Mon.Mar 10, 2025

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March 10, 2025: Developing Monitoring Plans Warrants Special Attention in Pragmatic Clinical Trials

Rethinking Clinical Trials

In an article published online ahead of print , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk. Challenges specific to pragmatic trials include: complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites embedding of interventions in clinical

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Novo’s Wegovy successor disappoints in second large trial

Bio Pharma Dive

A study in people with obesity and diabetes again found CagriSema helps people lose weight, but not by enough to clearly surpass Eli Lilly’s Zepbound.

Trials 290
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AstraZeneca and Ionis win EU approval for ATTR polyneuropathy

Pharmaceutical Technology

AstraZeneca and Ionis are intensifying their competition with Alnylam by securing an EU approval for Wainzua.

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Beam base editing therapy gets ‘proof of concept’ in rare lung disease

Bio Pharma Dive

While initial study results suggest Beam's technology can correct alpha-1 antitrypsin deficiency's genetic roots, shares fell by double digits.

Genetics 279
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

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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Artificial intelligence is making clinical supply chains more efficient and more sustainable: here’s how

Pharmaceutical Technology

The potential applications of artificial intelligence (AI) in biopharmaceuticals appear wide-ranging and transformative.

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SynWeave™: Revolutionizing biopharma manufacturing by improving titer, timelines and manufacturability

Bio Pharma Dive

Enhancing manufacturability is crucial for reducing the risks associated with scaling production.

More Trending

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Mineralys shares climb on study data for blood pressure drug

Bio Pharma Dive

Findings from a pair of studies in tough-to-treat hypertension establish Mineralys’ drug as a “derisked, almost-commercial stage cardiometabolic asset,” wrote one analyst firm following the company.

Drugs 189
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Vaccinex plans Nasdaq exit as Alzheimer market pressure grows

Pharmaceutical Technology

Following equity shortcomings, Vaccinex ends its journey as a public company after six and a half years.

Marketing 147
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3 ways to accelerate development and de-risk cell and gene therapy manufacturing

Bio Pharma Dive

Development strategies designed to reduce the unknowns so that cell and gene therapy innovators can develop robust processes efficiently.

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IA-2A positivity identified as a key predictor in type 1 diabetes progression

Pharmaceutical Technology

A recent study published in Diabetologia has identified insulinoma-associated protein 2 autoantibody (IA-2A) positivity as a significant marker for disease progression in individuals at risk of type 1 diabetes (T1D).

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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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PI Perspective: Notes From a U.K. Site Alliance Network Event

Velocity Clinical Research

Luke Boylan, MBChB, MBA, Principal Investigator at Velocity in North London, recently attended the Parexel Site Alliance Network event. This collaborative gathering included NHS/NIHR-affiliated sites and other commercial research organizations, providing an invaluable opportunity to discuss the evolving landscape of clinical trials in the U.K. Dr. Boylans key takeaways from the event: Regulatory Improvements: There was strong consensus from the MHRA on the need for faster regulatory approval tim

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Alliance Pharma agrees to £362m acquisition by DBAY

Pharmaceutical Technology

The offer represents a 3.6% increase from the initial offer in January 2025, from 62.5 pence per share to 64.75 pence per share.

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The Impact of Technological Advances on Generic Drug Development

Drug Patent Watch

The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. From AI-powered discovery to 3D printing, the latest advancements are not only speeding up the process but also making it more efficient and cost-effective.

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EC approves BMS’ Opdivo and Yervoy combo for HCC

Pharmaceutical Technology

The EC has approved BMS Opdivo in combination with Yervoy as a first-line treatment for adults with unresectable or advanced HCC.

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

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DDW Highlights: 10 March 2025

Drug Discovery World podcast

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. Our news round-up this week focuses on start-ups, the innovative fledgling companies that are coming through and sparking new life into various areas of drug discovery.

