FDA approves twice-yearly shot of Gilead drug for HIV prevention
Bio Pharma Dive
JUNE 18, 2025
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
Wed.Jun 18, 2025
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June 18, 2025: The BedMed and BedMed-Frail Trials, in This Week’s Rethinking Clinical Trials Grand Rounds
Rethinking Clinical Trials
JUNE 18, 2025
Dr. Scott Garrison In this Friday’s Rethinking Clinical Trials Grand Rounds, Scott Garrison of the University of Alberta will present “The BedMed and BedMed-Frail Randomized Trials.” The trials compared bedtime vs morning administration of antihypertensive medications. The live webinar will be held on Friday, June 20, 2025, at 1:00 pm eastern.
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FDA to speed reviews for drugs supporting ‘national interests’
Bio Pharma Dive
JUNE 18, 2025
A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
In Vivo Mapping of Human Enhancer Mutagenesis
Scienmag
JUNE 18, 2025
In a groundbreaking new study, scientists have unveiled a comprehensive map detailing the mutagenesis sensitivity of human developmental enhancers in vivo, shedding unprecedented light on the intricate sequence architecture that governs gene regulation during human development. Enhancers, which are distal DNA elements, play a pivotal role in orchestrating the precise spatial and temporal expression of genes essential for embryogenesis.
How to Turn “Check-the-Box” Compliance Trainings Into Real Learning
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
When a New Drug Fails at Launch: Who’s Most to Blame?
World of DTC Marketing
JUNE 18, 2025
Bringing a new drug to market is a high-stakes game. After years of research, clinical trials, regulatory hurdles, and millions—if not billions—of dollars invested, launch day is supposed to mark the beginning of commercial success. Yet, many drugs fail to meet expectations out of the gate. When that happens, finger-pointing begins. But who bears the blame when a new drug flops at launch?
UT Health San Antonio Scientists Uncover Key Mechanisms Behind Cancer Drug Resistance
Scienmag
JUNE 18, 2025
Researchers Uncover Key Mechanism Behind PARP Inhibitor Resistance in BRCA1-Deficient Cancers In a groundbreaking discovery poised to transform cancer therapy, scientists have identified a crucial protein complex that influences resistance to PARP inhibitors in cancers harboring BRCA1 mutations. Approximately one in every 300 Americans carries mutations in BRCA1 or BRCA2, genes seminal to DNA repair mechanisms, predisposing them to higher risks of breast, ovarian, and prostate cancers.
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Cost-Effective Genetic Testing Advances Early Detection of Prostate Cancer
Scienmag
JUNE 18, 2025
A groundbreaking study led by Pankaja B. Umarane and her colleagues at KLES Dr. Prabhakar Kore Hospital and MRC, in collaboration with KLE Academy of Higher Education and Research (Deemed-to-be-University), has revealed promising advancements in the early detection of prostate cancer through integrating molecular diagnostic tools. Prostate cancer remains one of the most frequently diagnosed malignancies among men globally, posing significant challenges due to its heterogeneity and diagnostic com
HIV prevention drug hailed as a 'breakthrough' gets FDA approval
NPR Health - Shots
JUNE 18, 2025
A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. One looming question: Will it be affordable for lower resource countries?
Heat Shock Proteins Signal Neuron-Glia Aging Talk
Scienmag
JUNE 18, 2025
In the intricate world of neuroscience, the symbiotic relationship between neurons and glial cells forms the foundation of brain function and resilience. While these cell types have long been recognized for their individual roles within the nervous system, recent research unveils a provocative new avenue for understanding how these cellular partnerships evolve, especially in the context of aging.
Merck Names Neoclease Winner of 2025 Biotech Grant
The Pharma Data
JUNE 18, 2025
Merck Awards 2025 North American Advance Biotech Grant to Neoclease for AI-Driven Parkinson’s Gene Editing Therapy Merck, a global leader in science and technology, has officially named Neoclease as the recipient of its 2025 North American Advance Biotech Grant , recognizing the Boston-based biotech startup for its cutting-edge work in AI-designed gene-editing therapies, particularly targeting Parkinson’s disease.
Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Decoding Epigenetic Triggers: Unveiling the Mechanisms Driving Hepatocellular Carcinoma
Scienmag
JUNE 18, 2025
Hepatocellular carcinoma (HCC), the predominant form of primary liver cancer, persists as a formidable global health challenge due to its high incidence and mortality rates. While traditionally linked to environmental risk factors such as hepatitis virus infections and chronic alcohol use, mounting evidence implicates epigenetic dysregulation as a pivotal mechanism driving hepatocarcinogenesis.
Alnylam Promotes Pushkal Garg to Chief R&D Officer
The Pharma Data
JUNE 18, 2025
Alnylam Elevates Dr. Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D., to the role of Executive Vice President and Chief Research and Development Officer.
Scientists Reveal Unexpected Role of ‘Natural Killer’ Cells in Cancer Immunotherapy Resistance
Scienmag
JUNE 18, 2025
In a groundbreaking study poised to reshape the landscape of cancer immunotherapy, researchers at the VIB-KU Leuven Center for Cancer Biology have unveiled a paradoxical role of ‘natural killer’ (NK) cells in melanoma patients resistant to immune checkpoint blockade (ICB) therapies. Traditionally celebrated as potent cytotoxic agents targeting tumor cells, these NK cells may, under certain circumstances, hinder the immune system’s assault on malignancies.
FDA’s New Priority Voucher Pilot Program Has Landed: CNPV
FDA Law
JUNE 18, 2025
By Mark A. Tobolowsky & Michelle L. Butler & Deborah L. Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. As described in the press release and accompanying FAQ , the CNPV program is designed to reduce review time to 1-2 months following final drug applicati
Can Your Organization Spot a Conflict Before It’s a Crisis?
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
Breakthrough Supercharged Vaccine Promises Strong Protection with a Single Dose
Scienmag
JUNE 18, 2025
Researchers at MIT and the Scripps Research Institute have unveiled a groundbreaking vaccine approach that may revolutionize the way we combat persistent infectious diseases such as HIV and SARS-CoV-2. By harnessing a synergistic combination of two powerful adjuvants within a single vaccine dose, this method elicits a dramatically enhanced immune response, notably broadening the diversity and potency of antibodies produced.
Screen addiction and suicidal behaviors are linked for teens, a study shows
NPR Health - Shots
JUNE 18, 2025
The study, published in JAMA, followed teens for years and evaluated addictive behaviors, as well as suicidality.
Gut Inflammation Triggers Neuroinflammation via CD4 Cells
Scienmag
JUNE 18, 2025
In recent years, the intricate relationship between the gut microbiota and systemic health has become a focal point of biomedical research, linking microbial communities to a diverse spectrum of diseases. Although the gut microbiome is well-established as a pivotal player in conditions ranging from inflammatory bowel disease to neurodegenerative disorders, the precise mechanisms by which these microorganisms influence inflammation beyond the gastrointestinal tract remain largely elusive.
Biogen Launches Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia
The Pharma Data
JUNE 18, 2025
Biogen Launches Global Phase 3 Pediatric Trial of Omaveloxolone for Friedreich Ataxia Biogen has officially launched its BRAVE study a pivotal, global Phase 3 clinical trial aimed at evaluating omaveloxolone in pediatric patients with Friedreich ataxia (FA). This significant development marks a critical step in extending treatment to a younger population suffering from this rare and progressive neuromuscular disorder.
White Paper - A Roadmap to AI Data Readiness in R&D Labs
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Community-Based Mentoring in Sierra Leone Doubles Survival Rates for Pregnant Adolescents and Their Babies
Scienmag
JUNE 18, 2025
A groundbreaking community-based mentoring initiative tailored for pregnant adolescent girls in Sierra Leone has demonstrated remarkable success in saving lives and enabling young mothers to resume their education and vocational pursuits. This innovative program, known as 2YoungLives, was recently evaluated in a pilot trial that revealed a dramatic reduction in combined maternal and perinatal mortality rates.
