Mon.May 13, 2024

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Shionogi's antiviral comes up short in global COVID-19 trial

Fierce Pharma

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.

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DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference?

MedCity News

The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry. The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? appeared first on MedCity News.

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As Bristol Myers reveals trial failure, AstraZeneca's Imfinzi stays king in stage 3 lung cancer

Fierce Pharma

Another attempt at improving upon AstraZeneca’s Imfinzi in stage 3, unresectable non-small cell lung cancer (NSCLC) has gone up in flames. | Following AstraZeneca's setback in attempting to improve upon Imfinzi's efficacy in unresectable stage 3 lung cancer, a Bristol Myers Squibb endeavor has gone up in flames, as well. Now, market watchers are turning their attention to upcoming readouts from Merck & Co. and Roche.

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Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model

MedCity News

As more hospitals across the country shut down their maternity wards, a Sutter Health-owned hospital in Berkeley has taken proactive steps to ensure it can continue providing care for the pregnant people in its community. The hospital partnered with Millie, a Berkeley-based startup offering hybrid maternal care from midwives and doulas. The post Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model appeared first on MedCity News.

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

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Johnson & Johnson looks to offload remaining Kenvue stake in $3.75B deal

Fierce Pharma

After Johnson & Johnson's consumer healthcare spinoff last year—and its subsequent reduction in holdings in the new company—the healthcare conglomerate is once again cutting its stake in&n | Johnson & Johnson is again cutting its holdings in Kenvue. This time, it's pursuing a "debt-for-equity" offering that looks to be worth about $3.75 billion.

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Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business

MedCity News

In part 2 of our Q&A, Okamura addresses the need for biopharma companies to leverage digital technologies in disease management. The post Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business appeared first on MedCity News.

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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Unlocking health equity: The promise of digital health technologies

Fierce Pharma

What is the transformative potential of digital health technologies in advancing health equity? | Digital health technologies can transform lives and help advance health equity—if applied correctly. Rabin Martin, a global health consulting firm, explores those possibilities in this must-listen podcast.

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America Is Losing One of Its Most Precious Assets: Our Brain Power

MedCity News

Investing in youth brain capital is not just a moral imperative. It is an economic necessity. The post America Is Losing One of Its Most Precious Assets: Our Brain Power appeared first on MedCity News.

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Impact of EU sustainability directive on supply chains

European Pharmaceutical Review

Eighty four percent of pharmaceutical and healthcare companies consider that the new EU Corporate Sustainability Due Diligence Directive (CSDDD) directive is an opportunity to “align human rights and environmental protection with their business objectives”, findings from a survey by supply chain specialist INVERTO has found. EU operations must comply with the new directive.

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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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Takeda Commits $100M for Chance to Bring Immunotherapy to Alzheimer’s Disease

MedCity News

Takeda Pharmaceutical has secured an option on an Alzheimer’s disease immunotherapy from AC Immune that is on track to report its first Phase 2 data later this quarter. Exercising the option would make Takeda responsible for Phase 3 testing of the therapy, putting AC Immune in line for up to $2.1 billion in milestone payments. The post Takeda Commits $100M for Chance to Bring Immunotherapy to Alzheimer’s Disease appeared first on MedCity News.

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Sanofi to invest €1bn in France to lift ‘health sovereignty’

pharmaphorum

Sanofi will invest more than €1 billion ($1.08 billion) in new bioproduction capacity at three manufacturing sites in France as part of a €3.5 billion programme in the country. The latest tranche of investment – at Vitry-sur-Seine in Val de Marne, Le Trait in Seine-Maritime, and Lyon Gerland in the Rhône region – is part of a drive to reduce the reliance of France and the wider EU on manufacturing capacity in other parts of the world and boost supply chain security and resiliency.

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Lycia Therapeutics Lands $106M for Protein Degraders That Treat Autoimmune & Inflammatory Diseases

MedCity News

Eli Lilly-partnered Lycia Therapeutics will use its Series C financing to continue developing its internal pipeline of protein-degrading drugs. The startup is working to reach the clinic with drugs for autoimmune and inflammatory disorders. The post Lycia Therapeutics Lands $106M for Protein Degraders That Treat Autoimmune & Inflammatory Diseases appeared first on MedCity News.

