Welcome to Marinduque-My Island Paradise

If this is your first time in my site, welcome! If you have been a follower, my heartfelt thanks to you, also. Help me achieve my dream, that someday, Marinduque will become a world tourist destination not only on Easter Week, but also whole year round. You can do this by telling your friends and relatives about this site. The photo above is Mt Malindig in Torrijos. Some of the photos and videos on this site, I do not own. However, I have no intention on the infringement of your copyrights. Cheers!

Marinduque Mainland from Tres Reyes Islands

Marinduque Mainland from Tres Reyes Islands
View of Mainland Marinduque from Tres Reyes Islands-Click on Photo to link to Marinduque Awaits You

Tuesday, November 18, 2025

Daily Reading Can Reduced Risk of AZD


A daily reading habit may do far more than sharpen the mind; it could actually protect it. Recent research shows that reading a book for as little as six minutes a day can reduce the risk of Alzheimer’s disease, enhance memory, and improve communication skills by keeping the brain active and resilient.
Scientists explain that reading engages multiple areas of the brain simultaneously, language processing, memory recall, imagination, and emotional regulation, creating a kind of mental workout that strengthens neural connections. Over time, this activity builds what researchers call cognitive reserve, a buffer that helps the brain resist age-related decline and neurodegenerative conditions like Alzheimer’s.
Just six minutes of focused reading has also been shown to lower stress levels by up to 68%, calm heart rate, and reduce muscle tension. This mental relaxation enhances overall brain function, making it easier to retain information, express ideas clearly, and manage emotions effectively.
Unlike scrolling or passive media, reading demands deep focus, stimulating both hemispheres of the brain and promoting new neuron growth. The result is improved memory retention, stronger vocabulary, and better emotional intelligence, even in older adults.
The takeaway is simple: reading doesn’t just expand knowledge, it preserves it. A few quiet minutes with a good book can help strengthen memory, sharpen communication, and build long-term brain protection, one page at a time.

Meanwhile,  here's a more personal write-up on the topic. I titled it,  Six Minutes to Remember

Every morning, before the day gathers its noise, I sit quietly with a book or a newspaper. Sometimes it’s a few pages of poetry, sometimes an article that stirs the mind and specifically AI technology news. It rarely lasts more than a few minutes, six perhaps and yet those six minutes have become my daily act of renewal.

A recent study says that reading for just six minutes a day can sharpen memory and even lower the risk of Alzheimer’s disease. I smiled when I read that. Science is finally confirming what the soul has long known that attention, curiosity, and imagination keep us alive in ways no medicine can.

When I read, I feel my mind stretch and soften at the same time. Words reach into places I didn’t know needed light. They pull me out of the narrowness of self and into the wider landscape of human thought. Each sentence is a gentle electric current, keeping the circuits of the mind alive.

And when I write these small daily reflections, my blog entries born of quiet mornings, it feels like the return half of the same breath. Reading fills me; writing releases me. One feeds memory, the other meaning. Together, they weave the fabric of my inner life.

Perhaps that’s why I read and write every day not merely to remember facts, but to remember myself. To remember what it feels like to be awake, to be moved, to still care about beauty and truth in a world that hurries past them.

Six minutes a day, that’s all it takes, they say. But maybe it’s not about time at all. Maybe it’s about the willingness to pause, to listen, to let the mind wander and wonder. In those brief moments, memory becomes more than a function of the brain, it becomes a quiet hymn to being alive.

For as long as I can read, and as long as I can write, I will not forget who I am.

My Food For Thought For Today:

https://www.facebook.com/reel/3913322285638878

Lastly, Moral of the Story



Finally, Here are five of the biggest news stories today:

  1. Trump Hosts Saudi Crown Prince Mohammed bin Salman in DC — Donald Trump is welcoming MBS to the White House for a major two-day visit. Talks are expected around defense deals (including F-35 jets) and a large Saudi investment pledge. The Guardian+2AP News+2

  2. UN Endorses Trump’s Gaza Peace Plan — The U.N. Security Council has approved a resolution backing Trump’s proposal, which includes deploying an international stabilization force and a potential pathway toward a Palestinian state. The Guardian+1

