Worldwide Clinical Trials

APRIL 28, 2025

Following the American College of Cardiology (ACC) conference 2025, Worldwide Clinical Trials hosted a post-meeting webinar, On the Cutting Edge of Cardiovascular Discovery Learnings from ACC 2025 and Future Perspectives. From the presentation of the REVERSE-IT and STRIDE trials to additional studies on lipid-lowering therapies and heart failure treatments, this webinar reflected on key study results and their implications for future cardiovascular research.

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Bio Pharma Dive

APRIL 25, 2025

The drug, being developed for a rare genetic disorder and currently under review in the U.S., is seen by some investors as critical to Biohaven’s future.

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Rethinking Clinical Trials

APRIL 22, 2025

Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was published online ahead of print this week in Learning Health Systems.

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Bio Pharma Dive

APRIL 21, 2025

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.

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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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ACRP blog

APRIL 25, 2025

At the latest meeting of the Association of Clinical Research Professionals (ACRP)-led Partners Advancing the Clinical Research Workforce (PACRW) consortium, the focus for these extraordinary times in human subjects research was on what levers need to be pulled by the consortiums members to bend the curve toward a better future for stakeholders in what is often an under-recognized and under-resourced segment of the larger healthcare workforce.

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Pharmaceutical Technology

APRIL 23, 2025

The lawsuit filings are the latest turn in a long-running legal saga between GLP-1RAs makers and compounders.

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FDA Law Blog

APRIL 21, 2025

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a

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ACRP blog

APRIL 26, 2025

With recent federal actions upending business as usual for many stakeholders in the clinical research enterprise, some of its thought leaders pondered the big question of Where does clinical research go from here? during Fridays (April 25) first Signature Series gathering at ACRP 2025 in New Orleans. After the heartfelt session closed with a Big Easy-style second line jazz band sendoff, an expert lineup of educational session presenters held forth on an array of vital topics for members of the i

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Pharmaceutical Technology

APRIL 22, 2025

Roche is set to invest $50bn in pharmaceuticals and diagnostics in the US over the coming five years to bolster its presence in the country.

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XTalks

APRIL 25, 2025

This week, LEO Pharma announced the publication of pivotal Phase III clinical trial results in The Lancet for its topical delgocitinib cream to treat severe chronic hand eczema (CHE). Results from the trial showed delgocitinib to have superior efficacy and safety over oral alitretinoin, the current standard of care for CHE. The DELTA FORCE trial is the first head-to-head Phase III study comparing a topical treatment with a systemic therapy for CHE.

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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!

Clinical Trials

Bio Pharma Dive

APRIL 22, 2025

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S.

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Drug Patent Watch

APRIL 22, 2025

"The Russian Pharmaceutical Industry: A Strategic Evolution Unfolding As the global pharmaceutical landscape continues to shift, one country is making a bold move: Russia. With a growing focus on domestic production and technological innovation, the Russian pharmaceutical industry is poised for significant growth. In this in-depth report, we dive into the key players, strategic evolution, and technological advancements driving the industry forward.

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ACRP blog

APRIL 22, 2025

This is a sponsored message. Helen Keller once wrote: True happiness is not attained through self-gratification, but through fidelity to a worthy purpose. Nothing could be truer for the millions of clinical research professionals steadfastly committed to helping advance treatments that transform lives. These everyday unsung heroes occupy every corner of our industry from small clinician-run sites to large academic medical centers; from global pharmaceutical companies to nimble biotech startups

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Pharmaceutical Technology

APRIL 24, 2025

Biogen Netherlands has received marketing authorisation from the UK MHRA for its Skyclarys to treat Friedreich's ataxia.

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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

Medicine

XTalks

APRIL 22, 2025

As the prevalence of metabolic diseases such as diabetes, obesity and prediabetes continues to rise globally, there is an urgent need for innovative therapies that move beyond traditional hormone replacement strategies. Steffen-Sebastian Bolz, MD, PhD Executive Board Member, Chief Scientific Officer Aphaia Pharma Aphaia Pharma is redefining the landscape of metabolic disorder treatment by leveraging the bodys inherent biological processes.

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Bio Pharma Dive

APRIL 24, 2025

The drugmaker absorbed additional tariff-related costs in the first quarter, but has taken steps to lower the financial impact it’ll have for the rest of the year and beyond.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 27, 2025

The Parliamentary Panel on Health and Family Welfare has recommended to the National Commission of Homoeopathy (NCH), under the Ministry of Ayush, to work towards increasing faith of the public in Homeopathy by taking necessary steps to assess the efficacy of the treatment system.

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Drug Discovery World podcast

APRIL 28, 2025

The latest episode of the DDW Highlightspodcast is now available to listen to below. DDWs Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. With Eli Lilly so far winning the race to bring an oral GLP-1 drug to market, having announced positive topline results from a Phase III trial, this week our news highlights focus on clinical studies.

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Pharmaceutical Technology

APRIL 23, 2025

The agreement gives Boehringer access to Tessellates novel approach targeting ALT-dependent tumours.

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XTalks

APRIL 22, 2025

As consumer interest in protein-enriched foods continues to grow, food manufacturers are increasingly seeking high-quality, functional ingredients that enhance both nutrition and sensory appeal. Plant-based proteins are interesting as versatile solutions for a wide range of food applications. The use of faba bean is gaining traction in a wide range of savoury applications.

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Bio Pharma Dive

APRIL 24, 2025

The biotech is using AI and a trove of health data to better understand why certain conditions progress and intervene beforehand with a targeted medication.

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Drug Patent Watch

APRIL 22, 2025

"Game Changer Alert: Are You Leaving Millions on the Table? As a pharmaceutical executive, you know the importance of staying ahead of the competition. But are you overlooking a crucial aspect of your generic launch strategy? I recently came across a fascinating article from @DrugPatentWatch that highlights the untapped potential of integrating clinical trials and the 505(b)(2) pathway into your pharmaceutical portfolio management.

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Clinical Trials Clinical Trials Trials Marketing 53

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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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Pharma Times

APRIL 22, 2025

The SHIELD-Utah study compared Novavaxs vaccine to Pfizer/BioNTech mRNA 2024 to 2025 vaccine

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Pharmaceutical Technology

APRIL 28, 2025

Amgen has announced a significant expansion of the Ohio manufacturing facility in the US, with an investment of $900m.

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Manufacturing 191

Medical Xpress

APRIL 26, 2025

Even for patients covered by Medicare, annual out-of-pocket costs for lifesaving cancer treatments taken in pill form have often exceeded $10,000until recently. Thanks to changes in Medicare Part D introduced by the Inflation Reduction Act (IRA) that took effect in 2025, annual out-of-pocket drug costs for all beneficiaries are now capped at $2,000.

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Bio Pharma Dive

APRIL 25, 2025

The CRISPR company is laying off about a third of its employees and stopping work on an experimental lupus treatment in a bid to focus resources on a pair of cancer cell therapies.

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Life Science

Drug Discovery World podcast

APRIL 22, 2025

The latest episode of the DDW Highlightspodcast is now available to listen to below. DDWs Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In a week of financial uncertainty for the industry, our round-up focuses on the power of partnership to accelerate drug discovery, from the prevention of respiratory infections, to mapping gene activity in inflammatory bowel disease.

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Crucial Data Soutions

APRIL 22, 2025

The Evolution of Remote Patient Monitoring in Clinical Trials Remote patient monitoring (RPM) has come a long way from the. The post The Future of Remote Patient Monitoring in Decentralized Clinical Trials appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

APRIL 25, 2025

Despite the decision being a win for Novo Nordisk, the compounded drugs sector is far too complex for this to be a final resolution.

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Drugs 189

Medical Xpress

APRIL 26, 2025

As the opioid crisis continues, the number of babies born with neonatal opioid withdrawal syndrome (NOWS)a condition that affects infants whose mothers used opioids during pregnancyhas risen 5-fold over the past 20 years. According to the Centers for Disease Control (CDC), there are 20,000 infants a year in the United States born with signs of NOWS.

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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.

Clinical Research