Sat.Jul 06, 2024 - Fri.Jul 12, 2024

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July 10, 2024: Asking Different Causal Questions in Randomized Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Miguel Hernán In this Friday’s PCT Grand Rounds, Miguel Hernán of Harvard University will present “Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them?” The Grand Rounds session will be held on Friday, July 12, 2024, at 1:00 pm eastern. Hernán is the Kolokotrones Professor of Biostatistics and Epidemiology and the director of the CAUSALab at Harvard T.H.

Trials 183
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Current Clinical Research Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment

Worldwide Clinical Trials

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

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Ozempic And Similar Drugs Lower Cancer Risks, Study Suggests

AuroBlog - Aurous Healthcare Clinical Trials blog

A class of diabetes medications, which include the best-selling drug Ozempic, are associated with a reduced risk of certain obesity-related cancers, according to a study released Friday.

Insulin 246
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Pfizer research chief Dolsten to step down, with company at a crossroads

Bio Pharma Dive

The company has begun searching for a successor to Dolsten, who oversaw more than 35 drug and vaccine approvals but also some notable setbacks during his time as Pfizer’s top scientist.

Scientist 304
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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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Myricx Bio gains $114m in Series A round to develop NMTi-ADCs

Pharmaceutical Technology

Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.

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UK DRI and NHS collaborate on digitally enabled dementia care platform

Pharma Times

Around one in five dementia hospitalisations are due to potentially preventable causes

Research 168

More Trending

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Pfizer thinks it found its obesity pill

Bio Pharma Dive

Far behind companies like Novo and Eli Lilly, Pfizer hopes the version of the drug, danuglipron, that it’s chosen to advance can break into the ultra-lucrative market for weight-loss medicines.

Medicine 315
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NHS rolls out “more convenient” Ocrevus injection for multiple sclerosis

Pharmaceutical Technology

The subcutaneous formulation of Roche’s blockbuster Ocrevus will cut hospital treatment time for patients.

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Francis Crick and ICL spinout raises £90m to clinically develop cancer treatments

Pharma Times

Myricx Bio’s therapies include treatments for breast, lung and colorectal cancer

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CDSCO issues guidance document on export NOC for unapproved, banned and new drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.

Drugs 245
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Lilly to buy Morphic in $3B bet on inflammation drug

Bio Pharma Dive

The deal would hand Lilly an experimental pill that could one day rival Takeda's blockbuster medicine Entyvio as a treatment for inflammatory bowel disease.

Medicine 297
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NICE recommends Ebglyss for atopic dermatitis patients

Pharmaceutical Technology

Almirall’s Ebglyss is predicted to hit blockbuster status in two years in the crowded atopic dermatitis market.

Marketing 264
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Coloplast launches digital leakage notification system Heylo for stoma patients

Pharma Times

More than 176,000 people in the UK are living with a stoma, according to NHS data

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It’s Official: WHO Warns Talc Is ‘Probably Carcinogenic’ For Humans

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization‘s cancer agency on Friday classified talc as “probably carcinogenic” for humans, however an outside expert warned against misinterpreting the announcement as a “smoking gun” The decision was based on “limited evidence” talc could cause ovarian cancer in humans, “sufficient evidence” it was linked to cancer in rats and “strong mechanistic evidence” […]

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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

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Bristol Myers’ leukemia blockbuster set to face first generic rival

Bio Pharma Dive

Patent litigation has opened the door to generic copies of Bristol Myers’ Sprycel arriving in the U.S. as soon as September.

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GSK and MVV launch malaria medicine in Brazil and Thailand

Pharmaceutical Technology

GSK and MMV have announced the launch of tafenoquine to prevent the relapse of P. vivax malaria in Brazil and Thailand.

Medicine 256
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SMC accepts Boehringer/Lilly’s Jardiance for CKD within NHS Scotland

Pharma Times

The serious, progressive kidney disease affects nearly 850 million people worldwide

Medicine 150
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NIPERs need to establish comprehensive ecosystem for entrepreneurship: DoP study

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institutes of Pharmaceutical Education and Research (NIPERs) need to establish more comprehensive ecosystem that includes mentorship, support for incubation, funding methods, and industrial alliances to promote entrepreneurship in the pharmaceutical sector, which can also substantially help these institutes to foster self-reliance, according to a study.

Research 238
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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.

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A London biotech raises $114M to hone a new ADC payload

Bio Pharma Dive

Myricx Bio is developing a type of payload that it thinks could work in tumors resistant to the toxins contained in ADCs like Enhertu and Trodelvy.

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Ipsen gains global rights to Foreseen Biotech’s FS001 ADC

Pharmaceutical Technology

Ipsen has entered an exclusive global licensing agreement with Foreseen Biotech for FS001, a potentially first-in-class ADC.

Licensing 246
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Institutions to lead £1.7m-funded network to support people at risk of dementia

Pharma Times

The neurodegenerative condition currently affects more than 944,000 people in the UK

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AVPRF pioneers evidence-based Ayurveda and integration of modern medicine

AuroBlog - Aurous Healthcare Clinical Trials blog

By focusing on clinical excellence, comprehensive education, and cutting-edge research, the Arya Vaidya Pharmacy Research Foundation (AVPRF) based in Coimbatore is ensuring that ayurvedic practices are validated, credible, and relevant for future generations. This holistic approach not only enhances the field of Ayurveda but also promises better health outcomes for patients worldwide, says Dr.

Medicine 232
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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.

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FDA’s lab-developed test rule could be first test of agency’s power post-Chevron

Bio Pharma Dive

The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

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Evotec and Pfizer announce drug discovery collaboration

Pharmaceutical Technology

Evotec and Pfizer have entered a multi-year partnership that will focus initially on early discovery research.

Drugs 246
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Innovate UK grants £4m to four companies to evaluate biomarkers for dementia

Pharma Times

The progressive neurodegenerative disease affects more than 55 million people globally

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Find It Hard to Focus? You May Have Cognitive Disengagement Syndrome

AuroBlog - Aurous Healthcare Clinical Trials blog

Do you find that you daydream a lot? Are you often sluggish and tend to disengage easily when doing a task? You might have cognitive disengagement syndrome, or CDS.CDS was first described by psychologists in the 1960s and 1970s when they noticed that some people display these traits more persistently than others.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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HilleVax’s norovirus vaccine ineffective in large trial of infants

Bio Pharma Dive

Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

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Lilly bolsters IBD portfolio with $3.2bn Morphic acquisition

Pharmaceutical Technology

Morphic’s lead asset MORF-057 is being investigated in three IBD clinical trials, with data in ulcerative colitis expected next year.

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New policy review reveals ten cancer challenges facing new UK government

Pharma Times

Macmillan Cancer Support estimates that cancer affects over three million people in the UK

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IPC-MvPI awarded provisional approval as certification body for ICMED 9000 and ICMED 13485

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) has received provisional approval from the Quality Council of India (QCI) to operate as a certification body for the ICMED 9000 and ICMED 13485 certification schemes.

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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.