  3. Global Markets Rocked by Tech Volatility — Tech stocks dropped, Bitcoin slid, and investor concern spiked over high valuations and leverage. Nvidia is in focus ahead of its earnings. Reuters

  4. $60B Wiped From Australia’s Stock Market — The ASX fell sharply, driven by weak investor sentiment, and the sell-off rippled through major sectors. The Guardian

  5. COP30 Launches Without U.S. Participation — The 30th UN Climate Change Conference begins in Brazil, notably missing the U.S., raising questions about global climate action. Financial Times

Monday, November 17, 2025

Two of My Favorite Japanese Restaurants in Walnut Creek

For Details Visit Tatsu Sushi website: https://www.tatsusushiwalnutcreek.com/
  • The second restaurant, I just discovered recently ( via recommendation of Fellow
    residents here at THD)  is Tanoshi Bistro in Oak Grove Rd and Citrus.  Ditas and I 
    had dinner there last Sunday night. We were impressed by the Food Offerings and
    the prices were very reasonable compared to Tatsu. 

    I took some photos during our dinner as follows:








    Ditas and I came into the restaurant ONE minute before 5PM. We were seated in a
    more private area. We were served immediately our green tea with toasted rice💚.
    After 5:15PM, 
    the restaurant was filled with diners. By the time we finished our
     
    dinner at around 6PM, there was a line of 10 diners waiting outside and another 
    10 diners were waiting inside. For Details, visit their website:  


    Meanwhile, here are the Japanese food terms you should 
    know: Nigiri, sashimi and 
     sushi 
    rolls. 

    Nigiri is a type of sushi consisting of a hand-pressed oval of vinegared rice topped with a slice of raw or cooked seafood or other ingredientsThe name "nigiri" means "hand-pressed" in Japanese, and it is a classic style of sushi known for its simplicity, showcasing the balance between the rice and the topping.  
    • Construction
      A chef uses their hands to shape a small amount of sticky, vinegared rice into an oblong mound. A slice of topping, most often raw fish like tuna, salmon, or yellowtail, is then pressed onto the rice. 
    • Ingredients
      The topping is often fish, but can also include cooked seafood like shrimp or eel, or even vegetables or egg. A small dab of wasabi is sometimes placed between the rice and the topping, and a garnish may be added. 
    • Distinction from other sushi
      Nigiri is different from sashimi, which is just raw fish without rice. It also differs from sushi rolls, which are typically wrapped in seaweed and contain multiple ingredients inside. 
    • Artistry
      Nigiri is considered a true test of a sushi chef's skill, as it requires years of practice to consistently shape the rice and press the topping together to create a perfectly balanced, melt-in-your-mouth piece. 

    💚Green tea with toasted rice is called 
    Genmaicha, a popular Japanese green tea 
    that combines green tea leaves with roasted brown rice. The toasting process gives 
    the rice a nutty flavor that balances the grassy notes of the green tea, creating a 
    unique, comforting taste that is often described as having hints of popcorn or toast. 

    Meanwhile, My Photo of the Day_ Trump ( Banksy Art)
    Finally, My Food For Thought For Today: 

A New Dawn for Anti-Malarial Drug Therapy

Reflections from the FDA and a New Dawn for Antimalarial Therapy

When I think back to my years at the Food and Drug Administration, those many mornings reviewing  NDA's/IND's, the dozens of teleconferences, the guidance meetings, and the policy debates around antimalarial drug products, I’m reminded that progress in global health doesn’t come in neat, predictable increments. It comes in fits and starts, often decades apart, with spurts of innovation followed by long plateaus.

That is why last week news on a new anti-malarial drug is so meaningful to me. According to the last week issue of the The Wall Street Journal, Novartis has reported phase III data for a new antimalarial therapeutic, ganaplacide / lumefantrine (code-name “GanLum”)which achieved cure rates exceeding 99 % against uncomplicated Plasmodium falciparum malaria, including strains with emerging resistance. Finviz+4The Wall Street Journal+4Reuters+4

As someone who once handled, at the GS-14 level, policy and regulatory reviews (CMC) for antimalarial drug products, this moment resonates on multiple levels: scientifically, regulatorily, and personally.


