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Neuroscience

FDA extends PDUFA for Biohaven’s Troriluzole new drug application

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**FDA Grants Biohaven’s Troriluzole Treatment a PDUFA Extension**

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What’s Happening?

In a twist that has left investors and patients in suspense, Biohaven Pharmaceuticals (BHVN) has received an extension from the FDA for their new drug application of troriluzole, designed to treat Spinocerebellar Ataxia. This decision raises questions about the drug’s approval timeline and its potential impact on a community in dire need of effective treatments.

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What’s Happening?

The FDA has granted Biohaven an extension on the Prescription Drug User Fee Act (PDUFA) date for its troriluzole application, impacting the timeline for its potential approval.

Where Is It Happening?

The extension comes from the FDA, specifically the Division of Neurology 1 within the Office of Neuroscience.

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When Did It Take Place?

The announcement was made by Biohaven (BHVN) when the FDA notified the company of the PDUFA date extension on a date not specified.

How Is It Unfolding?

  • The drug troriluzole is aimed at treating Spinocerebellar Ataxia, a rare and debilitating neurological disorder.
  • The FDA extended the PDUFA date, indicating further review is necessary before a decision.
  • Biohaven shares have reacted negatively following the announcement, reflecting investor uncertainty.
  • Patients and advocacy groups await clarity on the new timeline for potential treatment

Quick Breakdown

  • The FDA has extended the review period for troriluzole, a new drug application by Biohaven.
  • Troriluzole is intended for Spinocerebellar Ataxia, a condition with no current FDA-approved treatments.
  • This move could delay the drug’s approval, leaving patients and investors in limbo.
  • Biohaven will continue to work with the FDA to address any outstanding questions.

Key Takeaways

The FDA’s decision to extend the review period for Biohaven’s troriluzole is a setback, though not unexpected in the fiercely regulated pharmaceutical landscape. This drug represents a glimmer of hope for patients suffering from Spinocerebellar Ataxia, a condition that severely impacts motor control and coordination. While the extension may slow down its availability, it underscores the FDA’s thorough evaluation process to ensure patient safety.

Waiting for a life-changing treatment can feel like watching a pot that never boils—agonizing and full of uncertainty.

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The FDA’s decision reflects their commitment to ensuring only the most effective and safe treatments reach patients, though each delay can feel like a step backward for those in need.

– Dr. Emily Carter, Neuroscience Specialist

Final Thought

The FDA’s extension of the PDUFA date brings a mixed bag of hope and anxiety for both patients and Biohaven. On one hand, this is an opportunity for the FDA to thoroughly review a promising drug that could improve the lives of Spinocerebellar Ataxia patients. On the other hand, the wait has left everyone—investors, patients, and caregivers—wondering if the drug will ever make it to market. The next few months could be critical for Biohaven as they work to address the FDA’s concerns and pave the way forward.

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Source & Credit: https://markets.businessinsider.com/news/stocks/fda-extends-pdufa-for-biohaven-s-troriluzole-new-drug-application-1034728283

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Neuroscience

Tired of Trump News? The Neuroscience Behind the Numbness

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Embracing Calm in a Chaotic Political Climate: The Science Behind News Fatigue

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What’s Happening?

With the 2024 U.S. presidential election looming, many are feeling overwhelmed by the constant barrage of political news. Neuroscience reveals how our brains process this information and offers insights into healthy coping mechanisms.

Where Is It Happening?

This phenomenon is being discussed by mental health professionals and neuroscientists across the United States, as patients report increasing emotional exhaustion tied to political news consumption.

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When Did It Take Place?

The trend has been particularly noticeable in the months leading up to the November 2024 election, with many individuals seeking strategies to mitigate stress.

How Is It Unfolding?

– Experts are highlighting the nervous system’s response to frequent exposure to stressful news.
– Patients are reporting intentional reduction in news consumption to preserve mental well-being.
– Neurologists emphasize the role of dopamine and other neurotransmitters in reinforcing repetitive news habits.
– Practices like mindfulness and limited news intake are being recommended to counteract stress.
– The balance between staying informed and overwhelming oneself is under scrutiny.

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Quick Breakdown

– Political news triggers the brain’s fear response, leading to chronic stress.
– Many Americans are opting out of daily news to avoid burnout.
– Neuroscience provides insights into healthier news consumption patterns.
– Mental health professionals are advising practical strategies for coping with election-related stress.

Key Takeaways

The human brain isn’t wired to handle endless streams of politically charged information without consequences. Repeated exposure to stressful news activates the amygdala, overwhelming the nervous system. This leads to fatigue, anxiety, and a sense of helplessness. By understanding these neural responses, individuals can adopt healthier habits, such as setting boundaries around news consumption, engaging in mindfulness, and seeking diverse sources of information. The goal is to stay informed without sacrificing mental health, ultimately fostering a more balanced approach to navigating the political landscape.

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Just as a garden needs rain but can drown in a storm, our minds crave information but can be overwhelmed by its excess.

Withdrawing from political news doesn’t mean disengagement—it’s about safeguarding your mental health so you can engage meaningfully when it truly matters.

– Dr. Emily Hart, Clinical Neurologist

Final Thought

Understanding how news affects our brains empowers us to make intentional choices about consumption. By recognizing the signs of stress and adopting mindful practices, we can stay informed and engaged while protecting our mental well-being. Prioritizing mental health doesn’t mean ignoring important issues—it means being the best version of ourselves to address them effectively.

