Latest Stories

Most recently published stories in Journal.

How Small and Mid-Sized Businesses Can Compete on Compliance
Key Takeaways: Compliance gaps usually aren’t about negligence; they’re about bandwidth, influenced by unclear ownership, records scattered across five different folders, and training that happens when someone finally gets around to it. A risk-based approach beats trying to copy what the big guys do. Small teams need simple routines. Think of compliance as infrastructure, not something you panic about before an inspection.
By William Powell5 days ago in Journal
Enrolling in a quality preschool sets children up for future academic success
Enrolling in a quality Busby preschool sets children up for future academic success by giving them a strong foundation during the most important years of development. Early childhood is a critical period when young minds are highly receptive to learning, social interaction, and structured routines. A well-designed preschool environment introduces children to learning positively and engagingly, helping them build confidence and curiosity before they enter formal schooling.
By Being Early Education6 days ago in Journal
Living With Purpose in the Wild: The Perspective of Erick Anthony Rossi. AI-Generated.
Rediscovering Stillness in a Restless World Modern life often moves at an unrelenting pace. Digital connectivity, demanding schedules, and constant information streams leave little space for quiet reflection. In contrast, the natural world follows rhythms that cannot be hurried. Seasons unfold gradually, wildlife moves according to instinct, and outcomes are shaped by conditions beyond human control.
By Anthony Rossi6 days ago in Journal
Operational Strategy and Manufacturing Resilience: Kenneth Kremsky Philadelphia. AI-Generated.
Manufacturing organizations operate under continuous pressure. Global competition, rapid technological advancement, workforce constraints, and evolving customer expectations require facilities to perform at consistently high levels. Companies must deliver reliable quality, maintain cost control, and adapt quickly to shifting demand patterns.
By Kenneth Kremsky6 days ago in Journal
Strategic Excellence in Pharmaceutical Product Management: Onyekachi Chidiadi. AI-Generated.
Breakthrough medicines often receive public attention, yet the strategic infrastructure guiding those medicines determines whether innovation meaningfully reaches patients. Pharmaceutical product management plays a vital role in connecting research, regulation, and real-world healthcare delivery. It ensures that therapies are introduced responsibly, supported appropriately, and sustained over time within a highly regulated environment.
By Onyekachi Chidiadi6 days ago in Journal
Japanese habits and lifestyle.
Many cultures have different types of gems to share with the world around us. What if we open our hearts and minds to new ideas. Are we willing to peek through the keyhole at other lifestyles and learn from others.
By Novel Allen6 days ago in Journal
Assessing DoorDash (DASH) Valuation After Recent Share Price Weakness and a Rich P/E Multiple
DoorDash (NASDAQ: DASH) has recently come under pressure, leaving investors wondering whether the pullback represents a buying opportunity or a warning sign. Despite reporting solid revenue growth and improving net income, the stock has declined 8.1% over the past week and 13.9% over the past month, adding to its year-to-date weakness.
By Omasanjuwa Ogharandukun6 days ago in Journal
Jordan Stolz Sets Olympic Record, Wins Gold in 1,000m at Milan Cortina Games
Milan, Italy (AP) — Jordan Stolz has imagined this moment since he was five years old. Back then, he was just a kid in Wisconsin, skating on a frozen backyard pond after watching the 2010 Winter Olympics and falling in love with speedskating. He dreamed of standing atop an Olympic podium one day.
By Omasanjuwa Ogharandukun6 days ago in Journal
James Anthony: A Life Fueled by Energy
My name is James Anthony, based in 100 Blvd Norman, Oklahoma and if there is one word that has defined my life, it is energy.
By Omasanjuwa Ogharandukun6 days ago in Journal
Smart Home Security Basics. AI-Generated.
Tonight I am writing from my living room while the house rests in a gentle silence. The clock on the wall moves steadily and the soft hum of the refrigerator fills the background. I never used to think much about safety beyond locking the door before bed. Lately though I have started to feel that security is not only about locks but about awareness and intention.
By Alex Bryn6 days ago in Journal
Moderna hit with FDA refusal-to-file letter for mRNA flu shot, issues sharp rebuke of agency's rationale. AI-Generated.
Moderna, a name synonymous with the success of mRNA technology during the COVID-19 pandemic, has been pushing hard to expand the reach of its platform into seasonal vaccines—especially influenza. With high expectations and ongoing global interest in the future of mRNA, the company was aiming to introduce one of the first-ever mRNA-based flu shots. But in a surprising twist, the U.S. Food and Drug Administration (FDA) issued Moderna a Refusal-to-File (RTF) letter, stopping the application before formal review could even begin. An RTF letter is not a common occurrence for a company of Moderna’s scale. The decision has sparked an industry-wide conversation: Is the FDA being overly cautious with emerging technologies, or did Moderna push its application prematurely? The sharp rebuttal from Moderna against the FDA’s rationale indicates that this is more than a procedural disagreement—it’s a clash over scientific standards and regulatory expectations. What Exactly Is an FDA Refusal-to-File Letter? Before diving into the controversy, it’s important to understand what an RTF letter means. When a company submits a Biologics License Application (BLA), the FDA conducts a preliminary assessment to determine whether the filing is complete enough for a full review. If critical information is missing or inadequate, the FDA issues a Refusal-to-File letter. In practical terms, an RTF letter means: The FDA will not begin the review process. The company must address deficiencies, add data, or correct documentation. Approval timelines can be delayed by months—or even years. For Moderna, this represents a significant setback. The company has been positioning itself as a leader in next-generation vaccines, and the mRNA flu shot is central to that vision. Having the FDA halt their application at the starting line suggests that regulators saw foundational gaps, not minor issues. Moderna Pushes Back: “The FDA’s Position Is Not Scientifically Justified” Moderna responded quickly and firmly to the FDA’s letter, expressing strong disagreement with the agency’s rationale. According to the company, the submitted data package: Met all necessary scientific standards, Contained sufficient safety and efficacy results from clinical trials, Was aligned with what Moderna believed the FDA had previously communicated. Their public statement criticized the FDA’s approach, calling it inconsistent and scientifically unfounded. Moderna emphasized that the clinical data gathered across multiple seasons and age groups clearly demonstrated their vaccine’s potential. This kind of direct pushback against the FDA is rare. It underscores how much is at stake—not only for Moderna’s product pipeline but for the broader acceptance of mRNA platforms in routine vaccinations. Why the FDA May Be Exercising Caution From the regulator’s perspective, the stakes are also high. Influenza vaccines are administered annually to millions of people, including vulnerable populations. The FDA may be holding mRNA flu vaccines to higher scrutiny because: mRNA-based flu shots are new territory for long-term seasonal use, The immune response to flu strains can be more variable than for COVID variants, Traditional flu vaccines rely on decades of safety and performance data, Influenza strains mutate unpredictably, requiring strong evidence of consistency. The FDA likely wants more assurance that an mRNA flu vaccine can be relied upon year after year. While Moderna believes it provided that evidence, the FDA appears to be requesting additional documentation, analysis, or clarity. The Stakes for Moderna: More Than Just a Delay This is not just a regulatory inconvenience—it's a critical moment for Moderna’s business model. The company has been working to reduce dependence on COVID-19 vaccine revenue by expanding into: Flu vaccines, RSV vaccines, Combination respiratory vaccines, Personalized cancer treatments. The flu vaccine market alone is worth billions annually. Missing even one flu season due to regulatory delays could significantly impact revenue projections and investor confidence. Moreover, Moderna is competing with Pfizer, Sanofi, and GSK, all of whom are also pursuing next-gen flu solutions. An FDA refusal gives competitors a window of opportunity. What This Means for the Future of mRNA in Seasonal Vaccination The dispute between Moderna and the FDA is bigger than a single vaccine. It raises broader questions about: 1. Regulatory standards for mRNA platforms COVID-19 showed the world what mRNA can accomplish under emergency use. But seasonal vaccines require long-term consistency and reliability. The FDA may be defining new expectations for mRNA-based annual shots. 2. The pace of innovation Pharma companies want to move quickly to market, especially with technologies that proved their value during the pandemic. Regulators, however, must balance innovation with patient safety. 3. Public perception Any regulatory drama involving vaccines—especially new technologies—can influence public trust. Both the FDA and Moderna understand how important transparency and scientific rigor are for maintaining confidence. What Happens Next? Moderna now has several options: Address the FDA’s concerns and resubmit the application, Provide additional clinical data from ongoing trials, Engage in further discussions with regulators to clarify expectations. The company has stated it will “work swiftly” to get the application back on track, though it has not yet provided a resubmission timeline. The upcoming flu season adds pressure—delays could push the vaccine launch further into the future. Conclusion: A Critical Crossroads for Moderna and mRNA Technology The FDA’s Refusal-to-File letter is a significant setback for Moderna, but it is not the end of the road. What’s unfolding is a defining moment in the evolution of mRNA technology. Will the regulatory environment adapt to support innovative platforms? Or will companies like Moderna need to adjust their strategies and timelines to meet stricter expectations? For now, the clash between Moderna and the FDA highlights an important reality: Even groundbreaking technologies must pass through the same rigorous scrutiny as every other medical product. The outcome of this confrontation will shape not only Moderna’s future, but the trajectory of mRNA vaccines for years to come.
By Abid Ali6 days ago in Journal
FDA Refuses to Review Moderna’s mRNA Flu Vaccine Application, Sparking Industry Uproar. AI-Generated.
The world of vaccines just witnessed an unexpected twist. Moderna, the biotech company famous for its COVID-19 mRNA vaccine, received a refusal-to-file (RTF) letter from the U.S. Food and Drug Administration (FDA) for its seasonal influenza mRNA vaccine, mRNA-1010. While this is not a safety rejection, the news sent ripples across the biotech and pharmaceutical industries—and even Wall Street. In this blog post, we break down what happened, why it matters, and what could come next.
By Ayesha Lashari6 days ago in Journal