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

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

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

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

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

GSK’s Breo for asthma? FDA panel says yes–but only in adults

Yuvraj_pawp by Yuvraj_pawp
19th March 2015
in FDA Approvals

Good news for GlaxoSmithKline ($GSK): An FDA panel of experts says the efficacy and safety data for blockbuster wannabeBreo support the asthma indication it’s gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? The panelists aren’t having it.

On Thursday, the agency’s advisory committee voted 16-4 in favor of green-lighting the med to treat asthmatic adults. But when it came to assessing Breo in younger patients, it turned the drug down by an 18-2 measure–and one of the two “yes” votes was cast accidentally, the FDA said.

Even if the FDA does follow the committee’s lead and expand Breo’s label in adults–a decision that’s due by the end of April–its nod may come with some caveats. The panel voted in favor of requiring a large LABA safety trial for the drug, similar to the ongoing trials the FDA requires for on-the-market asthma meds like Glaxo’s aged Advair.

Still, it’s a good sign for Glaxo, which is hoping the asthma approval can help slow-starter Breo really get moving. The med is one of a handful of respiratory up-and-comers that’ll need to produce for the pharma giant if it hopes to even approach filling the giant shoes of $8-billion-a-year Advair, whose downward spiral has already begun.

Meanwhile, though, GSK chief Andrew Witty says the therapy–and fellow respiratory new kid Anoro–are picking up steam in the COPD market. “I am not saying to you on this call (that) I hope to see market share increase for respiratory–I am telling you the market shares have begun to go up in the last few weeks,” he told investors on a conference call last month.

Whether that can last, though, remains to be seen. “What I am not guaranteeing is exactly how that is going to play out for the rest of the year,” he said.

Tags: Europe
Previous Post

GSK becomes partner in new global fund to accelerate dementia research

Next Post

Merck KGaA to tap Oschmann as new CEO

Related Posts

FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Gavi, the Vaccine Alliance, Collaborates with Salesforce to Help Equitably Distribute Two Billion COVID-19 Vaccines by the End of 2021
FDA Approvals

WHO grants prequalification GC Biopharma’s varicella vaccine, Barycela

21st February 2023
FDA Approvals

In An FDA First, Cardiac Gene Therapy Given RMAT Status

13th February 2023
FDA Approvals

Drug Inspection Pact Between Switzerland And United States

17th January 2023
Usual Pharma Compliance Issues Noted In FDA Warning Letters
FDA Approvals

5 FDA Rulings To Keep An Eye On In The 2023 First Quarter

13th January 2023
FDA Approvals

First Treatment For Advanced ASPS Is Given The Green Light

4th January 2023
Next Post

Merck KGaA to tap Oschmann as new CEO

Latest News

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
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.

Qucik Links

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

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • 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