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    Massive Attack Say They’ll Remove Music From Spotify – yahoo.com

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    Bucking the Odds: Why Technology Companies Should Embrace Software Patents Today – Crowell & Moring LLP

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    Massive Attack Say They’ll Remove Music From Spotify – yahoo.com

    Massive Attack Announces Plans to Pull Their Music from Spotify

    REO to return for UI homecoming – The News-Gazette

    REO Gears Up to Ignite the Stage at UI Homecoming Celebration!

    Gen V Season 2: What is The Odessa Project? – yahoo.com

    Gen V Season 2: Unlocking the Secrets of The Odessa Project

    PENN Entertainment stock rating reiterated at Market Outperform by JMP – Investing.com

    PENN Entertainment Stock Rated a Market Outperformer by Experts

    Here’s how NJ’s once-vibrant nightclub scene was born and why it died – Bergen Record

    The Rise and Fall of New Jersey’s Once-Vibrant Nightclub Scene: What Happened?

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

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    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

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    China says US TikTok deal a ‘win-win’, will review app’s technology and IP transfers – Reuters

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    Bucking the Odds: Why Technology Companies Should Embrace Software Patents Today – Crowell & Moring LLP

    Bucking the Odds: Why Technology Companies Should Embrace Software Patents Today – Crowell & Moring LLP

    City IT presented Best of North Carolina Technology Award – RaleighNC.gov

    City IT Honored with Best of North Carolina Technology Award

    LELO Releases 2025 Futurist Report: Intergenerational Views on Relationships, Sex, and Technology – PR Newswire

    Exploring the Future: How Different Generations View Relationships, Sex, and Technology in 2025

    Will New Big Technology Engagements Reshape Innodata’s Growth Path? – Yahoo Finance

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FDA Staff Questions Safety of MDMA Treatment for PTSD

June 1, 2024
in Health
FDA Staff Questions Safety of MDMA Treatment for PTSD
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FDA staff raised concerns about the available safety data and limitations in the study design for midomafetamine (MDMA) to treat post-traumatic stress disorder (PTSD) in briefing documents released ahead of an FDA Psychopharmacologic Drugs Advisory Committee (PDAC) meeting.

If eventually approved by the agency, Lykos Therapeutics’ MDMA could become a first-in-class treatment for PTSD, which affects an estimated 5% of the U.S. population in any given year, according to the Veterans’ Administration National Center for PTSD. While PTSD can be treated with selective serotonin reuptake inhibitors (SSRIs), FDA staff noted that response rates with these drugs rarely exceed 60%, and typically less than 20% to 30% of patients achieve full remission.

“Thus, there remains an unmet need for additional options for safe and effective therapies to treat PTSD,” the FDA reviewers wrote.

The agency will ask the PDAC to discuss several major points during the June 4 meeting. The committee will first focus on efficacy, including the potential effect of functional unblinding on the interpretability of efficacy results, the durability of effects, and the role of psychotherapy in the treatment paradigm. It will assess the adequacy of the safety characteristics of MDMA, and review the potential for patient impairment or serious harm from treatment. In addition, the PDAC will weigh in on a proposed risk mitigation strategy to prevent serious patient harms related to MDMA treatment.

Two phase III trials conducted have assessed the efficacy and safety of MDMA in PTSD. Both studies, MAPP1 and MAPP2, were randomized, double-blind, placebo-controlled trials that included 91 and 104 participants with PTSD, respectively. Participants received three dosing sessions of MDMA with additional psychological support sessions before and after dosing.

In both trials, the MDMA arm experienced statistically significantly greater improvement in PTSD symptoms based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score.

In MAPP1, the MDMA and psychotherapy group saw an average drop in CAPS-5 score of 24.4 points, while those receiving psychotherapy alone saw an average drop of 13.9 points. In MAPP2, patients in the MDMA arm had a least-squares mean change of -23.7 in CAPS-5 score compared with -14.8 for those in the placebo arm (P
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The Economy Is Turning Into a Black Box – The Atlantic

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September 18, 2025
Massive Attack Say They’ll Remove Music From Spotify – yahoo.com

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Ex-UC Health doctor who performed genital ultrasounds in his apartment sentenced to jail – Cincinnati Enquirer

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September 18, 2025

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Klutch Sports Group Signs Maria Taylor – Variety

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September 18, 2025
Historic chills fit in nicely at Old World Wisconsin’s Halloween special program – Milwaukee Journal Sentinel

Historic chills fit in nicely at Old World Wisconsin’s Halloween special program – Milwaukee Journal Sentinel

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