Bio Pharma Dive

MARCH 31, 2025

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

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Gene Therapy Gene Regulation 296

Rethinking Clinical Trials

APRIL 2, 2025

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K.

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Trials Clinical Trials Clinical Trials Medicine 130

Bio Pharma Dive

MARCH 27, 2025

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not be affected.

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Drugs 327

Medical Xpress

MARCH 29, 2025

Roughly one out of three women ages 14-49 in the United States develop a vaginal bacterial imbalance known as bacterial vaginosis (BV) during their lifetime. BV is characterized by unpleasant odors, and potentially painful side effects, as well as the risk of associated health issues later in life. More than half of the patients who seek medical care do not respond to the first-line treatment, the antibiotic metronidazole, leading to recurrence.

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DNA Development Research Genetics 120

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!

Clinical Trials

Pharmaceutical Technology

MARCH 27, 2025

GLP-1RAs were the big game changer, boosting average forecast sales and return on investment rates.

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Sales Drugs 246

XTalks

APRIL 1, 2025

Equillium announced encouraging topline results from its Phase III EQUATOR study evaluating itolizumab in combination with corticosteroids as a first-line treatment for patients with acute graft-versus-host disease (aGVHD). The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD.

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Immune Response Trials Licensing Licensing 59

Drug Patent Watch

APRIL 2, 2025

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?

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Production Manufacturing Development Medicine 52

Medical Xpress

MARCH 29, 2025

Investigators at Mass General Brigham have uncovered how resistance to chemotherapies may occur in some cancers. Researchers focused on a pathway that harnesses reactive oxygen species (ROS) to kill cancer cells. The study found that mutations to VPS35, a key player in this pathway, can prevent chemotherapy-induced cell death. These results, published in Nature, could help pinpoint treatment-resistant tumors.

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Research Genetics 115

Pharmaceutical Technology

MARCH 28, 2025

The Macau Special Administrative Region (ISAF) Pharmaceutical Administration Bureau has approved IASO Bio's NDA for equecabtagene autoleucel.

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XTalks

APRIL 1, 2025

The FDA has approved Sanofis Qfitlia (fitusiran), making it the first approved siRNA therapy for hemophilia A or B, and the first for the conditions with or without inhibitors. It is indicated to prevent or reduce bleeding episodes in patients aged 12 and older, with or without factor VIII or IX inhibitors. Qfitlia is also the first antithrombin-lowering therapy approved for routine prophylaxis in hemophilia A or B.

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FDA Approval RNA Clinical Trials Clinical Trials 52

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

Medicine

Drug Patent Watch

APRIL 2, 2025

The Future of Biopharma Intelligence: Why Direct Data Platforms are Revolutionizing the Industry As a biopharma professional, you're likely no stranger to the challenges of staying ahead in a rapidly evolving market. From navigating complex regulatory landscapes to keeping pace with the latest scientific breakthroughs, it's easy to get overwhelmed by the sheer volume of information at your fingertips.

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Clinical Trials Clinical Trials Marketing Trials 52

Medical Xpress

MARCH 28, 2025

According to a recent study from the University of Jyvskyl, Finland, the impacts of everyday physical activity do not attenuate the accelerated hormonal bone loss that occurs during menopause. Effective bone-loading impacts are rare in everyday life. Future research should explore whether more targeted exercise can slow menopausal bone loss. The study suggests that impacts accumulated during everyday life are not sufficient to slow hormonal bone loss during menopause.

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Hormones Research Gerontology 75

Pharmaceutical Technology

MARCH 31, 2025

The funding is set to accelerate the development of Isomorphics AI drug design engine and advance clinical programmes.

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Engineer Drugs Development 200

Drug Channels

APRIL 2, 2025

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from December 2024. Its time to pay attention to the money behind the 340B curtain. Minnesota just released the industrys first ever mandated financial report on the 340B Drug Pricing Program.

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Pharmacy Drugs 52

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Clinical Supply

Bio Pharma Dive

MARCH 28, 2025

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

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Regulation Marketing 287

XTalks

APRIL 2, 2025

In this episode, Ayesha spoke with Marshall Fordyce, MD, founder and CEO of Vera Therapeutics , a company focused on developing treatments for autoimmune diseases. Dr. Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a successful Phase II trial in IgA nephropathy.

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Life Science Clinical Development Development Trials 52

Medical Xpress

MARCH 29, 2025

Researchers from Auburn University, in a landmark collaboration with Brazil's Oswaldo Cruz Foundation (FIOCRUZ), the world's leading research institution on Chagas Disease, have published a significant study in the journal Biochemistry. The study sheds new light on how the Chagas Disease parasite invades human cellsa crucial step towards developing effective treatments for this neglected tropical disease.

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Research Development 73

Pharmaceutical Technology

APRIL 2, 2025

Amneal Pharmaceuticals, along with Shilpa Medicare, has launched the new presentation of bortezomib, Boruzu.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharma Times

MARCH 27, 2025

Janssen drug combination extends life expectancy during trial

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Trials Drugs 103

Bio Pharma Dive

MARCH 31, 2025

Accelerate biomarker research with high-quality, expert-curated data to drive precision medicine.

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Medicine Research 246

pharmaphorum

MARCH 31, 2025

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug

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Drugs 98

Medical Xpress

MARCH 28, 2025

In what is believed to be a world-first study, researchers from the University of Adelaide's Australian Dysautonomia and Arrhythmia Research Collaborative (ADARC) have used brain scans to identify blood flow problems in people with postural orthostatic tachycardia syndrome (POTS).

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Research 145

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Pharmaceutical Technology

APRIL 1, 2025

Total deal value of innovator drug licensing agreements involving Chinese biopharma licensors has risen 66% to $41.5 billion in 2024.

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Licensing Licensing Drugs 147

Pharma Times

APRIL 2, 2025

Advancing care for stage 3 or 4 Hodgkin lymphoma patients

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Bio Pharma Dive

MARCH 28, 2025

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients who are eligible for treatment.

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Drugs 239

pharmaphorum

MARCH 27, 2025

Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for excessive eating in rare disorder Prader-Willi syndrome.

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FDA Approval 94

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Medical Xpress

MARCH 29, 2025

Alopecia is an autoimmune disorder that causes non-scarring hair loss on the scalp and body that is experienced by almost 2% of the global population at some point in their lifetime.

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Protein Genetics 141

Pharmaceutical Technology

MARCH 31, 2025

Non-profit organisations provide an alternative to rescue stalled orphan drugs for biotechs struggling against a lethargic investment climate.

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Drugs 147

JAMA Internal Medicine

MARCH 27, 2025

This Viewpoint discusses the critical importance of continued funding for the intramural research program in the Department of Veterans Affairs.

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Research 89

Bio Pharma Dive

MARCH 31, 2025

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

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Vaccination Vaccine 236

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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