Sat.Jun 14, 2025 - Fri.Jun 20, 2025

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Morale at the FDA Has Hit Rock Bottom: What It Means for Pharma

World of DTC Marketing

Low morale within the Food and Drug Administration (FDA) is more than just an internal issue—it sends shockwaves through the pharmaceutical industry, affecting regulatory timelines, decision-making, innovation, and public trust. When morale within such a crucial organization dips significantly, pharma companies should brace for turbulence and prepare for strategic adjustments.

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Innovative Technique Allows In Vivo Creation of CAR T Cells for Cancer and Autoimmune Disease Treatment

Scienmag

In the rapidly evolving landscape of immunotherapy, researchers have unveiled a strikingly innovative approach that could revolutionize how chimeric antigen receptor (CAR) T cells are generated and deployed to combat cancer and autoimmune diseases. This novel strategy circumvents the traditional, labor-intensive ex vivo manufacturing processes by enabling the generation of CAR T cells directly within the patient’s body.

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STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results

STAT News

Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of them suffered severe bouts of low blood sugar. After 12 months, out of the 12 participants, 10 no longer needed to inject insulin.

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Grand Rounds June 13, 2025: Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials (Stephanie Morain, PhD, MPH; Nancy Kass, ScD; Ruth Faden, PhD, MPH)

Rethinking Clinical Trials

                        Speakers Stephanie Morain, PhD, MPH Associate Professor, Berman Institute of Bioethics & Department of Health Policy & Management Johns Hopkins University Nancy Kass, ScD Phoebe Berman Professor of Bioethics & Public Health Berman Institute of Bioethics & Department of Health Policy & Management Johns Hopkins University Ruth Faden, PhD, MPH Philip Franklin Wagley Professor of Biomedical Ethics Berman Institute of Bioethics &

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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.

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Vertex Reports Favorable Zimislecel Outcomes for Type 1 Diabetes at ADA Scientific Sessions

The Pharma Data

Vertex Showcases Groundbreaking Data for Zimislecel in Type 1 Diabetes at ADA 85th Scientific Sessions Vertex Pharmaceuticals Incorporated has announced compelling new clinical data from its ongoing FORWARD-101 trial, underscoring the transformative potential of its investigational islet cell therapy, zimislecel (VX-880), in patients with type 1 diabetes (T1D).

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National Heart Centre Singapore and Mayo Clinic Join Forces to Propel Cardiovascular Care and Research

Scienmag

In a landmark advancement for cardiovascular science and patient care, the National Heart Centre Singapore (NHCS) and the Mayo Clinic have formalized a strategic partnership through a Memorandum of Understanding (MOU) aimed at catalyzing breakthroughs in cardiovascular research and innovation. This unprecedented collaboration seeks to leverage deep clinical insights and cutting-edge technologies to reshape the future landscape of cardiovascular medicine, with a particular emphasis on Asian popul

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New development in stem cell transplant for blood cancers set to change 40 years of standard practice

Medical Xpress

Australian researchers have demonstrated that the use of a new, less toxic drug combination after stem cell transplants for leukemia significantly improves patient outcomes post-transplant, reducing the risk of the life-threatening complication of graft versus host disease (GVHD).

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EAACI: Dupixent Supersedes Xolair in CRS w/ Nasal Polyps and Asthma Phase 4 Head-to-Head Study

The Pharma Data

Sanofi and Regeneron’s Dupixent Shows Superiority over Xolair in First-Ever Head-to-Head Phase 4 Study in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps and Co-existing Asthma Sanofi and Regeneron Pharmaceuticals, Inc. today presented new and significant data demonstrating the superiority of Dupixent® (dupilumab) over Xolair® (omalizumab) in a first-of-its-kind, head-to-head, Phase 4 study in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and co-existing asth

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Millions of Nanoneedles Poised to Replace Painful Cancer Biopsies

Scienmag

A revolutionary innovation in medical diagnostics is on the horizon, poised to transform the way diseases such as cancer and neurodegenerative disorders are detected and monitored. Scientists at King’s College London have developed a groundbreaking nanoneedle patch, a device embedded with tens of millions of microscopic needles, each thousands of times thinner than a human hair.

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Launching the 2025 U.S. Clinical Trials Patient Survey

Velocity Clinical Research

At Velocity Clinical Research, we’re proud to be one of the largest clinical trial patient networks in the world, with access to over one million patients in our database across more than 70 integrated sites. That scale puts us in a unique position to listen, learn, and lead—and it’s why we’re excited to share insights from our latest nationwide patient survey.

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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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June 16, 2025: NIH Pragmatic Trials Collaboratory Holds Annual Steering Committee Meeting

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research. All materials from the meeting are now available online. The NIH Pragmatic Trials Collaboratory added 3 new trials in the past year.

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Phase 3 Trial of Ifinatamab Deruxtecan Begins in Advanced Prostate Cancer

The Pharma Data

Phase 3 Trial Launches for Ifinatamab Deruxtecan in Advanced Prostate Cancer Patients Daiichi Sankyo and Merck have announced the initiation of IDeate-Prostate01 , a global Phase 3 clinical trial evaluating the investigational drug ifinatamab deruxtecan (I-DXd) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression during or following treatment with androgen receptor pathway inhibitors (ARPIs).

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Innovative Nanoparticles Enable Safer, More Efficient Drug Delivery

Scienmag

In a groundbreaking advancement that promises to reshape the landscape of targeted drug delivery, scientists at Xi’an Jiaotong-Liverpool University (XJTLU) in collaboration with Nanjing University have engineered a novel nanoparticle system that significantly enhances the efficiency and safety of administering chemotherapy and potentially other therapeutic agents.

