FDA, Clinical Trials, Public Safety Corey Hubbard FDA, Clinical Trials, Public Safety Corey Hubbard

Clinical Trial Safety and Financial Turmoil: The CytomX Case Study

Clinical trials represent a crucial stage in bringing new medicines to patients, but they are inherently complex and carry significant risks, particularly in the early phases where safety is the primary focus. These investigations often involve patients dealing with serious illnesses, such as cancer, where standard treatments may no longer be effective

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Clinical Trials, Therapuetics, FDA, Patients Corey Hubbard Clinical Trials, Therapuetics, FDA, Patients Corey Hubbard

Phase I Clinical Trials: Participant Insights, Systemic Pressures, and Safety-First Protocols

Dive into the complex world of Phase I clinical trials, where healthy volunteers test new drugs for safety in exchange for financial compensation. Discover the unspoken dynamics and perverse incentives that lead participants to strategically manage disclosures and navigate strict exclusion criteria to maintain eligibility and maximize their income. Understand the prevalent "better safe than sorry" atmosphere that shapes this challenging research environment and influences participant behavior.

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Clinical Trials, FDA, NIA, Caregiving Corey Hubbard Clinical Trials, FDA, NIA, Caregiving Corey Hubbard

Unlock the Alzheimer's Enigma: Science, Struggle, and the Art of Connection

The human brain, an astonishing network of 85 billion nerve cells, stands as the control tower of our existence, orchestrating every thought, emotion, and movement. It remains a "final frontier" for scientific exploration, much like the deepest oceans or distant galaxies, holding secrets that promise to revolutionize medicine

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Clinical Trials, Therapuetics, FDA Corey Hubbard Clinical Trials, Therapuetics, FDA Corey Hubbard

Lantern Pharma Completes Japan Enrollment for Phase II LP-300 NSCLC Trial Ahead of Schedule

Lantern Pharma has successfully completed targeted patient enrollment in Japan ahead of schedule for its multi-centre Phase II HARMONIC clinical trial of LP-300. This trial evaluates the safety and efficacy of LP-300, a disulfide small molecule, alongside standard-of-care chemotherapy for never-smoker NSCLC patients who have relapsed after TKI treatment

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Brain Breakthrough: Oragenics and Southern Star Pioneer New Hope for Concussion Treatment

In a significant stride towards addressing a pressing global health challenge, Oragenics, a leading name in pharmaceutical innovation, has officially joined forces with Southern Star Research, an Australia-based clinical research organisation (CRO), to kickstart a crucial Phase IIa trial for its groundbreaking concussion drug candidate, ONP-002

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Clinical Trials, Therapuetics, FDA Corey Hubbard Clinical Trials, Therapuetics, FDA Corey Hubbard

Unlocking Myasthenia Gravis Efficacy: Navigating Advanced Outcome Measures in Clinical Trials

Delve into the complexities of Myasthenia Gravis (MG), a heterogeneous neuromuscular disorder, and explore the evolution of standardized clinical scales and questionnaires used as outcome measures in clinical trials. Understand the shift from objective assessments to patient-reported outcomes (PROs), including key scales like QMG, MG-ADL, MGC, and QOL15(r)

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Clinical Trials, Therapuetics, FDA Corey Hubbard Clinical Trials, Therapuetics, FDA Corey Hubbard

Igniting Hope: 360° Recruitment & Digital Breakthroughs Accelerate Alzheimer's Trials!

The future of Alzheimer's disease research is brighter than ever! Discover how groundbreaking strategies, including innovative blood-based biomarker tests, virtual clinical trials, and culturally-informed community engagement, are dramatically increasing diverse participation and accelerating the development of urgently needed AD therapies

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Clinical Trials, FDA, Medical Researchers Corey Hubbard Clinical Trials, FDA, Medical Researchers Corey Hubbard

EyePoint's Duravyu: Advancing Wet AMD Treatment with Completed Phase III & Sustained Delivery Breakthroughs