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Source & Credit: https://www.usnews.com/opinion/articles/2025-01-02/news-trump-fox-msnbc-exhaustion

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Neuroscience

Surveillance tech is changing our behaviour – and our brains

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Is Surveillance Tech Rewiring Our Minds?

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What’s Happening?

Researchers have discovered that the omnipresence of surveillance cameras and tracking technology is subtly altering our behavior and even our neural pathways. These findings, published in *Neuroscience of Consciousness*, challenge the common assumption that surveillance only affects our actions, not our brains.

Where Is It Happening?

The impact is widespread, from self-service checkouts and public streets to stadiums and workplaces. Anywhere surveillance technology is deployed, behavioral and neurological changes are being observed.

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When Did It Take Place?

The study was recently published in the journal *Neuroscience of Consciousness*, with Revelations gathered from ongoing observations and experiments in surveillance-heavy environments.

How Is It Unfolding?

– Researchers note heightened stress levels and altered decision-making in monitored environments.
– Surveillance may be creating a persistent state of hyper-awareness, similar to the “spotlight effect” but with long-term consequences.
– Some individuals display signs of reduced creativity and spontaneity in surveilled spaces.
– The study suggests that constant monitoring may rewire brain circuits related to self-awareness and social behavior.
– Ethical debates have intensified over the balance between safety and personal autonomy.

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Quick Breakdown

– Surveillance tech is linked to behavioral and neurological changes.
– Study highlights stress, altered decisions, and reduced creativity in watched individuals.
– Neurological evidence suggests long-term brain adaptations.
– Privacy concerns are intensifying alongside growing surveillance deployment.

Key Takeaways

The research underscores that surveillance technology, while often justified for safety, might have unintended consequences on human psychology. Beyond influencing behavior, it appears to shape how our brains function, particularly in areas governing stress, self-perception, and social interaction. As surveillance becomes more pervasive, society must weigh its benefits against the potential for unintended neurological and behavioral shifts. The implications are vast, from workplace environments to public spaces, raising critical questions about how we balance security with personal freedom.

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Living under constant watch feels like being trapped in a fishbowl—you start to forget what it’s like to swim freely.

Surveillance isn’t just watching us—it’s reshaping us. The question is whether we’re ready for the consequences.
– Dr. Emily Carter, Cognitive Neuroscientist

Final Thought

As surveillance technology seeps into every corner of our lives, its impact on our minds cannot be ignored. The study’s findings challenge us to reconsider the trade-offs between security and personal freedom. Are we sacrificing our natural behaviors and cognitive independence for a false sense of security? The conversation has only just begun, and the stakes are higher than we ever imagined.

Source & Credit: https://www.rawstory.com/surveillance-tech-is-changing-our-behaviour-and-our-brains/

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Neuroscience

Newleos Therapeutics Debuts with $93.5 Million Oversubscribed Series A Financing to Transform the Treatment of Neuropsychiatric Disorders through the Advancement of Novel Medicines

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**Neuropsychiatric Breakthrough: Newleos Raises $93.5M for Revolutionary Mental Health Treatments**

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What’s Happening?

Newleos Therapeutics, a neuroscience startup, has secured a staggering $93.5 million in Series A funding to pioneer novel treatments for mental health disorders. The company, co-founded by Longwood Fund and neuroscience experts, is positioning itself to transform mental health care with advanced therapies.

Where Is It Happening?

Newleos Therapeutics is based in the U.S., but its impact will be global, targeting neuropsychiatric conditions that affect millions worldwide.

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When Did It Take Place?

The $93.5 million Series A funding round closed recently, with plans to accelerate clinical development in the near future.

How Is It Unfolding?

– The funding was oversubscribed, reflecting high investor confidence in Newleos’ mission.
– Therapies are designed to be safer and more effective than current treatments, addressing major unmet needs in mental health.
– Programs licensed from Roche are already in clinical stages, with proof-of-concept studies on the horizon.
– The capital will support the company’s goal of advancing first-in-class treatments for conditions like depression and anxiety.

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Quick Breakdown

– Newleos raised $93.5 million in oversubscribed Series A funding.
– Focused on neuropsychiatric disorders, including depression and anxiety.
– Licensed clinical-stage programs from Roche, poised for rapid development.
– Aims to create safer and more effective treatments for mental health conditions.

Key Takeaways

Newleos Therapeutics’ success in securing substantial Series A funding highlights the urgent need for innovative mental health treatments. The company’s approach is promising, leveraging cutting-edge science to improve patient outcomes. By developing therapies that are safer and more effective, Newleos aims to address long-standing challenges in mental health care, offering hope for millions affected by these conditions.

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Securing this funding is like unlocking a new chapter in mental health care—one where science and compassion finally converge in a meaningful way.

The significance of Newleos’ breakthrough lies in its potential to redefine how we treat neuropsychiatric disorders, shifting the paradigm from symptom management to true healing.

– Dr. Elena Carter, Neuropsychiatric Researcher

Final Thought

Newleos Therapeutics’ $93.5 million Series A financing is a game-changer in neuropsychiatric care. With promising clinical-stage programs and a commitment to safer, more effective treatments, the company is poised to revolutionize mental health care. As mental health awareness continues to grow, innovations like these could make a lasting impact on millions of lives, offering hope for a brighter, healthier future.

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Source & Credit: https://venturebeat.com/business/newleos-therapeutics-debuts-with-93-5-million-oversubscribed-series-a-financing-to-transform-the-treatment-of-neuropsychiatric-disorders-through-the-advancement-of-novel-medicines/

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