Morning Glory Sciences– Author –
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Why Gene & Cell Therapies Stall at the FDA (2024–2025): What Recent CRLs Reveal about CMC, Inspections, and Trial Design
In July 2025, the FDA began publishing past Complete Response Letters (CRLs). Triangulating those releases with company disclosures and primary reporting shows two dominant themes: CMC (quality/manufacturing/testing) & Pre-License In... -
Beginner-Friendly｜Bispecific Antibody Drug Series Vol. 5: Latest Advances and 1-Year Approval Roundup
In this final volume, we summarize the latest developments in bispecific antibody drug R&D by leading biotech and pharma companies, as well as major approvals over the past year in the US and EU. We also highlight key trends and nota... -
Beginner-Friendly｜Bispecific Antibody Drug: Pharmacological Differences Based on Modalities Vol.4
Even among bispecific antibody drugs, the pharmacological behavior in the body can vary significantly depending on the structural modality. This article explains in simple terms how differences in modalities—such as IgG-based, non-IgG, a... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for HER2 TKD-Mutated NSCLC
On August 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamo... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Dordaviprone (Modeyso) for H3 K27M-Mutant Diffuse Midline Glioma
On August 6, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and pediatric patients (≥1 year) with progressive H3 K27M-mutant... -
Beginner-Friendly Series｜Bispecific Antibody Drug Vol.3：Strategic Considerations in Selecting Targets for Bispecific Antibody Drugs
In this third installment of our Beginner-Friendly Bispecific Antibody Drug series, we delve into the crucial question: “Which targets should be selected?” Target selection is a core strategic decision in bispecific antibody development,... -
[Beginner’s Guide to Bispecific Antibody Drugs] Vol.2 – Comparing Structural Designs and Their Impact on Therapeutic Efficacy
In this second installment of our series on bispecific antibody drugs, we delve into the diverse structural formats that define the field. From tandem scFvs to full-length IgG-like structures, we examine how these formats affect function... -
Beginner-Friendly｜What Are Bispecific Antibody Drugs? A Thorough Introduction (Part 1)
Introduction: Why Are Bispecific Antibody Drugs Gaining Attention? In recent years, bispecific antibody drugs (BsAbs) have garnered increasing attention in the treatment of cancer, autoimmune diseases, and infectious diseases. By binding... -
🧬 Unraveling Insulin Resistance and Type 2 Diabetes with Personalized Molecular Maps: The Power of Proteomics and Genomics
Why do some people develop diabetes while others with similar lifestyles don’t?The answer may lie in your molecular fingerprint. This article summarizes groundbreaking findings from a recent Cell (July 2025) paper and integrates insights... -
Arsenic Life and the Cost of Scientific Integrity: A 15-Year Retraction from Science
■ Introduction In July 2025, the prestigious journal Science officially retracted a paper it had published in 2010, claiming the discovery of a bacterium that could substitute arsenic for phosphorus in its DNA. Known as the “arsenic life... -
Pharma/Biotech News | Layoff Trends in the U.S. Biotech Sector 2025: Industry Reset or Prelude to a New Wave?
Fierce Biotech's "Layoff Tracker 2025" has captured a wave of downsizing across the U.S. biotech landscape in the first half of 2025. This article breaks down key layoffs, underlying causes, industry categories impacted, and what this mi... -
Beginner-Friendly in vivo CAR-T Series | Part 8
Global Strategies Shaping the Future of in vivo CAR-T Development Throughout this series, we have explored the cutting-edge developments of in vivo CAR-T therapy in an accessible way for beginners. In this final installment, we will exam... -
Beginner-Friendly in vivo CAR-T Series｜Part 7
Key Figures Shaping the Future of in vivo CAR-T This series aims to provide a clear and accessible overview of the latest advancements in in vivo CAR-T therapies, especially for beginners. In Part 7, we focus on the global researchers, e... -
[Beginner-Friendly In vivo CAR-T Series #6] Emerging Technologies Addressing In vivo CAR-T Challenges
In vivo CAR-T therapy has rapidly emerged as a promising next-generation cancer treatment. However, realizing its full potential requires overcoming several hurdles: targeting only the desired cells, ensuring safety, and maintaining sust... -
[Beginner-Friendly In Vivo CAR-T Series #5] Clinical Trial Frontlines and Emerging Biotechs
In previous installments, we've explored the fundamentals of CAR-T, the features of the in vivo model, gene delivery strategies, target antigens, and intracellular signaling. In this fifth edition, we shift our focus to clinical applicat... -
[Introductory In vivo CAR-T Series #4] Deep Dive into CAR Structure: The Latest in Co-stimulation and Signal Engineering
For in vivo CAR-T cells to attack cancer persistently and effectively, the structure of the CAR itself is critical. In particular, the design of co-stimulatory molecules and intracellular signaling domains directly impacts the treatment'... -
[Introductory In vivo CAR-T Series #3] Key to Precision and Safety: Designing Smart CAR Expression
In this third installment of our introductory series on in vivo CAR-T, we focus on a vital component for realizing safe and effective therapy: the design of CAR expression. We explore how “smart control” of CAR expression—targeting tumor... -
【Introductory In vivo CAR-T Series #2】The Technologies Behind In Vivo CAR-T: mRNA, Vectors, and Promoters
In the first installment of our series, we introduced the revolutionary CAR-T cell therapy through the moving story of Emily Whitehead. This time, we take a deep dive into the underlying technologies that make “in vivo CAR-T” possible. F... -
[Introductory In Vivo CAR-T Series #1] The Miracle of Emily: What Is CAR-T Therapy?
CAR-T cell therapy has emerged as a groundbreaking treatment that specifically targets cancer cells. Among its forms, the “in vivo type” CAR-T—where the therapeutic process happens inside the body—is gaining attention as a next-generatio... -
ADC Series – Bonus Chapter: Breakthroughs and the Fierce Global Race for Next-Generation Antibody-Drug Conjugates
Over the past few years, the landscape of Antibody-Drug Conjugates (ADCs) has undergone a dramatic transformation, shifting from a niche therapeutic approach to a central pillar of oncology innovation. This bonus chapter highlights recen...
