August, 2024

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Cell and gene therapy investment, once booming, is now in a slump

Bio Pharma Dive

Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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Embracing innovation to drive clinical change in UK stroke care

pharmaphorum

Discover how the innovative geko device is driving clinical change in UK stroke care. Learn how this technology is revolutionising the treatment and management of stroke patients.

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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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New Brain Tumor Drug Voranigo (Vorasidenib) Targets Grade 2 IDH-Mutant Glioma

XTalks

The US Food and Drug Administration (FDA) has approved Voranigo (vorasidenib) for Grade 2 IDH-mutant glioma, a challenging brain tumor that has seen limited effective treatments for nearly 25 years. Developed by Servier Pharmaceuticals, Voranigo offers the first targeted therapy for patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma that harbor isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation.

Drugs 111
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Here Are All The Reasons Why You Should Enjoy Your Cup of Coffee

AuroBlog - Aurous Healthcare Clinical Trials blog

(iprogressman/Getty Images) Consuming too much caffeine is definitely bad for your health, and there may be good reasons why some people want to quit it altogether. But if you despair at the idea of giving up your morning coffee, fear not.

Research 246

More Trending

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Biotech Red Queen launches with $55M to build versatile antivirals

Bio Pharma Dive

The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.

Drugs 332
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Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials. By allowing protocol adjustments based on interim data analysis, these designs preserve the integrity of studies while effectively addressing the unique challenges of multi-regional clinical trials (MRCTs).

Trials 200
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August 29, 2024: HDRN Canada Pragmatic Trials Training Program Offers Open-Access Learning Modules

Rethinking Clinical Trials

A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. Every week, a new open-access module features essential resources and leading Canadian trialists discussing a key component of clinical trials. The 2-year, pan-Canadian program—HDRN Canada Pragmatic Trials Training Program—follows a structured curriculum that covers 12 key components of clinical tri

Trials 190
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Study reveals AI insights can predict development of disease a decade in advance

Pharma Times

The study predicted the development of conditions including Alzheimer’s and heart disease

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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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A Vital Fluid Protects Your Most Important Organ. What Happens if It Fails?

AuroBlog - Aurous Healthcare Clinical Trials blog

Cerebrospinal fluid, or CSF, is a clear, colorless liquid that plays a crucial role in maintaining the health and function of your central nervous system. It cushions the brain and spinal cord, provides nutrients and removes waste products. Despite its importance, problems related to CSF often go unnoticed until something goes wrong.

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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Bio Pharma Dive

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

Licensing 332
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The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans

Worldwide Clinical Trials

By: Simran Padam, Medical Director, Medical Affairs Personalized treatment approaches have emerged as pivotal in improving outcomes for hematological cancers. Central to this advancement are biomarkers, which are measurable indicators that signal biological processes or pathological changes within the body. They play a crucial role in tailoring hematology oncology therapeutic strategies to individual patients and have transformed personalized medicine in oncology.

Genetics 195
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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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August 7, 2024: How to Investigate Whether Buprenorphine Prevents Suicidal Behavior, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?” The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern. Simon is a senior investigator at KPWHRI and a research professor of psychiatry and behavioral sciences at the University of Washington.

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New drug trial to investigate treatment for patients with bronchiectasis

Pharma Times

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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FABA’s life sciences innovation cluster works on global partnerships to propel novel biologics & diagnostics

AuroBlog - Aurous Healthcare Clinical Trials blog

Federation of Asian Biotech Associations’ (FABA) Life Sciences Innovation Cluster is now working to strengthen the global partnerships to propel an ecosystem for novel biologics and diagnostics.

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Eli Lilly acquires Morphic in IBD portfolio expansion

Pharmaceutical Technology

Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.

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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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With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

Bio Pharma Dive

Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.

Drugs 325
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Novartis and Viatris sued by estate of Henrietta Lacks, whose cells were extracted for research in 1951

Fierce Pharma

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

Research 145
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August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials

Rethinking Clinical Trials

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that addresses the urgent need for better and faster implementation of research findings into pat

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National campaign launches to end prostate cancer postcode lottery

Pharma Times

Over 135,000 people have signed a petition to prioritise a national screening programme

Research 156
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Sexually Transmitted Infections Are Rising in Older People, And This May Be Why

AuroBlog - Aurous Healthcare Clinical Trials blog

Diagnoses for sexually transmitted infections, or STIs, are increasing in older adults. The Centers for Disease Control and Prevention reports the number of people older than 65 diagnosed with chlamydia, gonorrhea or syphilis in the U.S. increased about three-, five- and sevenfold, respectively, from 2010 to 2023.

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US FDA approves Novartis’ Fabhalta in IgAN treatment

Pharmaceutical Technology

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

Bio Pharma Dive

The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.

Research 322
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BioNTech posts €808M loss as company continues to come to grips with seasonal COVID vaccine market

Fierce Pharma

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

Vaccine 145
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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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August 26, 2024: iPATH Trial Aims to Improve Diabetes Care in Community Health Centers

Rethinking Clinical Trials

The iPATH trial, one of the newest additions to our portfolio of NIH Collaboratory Trials , is testing the implementation of a practice transformation strategy for patients with type 2 diabetes in federally qualified health centers (FQHCs) in California, Massachusetts, Ohio, and Puerto Rico. We asked the principal investigator for iPATH, Sara Singer of Stanford University, to tell us more about her innovative study.

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Study finds AI reduces underdiagnosis of Black patients with common heart failure

Pharma Times

Heart failure with preserved ejection fraction makes up 50% of all UK heart failure cases

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Hospitals Are Running Out of Saline, And It’s a Global Problem

AuroBlog - Aurous Healthcare Clinical Trials blog

Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. The shortage is due to higher-than-expected demand and manufacturing issues. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution). Both fluids are made with salts.

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Conduit acquires three first-in-class assets from AstraZeneca 

Pharmaceutical Technology

Conduit plans to advance two assets, AZD1656 and AZD5658, into Phase II testing for autoimmune disorders.

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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?