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Wearable device ‘may prevent heart failure hospitalisation’

pharmaphorum

Monitoring of heart failure patients at home using a wearable developed by ADI has shown in a new study that it may be able to reduce costly hospitalisations

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Dementia Action Week 2024: the future of Alzheimer’s diagnostics  

Pharmaceutical Technology

As the debate over using tau levels to guide patient treatment persists, the landscape for Alzheimer’s diagnostics continues to move ahead.

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MSD has another TIGIT programme setback

pharmaphorum

A phase 3 trial of MSD’s TIGIT antibody has been abandoned after a high rate of discontinuations rendered the study futile

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Healthcare Investment Trends Take Center Stage at MedCity INVEST

MedCity News

The boutique healthcare investment conference in Chicago is scheduled for May 21-22. Space is limited so register today! The post Healthcare Investment Trends Take Center Stage at MedCity INVEST appeared first on MedCity News.

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5 trends impacting drug spend in the U.S.

PharmaVoice

Key factors changing how much Americans spend on prescriptions.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Talking Strategic Development with Simtra at DCAT

PharmaTech

Ray Guidotti, Chief Operating Officer at Simtra BioPharma Solutions, talks about the company's strategic development and how it supports customers with a focus on excellence.

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Pharma Pulse 5/13/24: WomenHeart and Bayer Join Forces, Managing Medications During Sick Days & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Customized solutions for biologics development: leveraging adaptive platforms to meet customer needs

PharmaTech

Choosing the right CDMO is a strategic decision that can significantly impact the success of biologics development. By evaluating a CDMO’s ability to adapt programs to specific protein therapies and manufacturing needs, leverage specialized expertise, offer integrated solutions and overcome industry challenges, manufacturers can make informed decisions that maximize their chances of project success.

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Cold Chain Solutions Supplement: Further Exploration of Pharma’s Temperature-Controlled Sector

Pharmaceutical Commerce

Post LogiPharma, the editors of Pharmaceutical Commerce examine the trends and highlights that came out of the conference, specifically surrounding the cold chain solutions segment. This digital supplement offers an overview of this niche sector’s value to the industry, and through exclusive video interviews with key opinion leaders and session coverage, provides perspectives from subject matter leaders on issues that they find most relevant, including matters pertaining to third-party logistics

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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

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Strategies and tactics for success in biologics analytical testing

PharmaTech

Well-designed analytical testing of biologics is essential during every stage of biopharmaceutical development to ensure the safety and quality of the drug and provides an important feedback loop during development. In this article, Bora Biologics delves into the significance of rigorous analytical testing, highlighting strategies to meet regulatory standards and enhance processes effectively.

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Today’s New Messaging Mix: The State of Pharma Marketing in 2024

PharmExec

Industry experts, in a roundtable discussion, explore the evolution of brand engagement in the age of AI, including the growing importance of message relevance—and, for pharma, going where the information is.

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Addressing the complex demands of cell line development

PharmaTech

Having a robust Cell Line Development (CLD) strategy is the foundation of biologic production that can propel a project, helping to streamline production while mitigating risk. A tailored and optimized cell line can be instrumental in overcoming development and manufacturing challenges and achieving a competitive advantage in the market with streamlined manufacturing processes.

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LogiPharma Europe 2024: UPS Healthcare VP of Sales Talks Technology and Sustainability

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses current technology that the pharma industry is adopting when it comes to sustainability.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Specifying a tumble blender for pharmaceutical manufacturing

PharmaTech

Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.

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A Biosimilars Roadmap: Understanding Payer Perceptions

PharmExec

With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount.

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Mixing Technologies in the Pharmaceutical and Medical Industries (May 2024)

PharmaTech

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications

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Aardvark Therapeutics Completes $85 Million Oversubscribed Series C Round of Funding, Aiming to Advance ARD-101 for Hyperphagia in Patients with Prader-Willi Syndrome

PharmExec

Led by Decheng Capital, the successful round of funding also included participation from investors such as Cormorant Asset Management, Surveyor Capital, and the Foundation for Prader-Willi Research.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.