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HIV prevention drug hailed as a 'breakthrough' gets FDA approval

NPR Health - Shots

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?

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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!

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Discovery of DIAL syndrome links faulty DNA repair to childhood cancer risk and chemo sensitivity

Medical Xpress

A new hereditary condition has been discovered that affects patients' ability to repair DNA—leaving them both at greater risk of developing blood cancer, and unable to repair some of the damage caused by chemotherapy treatments.

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Genmab: Epcoritamab Combo Shows High Response in Transplant-Eligible R/R DLBCL

The Pharma Data

Genmab Presents Positive Epcoritamab Combination Data in Relapsed or Refractory DLBCL Eligible for Autologous Stem Cell Transplantation Genmab A/S today shared new and highly promising data from its Phase 1b/2 EPCORE® NHL-2 trial (Arm 10, NCT04663347) evaluating its T-cell-engaging bispecific antibody, epcoritamab, in combination with rituximab, ifosfamide, carboplatin, and etoposide — a regimen collectively known as R-ICE — in adult patients with relapsed or refractory (R/R) diffuse large B-cel

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Unlocking Epigenetic Secrets of Newborn Pulmonary Hypertension

Scienmag

In a groundbreaking new study published in Pediatric Research , scientists have unlocked critical insights into the epigenetic regulation of Notch signaling pathways in persistent pulmonary hypertension of the newborn (PPHN), a devastating and often fatal condition affecting the pulmonary vasculature of neonates. This research profoundly deepens our understanding of the molecular choreography that governs disease progression and opens innovative avenues for targeted therapeutic interventions.

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FDA approves twice-yearly shot of Gilead drug for HIV prevention

Bio Pharma Dive

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.

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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

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Surprising drug combination cuts alcohol use and lessens nausea in clinical trial

Medical Xpress

Two existing medications—one used for smoking cessation and the other for depression—appear to work effectively together in treating alcohol use disorder. The combination reduces alcohol cravings, lowers consumption, and may decrease the risk of nausea. These findings come from a new study led by the University of Gothenburg, Sweden.

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Sarepta Strengthens ELEVIDYS Safety Measures for Non-Ambulatory Duchenne Patients

The Pharma Data

Sarepta Takes Action to Strengthen ELEVIDYS Safety Measures in Non-Ambulatory Duchenne Patients Sarepta Therapeutic a leading innovator in precision genetic medicine for rare disorders, today provided a significant safety update for ELEVIDYS (delandistrogene moxeparvovec-rokl). ELEVIDYS is currently the only U.S. Food and Drug Administration (FDA)-approved gene therapy for the treatment of Duchenne muscular dystrophy (DMD).

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Professor Marco Durante Awarded Prestigious ERC Grant: EU Commits Millions to GSI Tumor Therapy Research Exploring the FLASH Effect

Scienmag

Professor Marco Durante, a leading figure in the field of biophysics and heavy-ion therapy, has been honored with the European Research Council’s prestigious Advanced Grant. This award, designated for established scientists conducting groundbreaking research, will provide Professor Durante with multi-million euro funding to propel his ambitious project aimed at revolutionizing tumor therapy.

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FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

FDA Law

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

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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?

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Opinion: Six former CDC vaccine advisory committee chairs warn: U.S. risks losing access to life-saving immunizations

STAT News

As former chairs of the CDC’s Advisory Committee on Immunization Practices ( ACIP ), we are deeply alarmed by the growing politicization of vaccines — a public health innovation that has saved 154 million lives globally. While politicization of science is not new, the escalating distrust in science across the political spectrum, and its intrusion into the vaccine ecosystem, now threatens the very infrastructure that has long protected Americans from infectious diseases.

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Merck Names Neoclease Winner of 2025 Biotech Grant

The Pharma Data

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.

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Stanford Researchers Identify Missing Yew Tree Enzymes Crucial for Producing Common Cancer Drug

Scienmag

A Breakthrough in Taxol Biosynthesis: Unlocking the Enzymatic Blueprint for Scalable Cancer Drug Production Taxol, also known as paclitaxel, has stood as a cornerstone chemotherapy agent for decades, revolutionizing treatments for ovarian, breast, and lung cancers worldwide. Despite its critical role in oncology, the current approach to Taxol production faces substantial limitations.

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Screen addiction and suicidal behaviors are linked for teens, a study shows

NPR Health - Shots

The study, published in JAMA, followed teens for years and evaluated addictive behaviors, as well as suicidality.

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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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Draig secures $140m for neuropsychiatric disorder therapies

Pharmaceutical Technology

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Alnylam Promotes Pushkal Garg to Chief R&D Officer

The Pharma Data

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.

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Elevated Cancer Burden Linked to Increased Racial Diversity and Environmental Stress in Neighborhoods

Scienmag

A recent breakthrough cohort study published in JAMA Network Open has revealed critical insights into the intricate relationship between environmental burden and cancer incidence rates across diverse racial and ethnic populations. This comprehensive investigation emphasizes the pressing need for sustained and targeted community interventions, particularly in minoritized census regions characterized by elevated environmental stressors.

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Ibtrozi Wins FDA Approval for ROS1+ NSCLC, Set to Challenge Reigning TKIs Xalkori, Augtyro and Rozlytrek

XTalks

The FDA has approved Ibtrozi (taletrectinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Developed by Nuvation Bio, taletrectinib is a next-generation oral tyrosine kinase inhibitor (TKI) designed to target cancers driven by ROS1 gene fusions. The fusions are more common in younger patients and those who have never smoked, and are frequently associated with brain metastases.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model