Sat.Mar 29, 2025 - Fri.Apr 04, 2025

article thumbnail

Researchers develop new DNA test for personalized treatment of bacterial vaginosis

Medical Xpress

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.

DNA 98
article thumbnail

April 2, 2025: The Greenlight Plus Trial and Preventing Childhood Obesity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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.

Trials 144
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Bio Pharma Dive

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

article thumbnail

Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers

Pharmaceutical Technology

The EC has approved Daiichi Sankyo and AstraZenecas Enhertu for use as a single agent to treat adults with certain breast cancers.

274
274
article thumbnail

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!

article thumbnail

Itolizumab Shows Positive Phase III Results in First-Line Treatment of Acute GVHD

XTalks

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.

article thumbnail

Researchers identify mutations that can lead to resistance to some chemotherapies

Medical Xpress

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.

More Trending

article thumbnail

Streeting promises UK pharma quick action on VPAG frustration

Pharmaceutical Technology

Streeting said his June 10-year plan will address drug sale clawbacks, NICE regulation, and the abolition of NHS England.

Sales 246
article thumbnail

AZmed’s AZchest Receives Two FDA Clearances for AI-Powered Software Applications

XTalks

European AI med tech company AZmed received two new FDA clearances for its AI-powered chest X-ray tool, AZchest. The FDA approved AZchest applications to detect lung nodules and triage cases involving pneumothorax and pleural effusion. The applications offer radiologists improved interpretation and detection of these chest X-ray abnormalities. AZchest, a clinically validated AI radiology solution, automatically identifies, classifies and generates reports on key cardiac and pulmonary abnormaliti

article thumbnail

Study reveals how Chagas parasite invades human cells

Medical Xpress

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.

article thumbnail

Roche halts testing of Sarepta Duchenne gene therapy in Europe

Bio Pharma Dive

The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.

article thumbnail

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

article thumbnail

Amneal and Shilpa introduce Boruzu in US for cancer treatment

Pharmaceutical Technology

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

234
234
article thumbnail

Sanofi’s Qfitlia Gets FDA Approval as First siRNA Therapy for Hemophilia

XTalks

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.

article thumbnail

AMMOI general secretary Dr Ramanathan elected as director board member of Ayushexcil

AuroBlog - Aurous Healthcare Clinical Trials blog

The Kerala based Ayurveda Medicine Manufacturers Organisation of India (AMMOI) has got a chair in the administrative committee of the Ayush Export Promotion Council (Ayushexcil ) with the election of its general secretary Dr. D Ramanathan as one of the board of directors.

article thumbnail

FDA official’s ouster sends shares of vaccine makers sliding

Bio Pharma Dive

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

article thumbnail

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

article thumbnail

Google-backed Isomorphic Labs raises $600m to advance AI drug discovery

Pharmaceutical Technology

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

Engineer 200
article thumbnail

Lilly’s Lepodisiran Achieves Over 90% Reduction in Heart Disease Marker in Phase II Trial

XTalks

Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. In the Phase II ALPACA trial, a single 400 mg dose of lepodisiran led to an average decrease of 93.9% in Lp(a) levels over the 60- to 180-day period after treatment compared to placebo, meeting the trials primary endpoint.

Trials 59
article thumbnail

The role of biosimilars in population health management initiatives

Drug Patent Watch

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?

article thumbnail

How discoverable, comparable and explorable is your data?

Bio Pharma Dive

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

Medicine 246
article thumbnail

The New Age of Decentralized Clinical Trials

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

article thumbnail

UK life sciences venture capital funding lags behind

Pharmaceutical Technology

At the BioTrinity Conference, experts champion government funding programmes to bridge gap the in UK venture capital financing.

article thumbnail

Scientists cast new light on how fasting impacts the immune system

Medical Xpress

New research from The University of Manchester may reshape our understanding of what happens to the immune system when we fast. The study on mice shows that the brain's hypothalamus controls how the immune system adapts during fasting, through a handful of highly specialized neurons responsible for making animals hungry.

Scientist 129
article thumbnail

Transforming Biopharma Intelligence: Moving from Traditional Analysts to Direct Raw Data Platforms

Drug Patent Watch

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.

article thumbnail

HHS begins layoffs in chaotic fashion

Bio Pharma Dive

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as cuts hit CDER.

219
219
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

Large pharma drug licensing from China hits high at 28% in 2024

Pharmaceutical Technology

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

Licensing 147
article thumbnail

New study reveals protector protein that supports hair regrowth in adults

Medical Xpress

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.

Protein 137
article thumbnail

Combating Autoimmunity: Vera Therapeutics CEO Dr. Marshall Fordyce Discusses Advancing IgAN Treatments — Episode 202

XTalks

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.

article thumbnail

‘A cruel April Fool’s joke’: HHS layoffs characterized by confusion, errors

Bio Pharma Dive

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

202
202
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Saving shelved ultra-rare therapies through unorthodox funding

Pharmaceutical Technology

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

Drugs 147
article thumbnail

How the brain uses context boundaries to guide decision-making in both spatial and abstract environments

Medical Xpress

The DAM-Decision and Memory group at Universitat Jaume I in Castell, led by Raphael Kaplan and composed of researchers from Spain, Italy and the United States, has recently published the results of two studies that provide new insights into human brain behavior in everyday activities such as decision-making and social interaction.

Research 122
article thumbnail

AI in Pharma Brand Planning: Insights from Our Latest Survey

Intouch Solutions

Artificial Intelligence (AI) is revolutionizing various industries, and pharma is no exception. However, despite its potential, more than half (55%) of pharma brand planning executives are concerned about their companys digital capabilities, especially generative AI. A recent article from Marketing & Pharma highlights the findings from EVERSANAs third-annual brand planning survey and the role AI plays in brand planning.

article thumbnail

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Bio Pharma Dive

Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a buyout and high-dose Ocrevus missed a study goal.

Trials 187
article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

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.