The Modern Landscape of Antimalarial Drug Products

In the early 2000s, the worldwide standard of care for many falciparum malaria cases was an artemisinin-based combination therapy (ACT), such as artemether/lumefantrine (commercially known as Coartem). Resistance to older monotherapies had already been recognized, and the global health community rallied behind ACTs in large part because the mode of drug resistance for P. falciparum is notoriously adaptive. (For example, as early as ~2005, partnerships between Novartis and global funders aimed to assure supply of Coartem in malaria-endemic countries. Devex+1)

From a regulatory perspective at the FDA, each antimalarial submission demanded careful scrutiny:

  • Pharmacokinetics/pharmacodynamics, especially in vulnerable populations (children, pregnant women)

  • Safety profiles in settings with comorbidities, malnutrition, or co-infections

  • Resistance monitoring and contingency planning

  • Supply chain, stability, and distribution logistics (especially for endemic regions)

  • Labeling and use-cases in resource-limited settings

In my reviews, one of the recurrent concerns was: what happens when resistance begins eroding the efficacy of our best tools? The answer was that we needed a next-generation antimalarial sooner rather than later.


Why GanLum Represents a Significant Milestone

The new candidate, GanLum, is noteworthy for several reasons:

  • It uses a novel compound, ganaplacide, paired with a reformulated version of lumefantrine. Reuters+2Finviz+2

  • The mechanism of action appears distinct: ganaplacide disrupts the parasite’s internal protein transport system, and also targets the gametocyte stage, the form of the parasite responsible for transmission back to mosquitoes. The Wall Street Journal+2Reuters+2

  • In a large late-stage trial (1,688 adults and children across 12 African countries) the cure rate exceeded 97 % in intent-to-treat and exceeded 99 % in per-protocol analysis. Reuters+2Finviz+2

  • The fact that it retains efficacy against drug-resistant strains is critical when we consider the global threat of resistance spreading. The Wall Street Journal+1

  • Novartis and its partners are targeting access in high-resistance zones (for example, East & Southern Africa) and anticipate rollout within 12-18 months. Reuters+1

For a former regulator such as myself, this is a textbook case of what we hope for when we approve a new therapeutic: innovative mechanism, robust trial data, strong public health rationale, and a pathway to access. It is gratifying to see the pipeline delivering.


Reflecting on My FDA Years — What I Learned and How It Connects

During my time at the FDA, I had the opportunity to engage with antimalarial drug regulation in ways that were both technical and policy-oriented, including:

  • Reviewing IND/NDAs for antimalarial agents, often with global health partners.

  • Monitoring signals of emerging resistance and engaging in discussions about global pharmacovigilance.

  • Collaborating with program offices to ensure that approved therapies had labeling appropriate for low-resource settings and children.

  • Participating in advisory committee meetings where the questions were often “How will this therapy fit into our global eradication strategy?” or “What contingency plans are in place if resistance emerges?”

Looking back, a few lessons stand out:

  1. Innovative mechanism matters. We knew that simply tweaking existing molecules would buy time, but a real step-change required novel scaffolds and novel targets. Today’s ganaplacide is precisely that.

  2. Data in diverse populations is key. Trials that include children, pregnant women, various geographies, and resistant strains make regulation and implementation far stronger.

  3. Access and stewardship must go hand in hand. Approving a drug is one thing; ensuring equitable access, maintaining supply chains, and avoiding misuse (which could accelerate resistance) is another. In my FDA years I often emphasized that regulatory approval is only one part of the equation.

  4. Global health context changes the regulatory lens. Approvals for diseases of poverty or low-profit markets require emphasis on affordability, partnerships, and sometimes creative regulatory pathways (or “global health priority labels”).

  5. Resistance is the ever-present threat. Even the best drugs can become obsolete if resistance spreads unchecked. Thus, ongoing surveillance, combination therapies, and new pipelines need to be part of the long-term strategy.

In this sense, GanLum is more than simply “another antimalarial.” It embodies the hope that a regulator like myself once vigorously advocated for a pipeline that doesn’t just respond to the latest threat but leaps ahead.


