July, 2024

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

Marketing 299
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Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

Bio Pharma Dive

The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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July 23, 2024: Article From Ethics and Regulatory Core Highlights Key Challenges for Pragmatic Trials

Rethinking Clinical Trials

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp

Trials 317
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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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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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Why Is Antimicrobial Resistance Not Getting Much Attention from Biopharma?

BioSpace

Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.

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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 231

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Pfizer quits Duchenne gene therapy, lays off staff following study setback

Bio Pharma Dive

The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.

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WorldwideEdge: Driving Innovation in Bioanalytical Lab Run Success Rates

Worldwide Clinical Trials

At Worldwide Clinical Trials’ bioanalytical lab, we view challenges as opportunities to excel and set new standards. The path to drug approval is complex, with many variables and potential delays. That’s why our team is committed to continuous improvement through our initiative, WorldwideEdge, where we optimize everything from our processes to our teams’ performance for each drug development program.

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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 182
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Study suggests targeting amyloid beta production could be promising in AD

Pharma Times

The neurodegenerative disease is currently the most common cause of dementia

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

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One Diet Choice While Pregnant May Protect Your Child’s Heart For Life

AuroBlog - Aurous Healthcare Clinical Trials blog

The food consumed by a pregnant mother just got a little bit more important. According to a new study on pregnant mice, a diet rich in fiber improves the long-term heart health of developing offspring, significantly lowering their risk of cardiovascular disease later in life.

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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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Lilly drug for Alzheimer’s approved by FDA

Bio Pharma Dive

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

Drugs 338
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Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

Fierce Pharma

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

Drugs 135
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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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July 24, 2024: In This Week’s PCT Grand Rounds, Fonarow to Discuss Interventions for Optimizing Guideline-Directed Medical Therapy

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Gregg Fonarow of the University of California, Los Angeles, will present “Interventions for Optimization of Guideline-Directed Medical Therapy.” The Grand Rounds session will be held on Friday, July 26, 2024, at 1:00 pm eastern. Fonarow is the Eliot Corday Professor of Cardiovascular Medicine and Science at UCLA, director of the Ahmanson-UCLA Cardiomyopathy Center, and codirector of the UCLA Preventative Cardiology Program.

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NeuroSense Therapeutics shares positive results of lead candidate in ALS

Pharma Times

The neurodegenerative disease currently affects more than 200,000 people worldwide

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Eyelash Extensions Can Be Seriously Dangerous, Expert Warns

AuroBlog - Aurous Healthcare Clinical Trials blog

Ultra long, thick eyelashes might be in vogue but are they worth the expense – and the risk to health? Our natural eyelashes perform important functions. The eye is exposed to the elements so it’s a window for bacteria and viruses to enter the body – potentially causing death.

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FDA launches new rare disease innovation hub

Pharmaceutical Technology

The new hub will act as a central point of connection and engagement for the rare disease community for FDA-related concerns.

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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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10 clinical trials to watch in the second half of 2024

Bio Pharma Dive

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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Type 2 Diabetes: Challenges & Emergent Strategies for Clinical Research

Worldwide Clinical Trials

With advancements in technology and a deeper understanding of type 2 diabetes (T2D), therapeutics, such as GLP-1 agonists and continuous glucose monitors (CGM), have significantly improved care options for patients with T2D. Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D.

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July 31, 2024: Gene Editing Therapies and Population Health, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Adrian Hernandez In this Friday’s PCT Grand Rounds, Adrian Hernandez of Duke University will present “Precision Health to Population Health: Opportunities and Challenges for Gene Editing Therapies.” The Grand Rounds session will be held on Friday, August 2, 2024, at 1:00 pm eastern. Hernandez is a professor of medicine and vice dean in the Duke University School of Medicine and the executive director of the Duke Clinical Research Institute.

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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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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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New Alzheimer’s Nasal Spray Clears Toxic Tangles in Human Neurons And Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success.

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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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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

Bio Pharma Dive

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

Medicine 319
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CDMOs: Shaping The Future of Pharmaceutical Innovation

Pharma Mirror

The pharmaceutical industry is constantly shifting, as consumers seek the best treatments. As the market demands new solutions, drugmakers are tasked with investing heavily in research, development, manufacturing and commercialization. Meeting the needs of the sector can be challenging, especially for companies that don’t have the necessary resources.

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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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July 17, 2024: In This Week’s PCT Grand Rounds, Lessons From the PRECIDENTD Comparative Effectiveness Trial

Rethinking Clinical Trials

Dr. Brendan Everett and Dr. Deborah Wexler In this Friday’s PCT Grand Rounds, Brendan Everett and Deborah Wexler of Harvard Medical School will present “Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial.” The Grand Rounds session will be held on Friday, July 19, 2024, at 1:00 pm eastern. The PRECIDENTD study (Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes) is comparing SGLT2 inhibitors and a GLP-1 receptor agonist to treat type 2

Trials 147
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Study finds 3D-printed blood vessels could improve heart bypass outcomes

Pharma Times

Coronary heart disease is the most common form of heart and circulatory disease

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New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills.

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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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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