Tue.Oct 10, 2023

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Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

Fierce Pharma

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Ke | What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda.

Doctors 294
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Sanofi Adds Biologics to Its AI Ambitions, Striking Up R&D Alliance With BioMap

MedCity News

Formed by Baidu founder and CEO Robin Li, BioMap uses artificial intelligence technology to glean insight into proteins to guide biologic drug discovery. The startup is the latest company to join a growing list of Sanofi partners as the pharmaceutical giant continues investing in AI-enabled drug discovery.

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Bayer christens $250M cell therapy 'launch facility' in Berkeley

Fierce Pharma

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. | Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.

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CCC Releases AI-Enabled Affiliation Matching Software Powering Open Access Publication Modeling and Analysis for Publishers

Copyright Clearance Center

October 10, 2023 – Danvers, Mass. – CCC , the leading provider of Open Access (OA) workflow solutions, announces new data import capabilities and AI-enabled affiliation matching in its OA Agreement Intelligence modeling and analytics tool that provides publishers with a 360-degree view of disambiguated publication data to build accurate, transparent institutional offers regarding OA.

Training 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Point of Care Personalization: A Conversation with Veradigm

Fierce Pharma

Personalization—we’re all talking about it, and we’re all trying to do it better. So what sets Veradigm apart? | Veradigm has insights as to how personalized and targeted messaging can drive awareness and engagement, ultimately improving the patient experience.

Patients 225
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Why One Expert Thinks the Medicare Drug Price Negotiation Program Is Here to Stay

MedCity News

Merith Basey, executive director of Patients For Affordable Drugs, believes the Medicare price negotiation program is here to stay, no matter who is president and no matter how many Big Pharma players file lawsuits. Her reasoning? Every other high income nation has been negotiating prices with drugmakers for years, and the program is widely popular in the U.S. among pretty much everyone who isn’t a pharma company, she said during a session at Engage at HLTH.

Pharma 111

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Bayer’s New $250M Cell & Gene Therapy Site Signals More Investments to Come

MedCity News

Bayer opens its new cell therapy manufacturing facility as it prepares a Parkinson’s disease cell therapy for Phase 2 testing. The new 100,000 square foot facility also has space for manufacturing other cell therapies in the pharma giant’s pipeline.

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Amid Eylea showdown, Roche's Vabysmo shows durability in retinal vein occlusion

Fierce Pharma

Roche has presented data that show Vabysmo can maintain visual gains in RVO with a dosing duration stretched to as long as once every four months.

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Bessemer Venture Partners Unveils State of Health Tech Report at HLTH 2023 [Sponsored]

MedCity News

The report maps out the health tech sector’s current position in the innovation hype cycle, which business models are most resilient, and how the industry can move out of the trough of disillusionment. It also offered predictions for health tech trends in 2024.

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Life Sciences Innovation Day – Accelerating Digital Transformation Ambition

European Pharmaceutical Review

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition. Set at the world-renowned Silverstone F1 Racetrack on 18 October 2023, it promises to be a day of immersive insights and top rate networking.

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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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Highmark Health, Spring Health Team Up for Mental Health Solution

MedCity News

Spring Health and Highmark Health are collaborating to launch Mental Well-Being, a solution that offers therapy, medication and other services for some Highmark members.

Medical 105
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How commercial employer plans and coverage matter for orphan drugs

Pharmaceutical Technology

In a two-part column, F. Randy Vogenberg delves into why it is important to address emerging challenges in the employer-based US commercial insurance landscape.

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Main Street Health Rakes In $315M to Scale Value-Based Care in Rural America

MedCity News

Main Street Health announced the close of a $315 funding round at HLTH — some of the investors included UnitedHealthcare, Humana, Elevance, Centene and CVS. The startup, which scales value-based care in rural areas for both Medicare Advantage and original Medicare patients, also announced that it is expanding to 26 states.

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ECNP 2023: new esketamine NS safety data for depression

European Pharmaceutical Review

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD). This treatment is an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor.

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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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Move Over, White Whales – Zebras Are Here

Eversana Intouch

Fact 1: Pharma is in the business of discovering, developing, and producing drugs with the aim of treating, curing, or preventing diseases…ultimately leading to healthier communities around the world. Fact 2: Pharma is just that – a business. Both facts are true. Both facts co-exist. And both facts impact how society views our industry. On that last point, there have clearly been times where Fact 2 has a direct influence on Fact 1.

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UKRI awards £41m to enhance UK research and innovation

PharmaTimes

The scheme will help ten projects establish research and innovation clusters - News - PharmaTimes

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Research in space yields clues about boosting bone health on Earth

PharmaVoice

A study aimed at helping astronauts decrease bone loss could open the door to novel osteoporosis meds.

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Talking AI at Frankfurt: A Look at Some of the Programming Ahead

Copyright Clearance Center

The upcoming Frankfurter Buchmesse has programming looking at many aspects of artificial intelligence and related issues…

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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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Gates Foundation announces $40m for mRNA vaccine platform

Pharmaceutical Technology

The Gates Foundation is providing $40m in funding to advance the accessibility of Quantoom Biosciences' affordable mRNA vaccine platform.

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Study reveals diagnosis and treatment inequalities in NHS heart care

PharmaTimes

Researchers focused on four of the most common heart conditions in the UK - News - PharmaTimes

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LogiPharma USA 2023: Sea vs Air – Identifying Ways to Make International Cold Shipping Efficient and Sustainable

Pharmaceutical Commerce

Session offers insight on how to successfully implement cold chain transport.

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Building a Robust Provider Network with SDoH Insights

Clarify Health

Social determinants of health (SDoH) play a significant role in the overall health and well-being of individuals and communities. When building provider networks, it is crucial to include providers who can assess and address social determinants to ensure that care is equitable, patient-centered, and effective in improving health outcomes and reducing healthcare disparities.

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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.

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Bayer Opens $250M Cell Therapy Manufacturing Facility

PharmExec

Site aims to advance regenerative medicines on a global scale.

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Optimizing Highly Potent API Drug Development and Manufacturing

PharmaTech

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. Learn more about creating a safe, efficient and scalable drug development program with HPAPIs in this eBook.

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FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System

Legacy MEDSearch

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System. Hammerdesis allows surgeons to correct hammertoe deformities and degenerative issues in patients by simply affixing a distinctively designed implant on the patient’s toe joint.

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Project Management: The Secret Weapon in Effective Tech Transfer

PharmaTech

Central to a successful technology transfer is effective project management. This white paper discusses the role of project management at Jubilant HollisterStier in creating and executing transfer plans and the innovative solutions developed for the transfer of five COVID-19 vaccine and therapeutic fill finish manufacturing projects.

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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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Could greater adoption of remote nursing visits lead to faster study results?

Pharmaceutical Technology

As sponsors seek to minimize trial delays and get new therapies to market faster, we explore whether increased adoption of a more patient-centric approach could make a difference to timelines.

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CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)

PharmaTech

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

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Bayer backs cell therapy ambition with $250m US facility

pharmaphorum

Bayer backs cell therapy ambition with $250m US facility Phil.

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ABVC BioPharma obtains patent for MDD treatment in Taiwan

Pharmaceutical Technology

ABVC BioPharma has obtained a patent in Taiwan for the usage of PDC-1421 in ABV-1504, an asset intended for major depressive disorder.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.