What’s Next — Implementation and Regulatory Considerations

From where I sit now, and drawing on my former regulatory experience, here are a few key issues to watch as GanLum moves toward approval and deployment:

  • Regulatory submission and review: What will the dossier look like for WHO pre-qualification, EMA review, or FDA programs (e.g., priority review for neglected diseases)? The former regulator in me will be curious about the safety database, pediatric formulation, and how resistance data are handled.

  • Labeling and population subsets: Will this therapy be approved for children (including infants?), pregnant women, and in areas of high resistance? One notes that many antimalarial programs struggle with the “last mile” of wrapping in vulnerable populations.

  • Formulation, dosing, and operational use: The data mention sachets and once-daily dosing for three days. From a field logistics standpoint, simpler dosing improves adherence. How well will this translate into real-world use in remote settings?

  • Access and affordability: Novartis has indicated non-profit or near-cost models in endemic regions. That is encouraging. The regulatory interface must ensure that the approved product is affordable and distributed in alignment with public-health priorities.

  • Surveillance and stewardship: With any new antimalarial, it’s critical that monitoring for emerging resistance begins immediately. Regulatory authorities (and funding agencies) need to ensure guidelines for usage, combination therapies, and retention of efficacy.

  • Integration with global eradication efforts: The new drug will not stand alone. Vaccines, vector control (e.g., bed nets, insecticides), diagnostics, and health-systems strengthening must all interface with the rollout of a new therapeutic.


A Personal Note and Looking Ahead

I recall afternoons in the FDA review room when we debated whether a molecular target was sufficiently differentiated, whether the global health burden justified priority review, whether the trial design captured the “real-world” use in Africa or Asia. At times, that work felt slow or incremental. But these efforts were laying the groundwork for exactly the kind of breakthrough we’re now witnessing.

For me, this new news reignites the memory of those years—not just as a regulator enforcing standards, but as a public-servant contributing to a larger mission: reducing suffering from infectious disease, especially among the world’s poorest and most vulnerable.

And now, as GanLum nears potential approval, I am filled with cautious optimism. It reminds me that regulation is not merely bureaucratic gate-keeping; it’s part of a chain of innovation, public health, and global equity. It reminds me also that the work I did and the work of countless colleagues at the FDA and beyond matters.

In closing, I offer my heartfelt hope that this new therapy will reach those who need it most, that implementation will be swift and equitable, and that this moment becomes a tangible leap in the fight against malaria. If I were still at the FDA, I’d be talking with colleagues: “Here is the new asset. Let’s ensure iron-clad post-approval monitoring. Let’s coordinate with WHO, funders, and countries to get it into arms. Let’s protect its lifespan by stewardship.” Because from regulator to implementer to patient, we all share the goal: fewer deaths, fewer children lost, fewer lives disrupted by a preventable disease.

Thank you for reflecting with me. The journey continues and in this moment, it feels like one of those meaningful leaps.

Meanwhile, here are three of my previous postings on Anti-Malarial Drug Products 

https://chateaudumer.blogspot.com/2019/10/drugs-for-treatment-of-malaria.html

https://chateaudumer.blogspot.com/2021/07/our-maryland-and-fda-years-1990-2002.html

https://chateaudumer.blogspot.com/2018/08/fda-approved-drugs-for-2018-new-anti.html

  1. Epstein Files Controversy — Republican Rep. Thomas Massie and Democrat Ro Khanna are pushing for the release of previously undisclosed government files on Jeffrey Epstein. Massie accuses former President Trump of launching a probe to shield documents. The Guardian

  2. U.S. Military Strike in Eastern Pacific — The U.S. conducted an operation against an alleged drug-smuggling vessel in the eastern Pacific, killing three people onboard, according to the Pentagon. The Guardian

  3. Zelenskiy Visits Paris — Ukrainian President Volodymyr Zelenskiy is meeting with French President Emmanuel Macron in Paris to reinforce France’s support amid ongoing conflict with Russia. Reuters

  4. Leonid Meteor Shower Peaks — The annual Leonid meteor shower, known for its fast and bright meteors, is expected to peak on the night of Nov 16–17, offering a great skywatching opportunity. The Times of India

  5. Safer Gambling Week Begins — The UK and Ireland launch Safer Gambling Week (Nov 17–23), spotlighting responsible gambling tools and support services. TalkSport

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