Sat.Jan 04, 2025 - Fri.Jan 10, 2025

article thumbnail

Open-World Games Like Zelda Can Boost Your Mental Health, Study Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Still from Breath of the Wild. (Nintendo) Many modern video games fall into the open-world category, giving players vast, detailed worlds to explore and a new study shows these expansive digital playgrounds have benefits for our mental health.

Research 246
article thumbnail

FDA adds warning to RSV shots from GSK, Pfizer

Bio Pharma Dive

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA CDER director Patrizia Cavazzoni announces resignation

Pharmaceutical Technology

Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.

278
278
article thumbnail

Adaptive Trial Designs in Cardiovascular Metabolism Studies

Worldwide Clinical Trials

With 20-25% of the global population affected by metabolic problems, finding effective treatments is crucial for cardiovascular and metabolic (CVM) conditions. Traditional study designs feature predetermined sample sizes, assessments, and analyses that must remain in place over long treatment durations. Although formal protocol amendments are possible, this process is time-consuming and complex.

Trials 189
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

Artificial intelligence and machine learning transforming ICU decision-making: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

Artificial intelligence (AI) and machine learning (ML) are poised to redefine the landscape of critical care medicine, offering innovative solutions to the challenges faced in intensive care units (ICUs). ICUs are high-stakes environments where every decision can mean the difference between life and death.

Medicine 244
article thumbnail

ALS drugs from Denali, Calico come up short, marking more failures for Healey trial

Bio Pharma Dive

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

More Trending

article thumbnail

Variant Bio and Novo Nordisk to identify targets for metabolic disease treatment

Pharmaceutical Technology

Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.

Research 173
article thumbnail

Damaged Hearts May Have Hidden Self-Healing Powers, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.

article thumbnail

Vertex, startup Orna to partner on gene editing research

Bio Pharma Dive

The three-year partnership is another example of Vertex’s interest in improving on Casgevy, its CRISPR medicine for sickle cell and beta thalassemia.

article thumbnail

January 6, 2025: Fritz and Rhon to Present Strategies for Pain Management in the Military Health System

Rethinking Clinical Trials

In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for persons with chronic musculoskeletal pain is a priority in the Military Health System.

article thumbnail

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

article thumbnail

Light Horse emerges with $62m and Novartis partnership worth up to $1bn

Pharmaceutical Technology

Light Horses CEO said the biotechs initial focus will be on high-value and historically challenging oncology targets.

162
162
article thumbnail

Scientists Discover Common Virus Could Be Causing a Type of Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

CMV-infected human placental cell. (Nephron/CC BY-SA 3.0/Wikimedia Commons) Researchers have discovered a link between a chronic gut infection caused by a common virus and the development of Alzheimer’s disease in some people. Most people encounter cytomegalovirus (CMV) during childhood, and after the initial infection the virus remains in the body for life, usually dormant.

Scientist 246
article thumbnail

Orbis raises $93M to turn popular biologics into pills

Bio Pharma Dive

The startup is developing a kind of macrocyles, which share strengths of both small molecules and biologics, as oral medicines against “validated blockbuster biologic targets.

Medicine 297
article thumbnail

Amgen’s lung cancer treatment gets conditional approval

Pharma Times

IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer

159
159
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

FDA awards GSA breakthrough status for relapsed osteosarcoma treatment

Pharmaceutical Technology

GSK has gained US FDA breakthrough therapy designation for GSK'227 to treat adults with relapsed or refractory osteosarcoma.

162
162
article thumbnail

CDSCO releases draft standard evaluation protocols for issuing license for IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

Licensing 180
article thumbnail

Patrizia Cavazzoni, key FDA official, to leave agency

Bio Pharma Dive

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change.

Drugs 289
article thumbnail

January 8, 2025: In This Week’s PCT Grand Rounds, Community Engagement Methods in the FM-TIPS Trial

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.” The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern. FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among pati

Trials 183
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

Alzheimer’s total prevalent cases to reach 22.51 million in 8MM in 2033

Pharmaceutical Technology

GlobalData analysis suggests that China will lead with the highest number of prevalent cases of Alzheimers disease in 2033.

147
147
article thumbnail

NICE recommends olaparib for BRCA-mutated breast cancer treatment

Pharma Times

Groundbreaking approval provides new hope for patients in England and Wales

143
143
article thumbnail

Metsera reveals study data supporting long-acting obesity shot

Bio Pharma Dive

The startup, which has already raised more than half a billion dollars, released Phase 2 results that could position its drug as a future threat to weight loss medicines from Novo Nordisk and Eli Lilly.

Medicine 289
article thumbnail

Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Worldwide Clinical Trials

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential? BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicit

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

Climb Bio enters licensing deal with Mabworks for CLYM116 development

Pharmaceutical Technology

Climb Bio has entered an exclusive licence agreement with Beijing Mabworks Biotech for developing and commercialising CLYM116.

Licensing 147
article thumbnail

Angelini Ventures co-leads Series A financing in Neumirna Therapeutics

Pharma Times

Investment to support RNA therapeutics for epilepsy and neurological disorders

RNA 140
article thumbnail

Navigating future biopharma catalysts: What to expect at the 2025 J.P. Morgan Healthcare Conference

Bio Pharma Dive

The stage is set for JPM 2025—don't miss expert reactions following 2025’s principal catalyst event!

290
290
article thumbnail

Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

XTalks

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. Dr. Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional r

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Coave Therapeutics raises $33m in funding to advance ALIGATER platform

Pharmaceutical Technology

Coave has raised 32m ($33m) in a Series A financing round for advancing its Advanced Vectors-Ligand Conjugates (ALIGATER) platform.

147
147
article thumbnail

New prostate cancer test cuts biopsies by 50% in US

Pharma Times

EpiSwitch PSE shows promise in reducing unnecessary procedures

137
137
article thumbnail

IGM’s autoimmune pivot backfires as top drug disappoints in testing

Bio Pharma Dive

The biotech will stop developing two drugs and lay off nearly three-quarters of its staff after its lead therapy wasn’t as potent in early testing as the company expected.

Drugs 283
article thumbnail

How GenAI will transform life sciences in 2025

pharmaphorum

The life sciences industry is in a position to help humanity, perhaps more than ever, with the introduction of generative AI (GenAI).

article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.