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Sun Pharma to acquire Checkpoint Therapeutics

Pharmaceutical Technology

Sun Pharmaceutical has agreed to acquire Checkpoint Therapeutics for an aggregate consideration of up to $355m upfront.

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The Patent Playbook for Pharma: Protect Your Drug. Protect Your Profits.

Drug Patent Watch

The Secret to Protecting Your Pharmaceutical Innovations: A Proven Patent Strategy As a pharmaceutical professional, you know how crucial it is to safeguard your groundbreaking discoveries. But with the ever-changing landscape of patent law, it's easy to get left behind. That's why we've put together a comprehensive guide to help you navigate the complex world of pharmaceutical patents.

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Beam launches $500m financing on base-editing trial data

pharmaphorum

Beam says its base-editing drug has met its goals in a phase 1/2 trial in genetic disease AATD, and it wants to raise $500m to take it forward

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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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Strategic Trends in Pharmaceutical Manufacturing for Industry Leaders

Pharmaceutical Commerce

This link in the pharma supply chain is undergoing a major transformation propelled by technological advancements, regulatory changes, and evolving market dynamics, requiring industry leaders to adopt innovative strategies in order to remain competitive.

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Sun Pharma buys Checkpoint and its new cancer drug

pharmaphorum

Sun Pharma has agreed to acquire Checkpoint Therapeutics, which recently claimed FDA approval for its first drug but is also running short on cash

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Pharma Pulse 3/10/25: NIH’s Role in New Drug Development, Future Directions in Biosimilar Health Care Delivery & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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EU clears AZ, Ionis' Wainzua for ATTR polyneuropathy

pharmaphorum

AstraZeneca and Ionis add an EU green light to earlier approvals in the US and UK for ATTR polyneuropathy drug Wainzua, a potential blockbuster

Drugs 59
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The Case for Reshoring Manufacturing to the United States

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDOs national life sciences co-leader, discusses how the tariffs impact the reshoring of manufacturing services, alongside the strategies that pharma leaders can use in order to start shoring up their supply chains.

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J&J shows its confidence in oral IL-23 drug for psoriasis

pharmaphorum

J&J wants to turn the screw in the psoriasis market with a new head-to-head trial pitting oral IL-23 drug icotrokinra against Stelara

Drugs 59
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Omlyclo Becomes First Biosimilar to Rival Xolair

XTalks

Genentechs asthma drug Xolair (omalizumab) now faces its first competitive biosimilar. The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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Changing Faces: Pharma and biotech hires – February 2025

pharmaphorum

Explore the latest hires and talent movements in the pharma and biotech industry for February 2025, featuring companies like Pfizer, Boehringer Ingelheim, UCB, Novo Nordisk, and more. Stay updated on industry trends and key personnel changes.

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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.

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TNKase (Tenecteplase) Becomes First Stroke Medicine Approved by FDA in Almost 30 Years

XTalks

The FDA has approved Genentechs TNKase (tenecteplase) for the treatment of acute ischemic stroke in adults, marking a milestone as the first new stroke medicine approved in nearly three decades. TNKase, a clot-dissolving agent, offers a faster and simpler alternative to current treatment options, delivered as a single fivesecond intravenous (IV) bolus.

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12 Questions with Giancarlo Benelli

pharmaphorum

We sit down with Giancarlo Benelli for an exclusive interview that covers 12 thought-provoking questions. Get insights and inspiration from this engaging conversation.

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Malfunctioning Fat Tissue Could Affect How Easily We Lose Weight

AuroBlog - Aurous Healthcare Clinical Trials blog

Many people who have struggled with their weight have been told to “eat less and move more.” Others have spent years juggling trendy diets, from keto to fasting, with minimal results. Despite their best efforts, what they often hear from physicians, friends, family and even strangers, is that they lack discipline.

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Novo Nordisk's CagriSema data disappoints investors again

pharmaphorum

Novo Nordisk's obesity candidate CagriSema has underwhelmed in a second phase 3 trial, sending the company's share into a sharp decline

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud