* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Saturday, September 6, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

    Jenny Han Dropped a Major ‘The Summer I Turned Pretty’ Easter Egg Revealing [SPOILER] – yahoo.com

    Jenny Han Just Unveiled a Huge ‘The Summer I Turned Pretty’ Easter Egg That Changes Everything [SPOILER]

    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Coherent Joins LLNL’s STARFIRE Diode Technology Working Group to Advance Inertial Fusion Energy – GlobeNewswire

    Coherent Partners with LLNL’s STARFIRE Team to Drive Breakthroughs in Inertial Fusion Energy

    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    Monkey Island LNG Picks ConocoPhillips’ Liquefaction Technology – Hart Energy

    Monkey Island LNG Selects ConocoPhillips’ Advanced Liquefaction Technology for Next-Gen Energy Solutions

    Credo Technology Group Holding Ltd. (CRDO) Surpasses Q1 Earnings and Revenue Estimates – Yahoo Finance

    Credo Technology Group Surpasses Q1 Earnings and Revenue Expectations

    The Economist is hiring a science and technology correspondent – The Economist

    Exciting Opportunity: Become Our Next Science and Technology Correspondent!

    Blockchain lender Figure Technology seeks to raise up to $526M in IPO (FIGR:Pending) – Seeking Alpha

    Blockchain Lender Figure Technology Sets Sights on $526M in Thrilling IPO Launch

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

    Jenny Han Dropped a Major ‘The Summer I Turned Pretty’ Easter Egg Revealing [SPOILER] – yahoo.com

    Jenny Han Just Unveiled a Huge ‘The Summer I Turned Pretty’ Easter Egg That Changes Everything [SPOILER]

    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Coherent Joins LLNL’s STARFIRE Diode Technology Working Group to Advance Inertial Fusion Energy – GlobeNewswire

    Coherent Partners with LLNL’s STARFIRE Team to Drive Breakthroughs in Inertial Fusion Energy

    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    Monkey Island LNG Picks ConocoPhillips’ Liquefaction Technology – Hart Energy

    Monkey Island LNG Selects ConocoPhillips’ Advanced Liquefaction Technology for Next-Gen Energy Solutions

    Credo Technology Group Holding Ltd. (CRDO) Surpasses Q1 Earnings and Revenue Estimates – Yahoo Finance

    Credo Technology Group Surpasses Q1 Earnings and Revenue Expectations

    The Economist is hiring a science and technology correspondent – The Economist

    Exciting Opportunity: Become Our Next Science and Technology Correspondent!

    Blockchain lender Figure Technology seeks to raise up to $526M in IPO (FIGR:Pending) – Seeking Alpha

    Blockchain Lender Figure Technology Sets Sights on $526M in Thrilling IPO Launch

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

FDA Delays Decision on Alzheimer’s Hopeful Donanemab

March 9, 2024
in Health
FDA Delays Decision on Alzheimer’s Hopeful Donanemab
Share on FacebookShare on Twitter

The US Food and Drug Administration (FDA) has put off a decision expected this month on whether to approve donanemab for Alzheimer’s disease (AD). 

Instead, the FDA will convene a meeting of outside experts to discuss the phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic AD.

In a statement, Eli Lilly said the FDA informed the company that it wants to “further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.”

“It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab’s strong efficacy in the context of safety,” Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in a statement.

The date of the FDA advisory committee meeting to review the donanemab data has yet to be set, which means a decision on the drug will go beyond the first quarter of 2024, when the decision was expected. 

The TRAILBLAZER-ALZ 2 study showed that donanemab significantly slowed cognitive and functional decline in patients with early, symptomatic AD in comparison with placebo.

The key risk associated with donanemab (as with other antiamyloid agents) is amyloid-related imaging abnormalities (ARIAs) — which occurred in 36.8% of the treatment group vs 14.9% of the placebo group, and in 40.6% of patients who were homozygous for APOE e4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group vs 12.5% in the placebo group.

Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug-related among participants who developed serious ARIAs or brain bleeding and swelling.

As previously reported by Medscape Medical News, the TRAILBLAZER-ALZ 2 results were presented at the Alzheimer’s Association International Conference 2023 and simultaneously published online on July 17 in JAMA. 

In a statement sent to Medscape Medical News, Howard Fillit, MD, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the FDA decision to convene an advisory meeting on donanemab is “not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients.”

“The TRAILBLAZER-ALZ 2 trial is emblematic of a new era of Alzheimer’s research where we are now able to conduct innovative trials that can definitively tell us whether a drug is effective. As the first class of Alzheimer’s drugs come to market—with the promise of more novel therapies to follow—the field is working together to build the path forward for future drug approvals,” Fillit said.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/fda-delays-decision-alzheimers-hopeful-donanemab-2024a10004i7

Tags: DecisionDelayshealth
Previous Post

Anti-DEI Petition Sparks Conflict at Nat’l Derm Meeting

Next Post

A Better Way to Assess Glaucoma?

Blending art, culture and native plants at Wakamatsu – Mountain Democrat

Discover the Harmony of Art, Culture, and Native Plants at Wakamatsu

September 6, 2025
The Two-Body Problem for Women in Science – Nautilus | Science Connected

The Two-Body Problem for Women in Science – Nautilus | Science Connected

September 6, 2025
How AI and Automation are Speeding Up Science and Discovery – Berkeley Lab News Center (.gov)

How AI and Automation Are Accelerating Breakthroughs in Scientific Discovery

September 6, 2025

American Trust Investment Services Serves as Exclusive Placement Agent in $9 Million Follow-On Offering for Nova LifeStyle, Inc. – Morningstar

September 6, 2025
Coherent Joins LLNL’s STARFIRE Diode Technology Working Group to Advance Inertial Fusion Energy – GlobeNewswire

Coherent Partners with LLNL’s STARFIRE Team to Drive Breakthroughs in Inertial Fusion Energy

September 6, 2025
EA SPORTS™ and New York City FC Extend Partnership to Power the Future of Football Fandom in NYC – New York City FC

EA SPORTS™ and New York City FC Join Forces to Transform Football Fandom in NYC

September 6, 2025
News – Ancient DNA Pinpoints Culprit Responsible for World’s First Pandemic – Archaeology Magazine

Ancient DNA Reveals the True Cause of the World’s First Pandemic

September 5, 2025
Fears of US recession as economy adds just 22,000 jobs – The Times

Fears of US recession as economy adds just 22,000 jobs – The Times

September 5, 2025
Musiq Soulchild Surprises Fan’s Bride With “Dontchange” Wedding Serenade – yahoo.com

Musiq Soulchild Captivates Wedding Guests with Heartfelt Serenade of “Don’tchange

September 5, 2025
States fight feds over future of school mental health services – Courthouse News Service

States Clash with Federal Government Over the Future of School Mental Health Services

September 5, 2025

Categories

Archives

September 2025
MTWTFSS
1234567
891011121314
15161718192021
22232425262728
2930 
« Aug    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (809)
  • Economy (827)
  • Entertainment (21,704)
  • General (16,879)
  • Health (9,868)
  • Lifestyle (840)
  • News (22,149)
  • People (829)
  • Politics (834)
  • Science (16,038)
  • Sports (21,326)
  • Technology (15,808)
  • World (808)

Recent News

Blending art, culture and native plants at Wakamatsu – Mountain Democrat

Discover the Harmony of Art, Culture, and Native Plants at Wakamatsu

September 6, 2025
The Two-Body Problem for Women in Science – Nautilus | Science Connected

The Two-Body Problem for Women in Science – Nautilus | Science Connected

September 6, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version