Genomics to roll out predictive clinical test across UK
Pharmaceutical Technology
JUNE 18, 2025
Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh
Pandora’s Microbes: Unraveling the Lung’s Iron War
Scienmag
JUNE 18, 2025
In the intricate and competitive environment of the human body, bacteria of the genus Pandoraea have long remained an enigma to scientists. These microorganisms, named evocatively after Pandora’s box from Greek mythology—a symbol of hidden and uncontrollable dangers—pose a significant health risk due to their pathogenic nature and antibiotic resistance.
AbbVie: Atogepant Outperforms Topiramate in Phase 3 Migraine Study
The Pharma Data
JUNE 18, 2025
AbbVie Reports Strong Phase 3 Results for Atogepant, Demonstrating Superiority Over Topiramate in Migraine Prevention AbbVie , a leading global biopharmaceutical company, has announced promising topline results from its pivotal Phase 3 TEMPLE clinical trial—a multicenter, randomized, double-blind, head-to-head study that evaluated the efficacy, safety, and tolerability of atogepant (branded as QULIPTA® in the U.S. and AQUIPTA® in the EU) compared to topiramate, a widely used anticonvulsant appro
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
White Matter Changes Linked to Early Psychosis Signs
Scienmag
JUNE 18, 2025
In a groundbreaking study published in Schizophrenia (2025), researchers Chen, Bo, Zhao, and colleagues have unveiled critical insights into the white matter alterations within the frontal–striatal–thalamic circuit of individuals exhibiting attenuated positive symptom syndromes (APSS). This intricate neural pathway, which anchors fundamental cognitive and emotional processes, appears to show specific abnormalities potentially linked to prodromal psychotic experiences.
STAT+: Gilead won U.S. approval for HIV prevention shot, but when will low-income countries gain sufficient access?
STAT News
JUNE 18, 2025
Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug , the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem. As far as Gilead is concerned, the groundwork exists to meet that goal. Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries.
Optimistic Mindset Linked to Reduced Memory Decline in Middle Age, 16-Year Study Finds
Scienmag
JUNE 18, 2025
New research published in the journal Aging & Mental Health provides compelling evidence that higher levels of psychological wellbeing may play a protective role against memory decline in middle-aged and older adults. Over a 16-year longitudinal study involving more than 10,000 individuals aged 50 and above, scientists have observed a significant association between self-reported wellbeing and subsequent memory performance.
A startup banks $66M to pursue ‘inclusive precision medicine’
Bio Pharma Dive
JUNE 18, 2025
With backers such as Regeneron’s venture arm, Actio Biosciences is working on medicines that counter a wide range of disease-causing genetic mutations in conditions like epilepsy and Charcot-Marie-Tooth disease.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Hospital Drug Shortages Cost $900M in Labor According to Vizient Survey
XTalks
JUNE 18, 2025
Hospitals across the US spent over 20 million hours in 2023 managing drug shortages — costing nearly $900 million in labor expenses, according to Vizient’s 2024 Drug Shortages Survey. The problem, once seen as sporadic, has now become a structural burden across hospital systems. Conducted from April to September 2024, the survey collected data from 132 Vizient hospitals in 2023.
Tisento’s MELAS treatment receives fast track status from FDA
Pharmaceutical Technology
JUNE 18, 2025
Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh
Compact Quantum Magnetometer Unlocks New Measurement Opportunities Across Diverse Applications
Scienmag
JUNE 18, 2025
The latest developments in quantum sensing technology are not just theoretical concepts confined to laboratories; they herald a transformative potential across various domains, particularly in biomedicine, navigation, and geology. The Fraunhofer Institute for Applied Solid State Physics (IAF) has designed a highly integrated vector magnetometer that utilizes nitrogen vacancies (NV) in diamond, enabling unprecedented exploration and utilization of magnetic fields.
HIV protection with just two shots a year: FDA approves Gilead drug
STAT News
JUNE 18, 2025
The Food and Drug Administration approved Wednesday a powerful new drug that provides nearly complete protection against HIV infection with just a single administration every six months. The injection, known chemically as lenacapavir and to be marketed as Yeztugo, has been hailed as the closest thing the field has ever had to a vaccine — a groundbreaking intervention that, if rolled out properly, could bring a 45-year-old pandemic to heel.
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