X
Pharma Advancement
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Clinical Development

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

    AstraZeneca Eyes Acquisition To Develop Cell Therapies

    Advanced Instruments All Set To Merge With Nova Biomedical

    Taiho Pharmaceutical Buys Araris Biotech AG For $740 Million

    Oracle Wins the Asia Pacific Biopharma Excellence Awards

    Continuous Manufacturing is Improving Biopharma Production

    AI in Drug Commercialization Market to Grow CAGR 24% by 2032

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Clinical Development

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

    AstraZeneca Eyes Acquisition To Develop Cell Therapies

    Advanced Instruments All Set To Merge With Nova Biomedical

    Taiho Pharmaceutical Buys Araris Biotech AG For $740 Million

    Oracle Wins the Asia Pacific Biopharma Excellence Awards

    Continuous Manufacturing is Improving Biopharma Production

    AI in Drug Commercialization Market to Grow CAGR 24% by 2032

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

GSK’S B vaccine prevents harmful disease among children; U.S FDA applauds

Content Team by Content Team
9th February 2018
in FDA Approvals, Press Statements

GlaxoSmithKline plc announced that it has received Breakthrough Therapy Designation from the U.S. FDA for its meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of Invasive Meningococcal Disease (IMD) caused by serogroup B in children 2-10 years of age.

Bexsero is the first vaccine in the world to receive the Breakthrough Therapy Designation (BTD) twice. In 2014, Bexsero received BTD for development in the prevention of IMD in individuals 10-25 years of age and was subsequently granted Accelerated Approval in January 2015.

GSK Vaccines Chief Scientist Rino Rappuoli, who spent more than 20 years developing Bexsero, said: “This designation emphasises the importance of tackling big scientific challenges like meningitis B and breaking new ground in disease prevention through approaches like reverse vaccinology. GSK is committed to the pursuit of innovative vaccines that help protect against serious diseases with significant unmet need.”

Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, including more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

GSK Vaccines Chief Medical Officer Dr Thomas Breuer said: “Thirty-five percent of all meningitis B cases in the US occur in children under 11 years old.3 This designation is an important step forward in meningococcal prevention and extending the protection provided by this vaccine to a vulnerable age group in the US. We look forward to continuing to work with regulators and public health partners to make this vaccine available for them.”

Previous Post

Janssen Pierce To Globally Collabrate With Theravance Biopharma For Oral, Pan-Jak Inhibitor Drug Candidate For The Treatment Of Inflammatory Bowel Disease

Next Post

Kanuma ensuressurvival from Lysosomal Acid Lipse Deficiency; A Liver Disease

Related Posts

ACHEMA
Middle East and South Asia

ACHEMA Middle East to Debut in Riyadh in 2026 Trade Show

9th May 2025
Press Statements

APM Steam Highlights Comprehensive HVAC Insulation Services for Biopharmaceutical and Pharmaceutical Facilities

19th April 2025
Drug Development

Global Biopharma Market to Hit $566B by 2032

7th March 2025
Americas

Thermo Fisher to acquire Solventum’s Purification & Filtration business for US$4.1bn

4th March 2025
Drug Development

Celonic Group Signs Long-Term Multi-Year Manufacturing Service Agreement with LINDIS Biotech for the Commercial Supply of Catumaxomab

4th March 2025
Drug Development

Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront

4th March 2025
Next Post
Kanuma ensuressurvival from Lysosomal Acid Lipse Deficiency; A Liver Disease

Kanuma ensuressurvival from Lysosomal Acid Lipse Deficiency; A Liver Disease

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In