EyePoint Pharmaceuticals has successfully concluded Phase III enrollment for Duravyu (EYP-1901), a groundbreaking sustained-release therapy for wet Age-related Macular Degeneration (wet AMD). With over 400 subjects across the pivotal LUCIA and LUGANO trials

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Clinical Trials, Innovation, FDA Corey Hubbard Clinical Trials, Innovation, FDA Corey Hubbard

Viatris' Blepharitis Ointment Fails Phase III: Full Disclosure on Clinical Setback & Its Future

Breaking News: Get the full, transparent details on why Viatris's investigational MR-139 (pimecrolimus 0.3%) ophthalmic ointment for blepharitis failed its Phase III trial. Discover how the therapy did not meet its primary endpoint of complete resolution of debris after six weeks of twice-daily dosing.

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AI Flips Eroom's Law: Supercharging Clinical Trial Success & Slaying Billion-Dollar Failures!

Tired of clinical trials sinking $800 million to $1.4 billion and taking 10-15 years to bring a single new drug to market, with high failure rates contributing significantly to inefficiency? Discover how Artificial Intelligence (AI) is revolutionizing drug development, tackling main causes of failure like suboptimal patient selection, recruiting, and monitoring

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Therapuetics, Clinical Trials, Innovation Corey Hubbard Therapuetics, Clinical Trials, Innovation Corey Hubbard

Igniting Hope: AstraZeneca & Modella AI Forge Game-Changing Partnership to Revolutionize Cancer Clinical Development!

Get ready for a paradigm shift in oncology! AstraZeneca and Modella AI have officially launched a groundbreaking, multi-year agreement to supercharge AI-driven cancer clinical development worldwide. This exciting collaboration grants AstraZeneca unparalleled access to Modella AI's cutting-edge, multi-modal foundation models, designed to extract rich features from diverse data types and accelerate every aspect of clinical development across their global oncology portfolio. Witness the future of medicine as this partnership aims to enhance biomarker discovery, streamline clinical development, and ultimately transform patient outcomes. With AI deeply integrated into their strategy, AstraZeneca is confident in increasing the probabilities of success in their oncology clinical trials. This isn't just an agreement; it's a powerful leap forward for precision medicine, promising unprecedented speed and the potential to automate complex R&D workflows for a brighter, healthier future!

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Sodium Channel Blockers: The Non-Opioid Pain Revolution After Vertex's Journavx

Discover how Vertex Pharmaceuticals' Journavx approval marks a "watershed moment" for pain relief, ushering in a new era of non-opioid sodium channel blockers. Learn about biotechs targeting NaV1.8 and NaV1.7 to stop pain signals at the source, offering safer, non-addictive alternatives to conventional opioids. Explore the companies and the science driving this significant investment in the future of pain management.

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Clinical Trials, Therapuetics, FDA Corey Hubbard Clinical Trials, Therapuetics, FDA Corey Hubbard

BioAtla's BA3182 Shows Promising Safety and Anti-Tumour Activity in Metastatic Adenocarcinoma

Discover encouraging results from BioAtla's Phase I trial of BA3182 for heavily pretreated metastatic adenocarcinoma. This innovative dual-conditionally active biologic (CAB) therapy, designed to minimize off-target toxicities, has demonstrated a reassuring safety profile with predominantly low-grade and manageable adverse events. The study has observed objective tumour size decreases in five subjects across various cancer types, including two colorectal carcinoma subjects with impressive progression-free intervals of 11 and 14 months. With ongoing dose escalation, updated Phase I data are anticipated later this year, highlighting the potential of BA3182 as a new treatment option.

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Clinical Trials, AI, Healthcare Corey Hubbard Clinical Trials, AI, Healthcare Corey Hubbard

Ethical Excellence: Inclusivity & AI in Clinical Research

Embark on a comprehensive exploration into the dynamic landscape of ethical standards in clinical research, charting its evolution from lessons learned through historical breaches to the complex frontiers of artificial intelligence and imperative for inclusivity. This detailed overview underscores how foundational principles forged in response to past ethical violations are now critically applied to modern challenges, ensuring "smart science is smart business" while prioritizing patient safety and trust.

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