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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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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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 334
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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 189
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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NICE recommends BeiGene’s MZL tablet for NHS use

Pharmaceutical Technology

The UK NICE has recommended BeiGene’s Zanubrutinib for marginal zone lymphoma (MZL) for use on the National Health Service (NHS).

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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 334
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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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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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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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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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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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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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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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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 328
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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 143
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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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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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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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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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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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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 325
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AMR testing technology from QuantaMatrix backed by research paper in Nature

Pharma Times

The new test takes an average of 13 hours to identify the correct treatment compared to several days with current methods

Research 139
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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.

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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.

Trials 162
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Bayer layoffs hit Switzerland with 150 cuts at Basel consumer health hub: reports

Fierce Pharma

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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Here’s What ‘Diet’ Soft Drink Could Be Doing to Your Health in The Long Term

AuroBlog - Aurous Healthcare Clinical Trials blog

Many people are drinking less sugary soft drink than in the past. This is a great win for public health, given the recognised risks of diets high in sugar-sweetened drinks. But over time, intake of diet soft drinks has grown. In fact, it’s so high that these products are now regularly detected in wastewater.

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Emergent joins mpox fight with 50,000 vaccine dose donation to Africa

Pharmaceutical Technology

Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.

Vaccine 263
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g