward the 21st Century

    Modernizing Therapeutic Cell Production
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold

    People and Culture Drive Operational Excellence

    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
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Quotient Sciences

    Lannett CDMO

    Societal CDMO

    Almac Group

    Syngene International Ltd.
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Quotient Sciences

    Lannett CDMO

    Societal CDMO

    Almac Group

    Syngene International Ltd.
    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

    Mylan, Theravance Biopharma Partner to Submit NDA

    The drug is in development for the treatment of chronic obstructive pulmonary disease

    Related Content
    • Inhaled Drug Delivery Trends
    • Boehringer-Ingelheim
    • Generic Version of Symbicort Granted FDA Approval
    • Aerosol Delivery Devices Market
    • Inhaled Drug Delivery Technology Trends
    11.13.17

    Theravance Biopharma, Inc. and Mylan have partnered to submit a New Drug Application to the U.S. Food and Drug Administration for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist. The drug is a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease.

     

    The application is supported by the companies' Phase 3 program for revefenacin, which consisted of two replicate Phase 3 efficacy studies and a 12-month, open-label, active comparator safety study. In both studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in overall treatment effect on trough FEV1 after 12 weeks of dosing.

     

    "If approved, this product will further strengthen Mylan's expertise in nebulized respiratory therapies and bolster our commercial presence in the respiratory space. We look forward to our continued work with Theravance Biopharma and the FDA as we progress to final approval." said Mylan president, Rajiv Malik.

     

     

    Related Searches
    • Development
    • study
    • fda
    • Biopharma
    Suggested For You
    Inhaled Drug Delivery Trends Inhaled Drug Delivery Trends
    Boehringer-Ingelheim Boehringer-Ingelheim
    Generic Version of Symbicort Granted FDA Approval Generic Version of Symbicort Granted FDA Approval
    Aerosol Delivery Devices Market Aerosol Delivery Devices Market
    Inhaled Drug Delivery Technology Trends Inhaled Drug Delivery Technology Trends
    Mogene Mogene
    Know the Challenges of Biosimilar Manufacturing Know the Challenges of Biosimilar Manufacturing
    Flexible Manufacturing Strategies and Data Integrity Flexible Manufacturing Strategies and Data Integrity
    AAPS Annual Meeting Preview AAPS Annual Meeting Preview
    Novartis to Acquire Advanced Accelerator Applications Novartis to Acquire Advanced Accelerator Applications
    Sterile Manufacturing: Future Trends and Challenges Sterile Manufacturing: Future Trends and Challenges
    Contracting & Outsourcing Session Highlights and Key Takeaways Contracting & Outsourcing Session Highlights and Key Takeaways
    Filings and Fast Track/Breakthrough Designations Filings and Fast Track/Breakthrough Designations
    Envigo Makes Executive Appointments Envigo Makes Executive Appointments
    Know the Challenges of  Biosimilar Manufacturing Know the Challenges of Biosimilar Manufacturing

    Related Features

    • Drug Delivery
      Inhaled Drug Delivery Trends

      Inhaled Drug Delivery Trends

      Designing dry powder devices for inhaled drugs.
      Andreas M. Meliniotis, Director of Device Development, Vectura 09.09.21

    • Boehringer-Ingelheim

      Boehringer-Ingelheim

      ...
      07.16.21

    • Breaking News | Industry News
      Generic Version of Symbicort Granted FDA Approval

      Generic Version of Symbicort Granted FDA Approval

      Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
      Charles Sternberg, Assistant Editor 03.09.21


    • Drug Delivery
      Aerosol Delivery Devices Market

      Aerosol Delivery Devices Market

      Advantages over conventional drug delivery devices, rise in prevalence of COPD and asthma drive the growth of the global aerosol delivery devices market.
      Allied Market Research 02.16.21

    • Drug Delivery | Drug Development
      Inhaled Drug Delivery Technology Trends

      Inhaled Drug Delivery Technology Trends

      The success of new inhaled medicines relies on the correct combination of formulation and device technology.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20

    Loading, Please Wait..
    Trending
    • Steriline Provides Fill-Finish Solution For Berkshire Sterile Manufacturing
    • Thermo Fisher, Celltrio Partner On Cell Line Automation Platform
    • Bristol Myers Squibb 4Q Results
    • Astellas Announces New President And CEO And Management Structure
    • Bionova Expansion Project To Quadruple GMP Biologics Manufacturing Capacity
    Breaking News
    • ValiRx Signs Lease Deal with Nottingham Laboratories
    • Civica Partners with Ypsomed for Insulin Injection Pen
    • Charles River Laboratories Completes the Acquisition of SAMDI Tech
    • Selkirk Pharma Names New Director for Business Development
    • Center for Breakthrough Medicines Introduces Precision Plasmids Manufacturing
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • CDMOs in the Spotlight: Investing in Themselves
    • Extrusion-Spheronization in OSD Manufacturing
    • Modernizing Therapeutic Cell Production
    • Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold
    • Digital Transformation in Pharma
    • Fill-Finish in Cell & Gene Therapy
    • Early-Stage Biotechs: What’s Essential and What’s Not
    • Five Insights to Maximize Customer-Centric Acquisition Growth
    • Challenges in API Technical Transfer
    • 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

    ADM Expands Production to Meet Demand for Probiotics
    Wiley’s Finest Debuts Peak DHA Featuring 600 mg of DHA and 300 mg of EPA
    FDA to Allow Qualified CVD Risk Reduction Claim for Cocoa Flavanols in High Flavanol Cocoa Powder
    Coatings World

    Latest Breaking News From Coatings World

    Personnel Changes at BASF
    Dr. Kurt Wood to Deliver Mattiello Memorial Lecture at ACA’s 2023 CoatingsTech Conference
    hubergroup Chemicals to Debut at the European Coatings Show
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Konica Minolta Introduces Mobile X-Ray Systems to Latin America
    NIH MedTech Program Aims to Develop Neurological Treatment Tech
    Formula Plastics Appoints Bill Gerard as President
    Contract Pharma

    Latest Breaking News From Contract Pharma

    ValiRx Signs Lease Deal with Nottingham Laboratories
    Civica Partners with Ypsomed for Insulin Injection Pen
    Charles River Laboratories Completes the Acquisition of SAMDI Tech
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Tree Hut Introduces Body Wash Line
    Zara Introduces Mini Artists—Beauty Products for Kids
    L’Oréal USA Taps Stephanie Kramer as Chief Human Resources Officer
    Happi

    Latest Breaking News From Happi

    FTC Extends Public Comment Period on Potential Updates to Green Guides
    Arm & Hammer Taps Dave & Jenny Marrs, TikTokers for Budget-Centered 'Give It The Hammer' Campaign
    Meaningful Beauty Age-Proof Hair Care System Now Available on Amazon
    Ink World

    Latest Breaking News From Ink World

    Siegwerk, Wildplastic, TU-Hamburg Partner on Deinking
    Brilliant Group and Terra Firm Launch Partnership
    hubergroup Chemicals Debuts at the European Coatings Show
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    The Oldham Group names Doug McClure technical sales rep
    Siegwerk partnership aims to improve plastic waste recyclability
    CELAB-Europe launches new web hub for liner recyclers
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Toray to Expand PPS Production in Korea
    Masque Bar Launches Compostable Sheet Masks
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Jury Convicts Chiropractor, Orthopedic Surgeon in $31M Fraud Scheme
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Nedap Follows NRF Success with Showcase at EuroShop 2023
    NXP Semiconductors Reports 4Q, Full-Year 2022 Results
    Zebra Technologies Extends Partnership with the NFL

    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