Thu.Sep 05, 2024

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AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg

Fierce Pharma

AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.

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Digital Transformation in Healthcare: Mastering Efficiency and Innovation

Pharma IQ

Explore how digital transformation, particularly cloud technology and AI enhances efficiency and patient outcomes.

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J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis

Fierce Pharma

Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better chall | Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challenge AstraZeneca’s Tagrisso.

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The Life Sciences Generative AI Council and a sustainable technological future

pharmaphorum

Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.

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

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Cash-crunched ImmunityBio, on heels of FDA nod for Anktiva, lays off staffers

Fierce Pharma

With dwindling funds after a prior snub from the FDA, ImmunityBio’s journey to bag approval for its Merck-rivaling bladder cancer drug Anktiva wasn’t easy. | The drugmaker laid off 20 employees as it attempts to recoup from dwindling funds during its Anktiva launch in bladder cancer.

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China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

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Samsung Acquires AI-Powered Prenatal Ultrasound Startup

MedCity News

Samsung announced its plans to acquire French medtech startup Sonio. The startup’s AI platform, which was cleared by the FDA last year, automates ultrasound reporting so that healthcare providers can conduct these exams with greater accuracy and efficiency. The post Samsung Acquires AI-Powered Prenatal Ultrasound Startup appeared first on MedCity News.

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BIOSECURE Act heads for possible vote in House of Representatives next week

Fierce Pharma

After running up against a roadblock earlier this summer, the controversial BIOSECURE Act could gain new momentum next week. | Next week, the U.S. House of Representatives is slated to consider the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with certain Chinese biotech equipment and service providers over national security concerns.

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What Challenges Do Implementing New Tech at a Hospital Pose?

MedCity News

Cyril Philip, vice president of digital health ventures with Bon Secours Mercy Health and digital ventures lead for Accrete Health Partners, is taking part in a panel discussion at INVEST Digital Health in Dallas on September 18. In response to emailed questions, he addressed some of these challenges. The post What Challenges Do Implementing New Tech at a Hospital Pose?

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Sneak Preview of PDA Universe of Pre-Filled Syringes and Injection Devices Conference

Fierce Pharma

Insights from Planning Committee Member Shirish Ingawale | Why is PDA’s Universe of Pre-Filled Syringes and Injection Devices Conference the must-attend event of the year? Get an exclusive preview from expert Shirish Ingawale!

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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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What Do Consumers and AI Think Of Omada Health?

MedCity News

Omada Health is a respected health tech company but what do customers see it? A flesh and blood and an AI analysis follows. The post What Do Consumers and AI Think Of Omada Health? appeared first on MedCity News.

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With $1.1B pot sweetener, Johnson & Johnson gets one step closer in Texas two-step talc plan: Reuters

Fierce Pharma

By adding $1.1 billion to its settlement proposal, Johnson & Johnson is inching closer to resolving approximately 62,000 personal injury lawsuits from those who claim their cancers were caused | By adding $1.1 billion to its settlement proposal, Johnson & Johnson is inching closer to resolving approximately 62,000 personal injury lawsuits from those who claim their cancers were caused by the company’s talcum powder products.

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HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

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This Diagnostic Startup Uses Saliva to Detect Oral Diseases Earlier

MedCity News

Dr. Tina Saw is the founder and CEO of Oral Genome, a healthcare startup that’s developing saliva tests to detect and prevent oral diseases. In response to emailed questions, Saw talked about her company’s approach. The post This Diagnostic Startup Uses Saliva to Detect Oral Diseases Earlier appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Trial of Click's DTx for migraine sets up FDA filing

pharmaphorum

Click Therapeutics' digital therapeutic for migraine clears late-stage study using an endpoint used to test drugs, clearing the way for regulatory filing.

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Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative

MedCity News

Positive preliminary results for Eli Lilly’s efsitora alfa continue to build the case for this once-weekly insulin in type 2 diabetes patients. Lilly is trying to catch up to Novo Nordisk’s once weekly insulin icodec, which is commercially available in several markets around the world but is not yet approved by the FDA. The post Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative appeared first on MedCity News.

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J&J sweetens controversial talc settlement deal

pharmaphorum

J&J is reported to have raised its offer to settle claims that its talc products caused cancer by $1.1bn, as it reaches agreement with a holdout law firm.

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Three Critical Steps to Ensure Health Plans’ Smooth Transition of Transportation Management Services

MedCity News

Switching to a new transportation management vendor can bring much-needed relief to member populations and plan staff managing the programs. Here are few tips to help make the transition easier. The post Three Critical Steps to Ensure Health Plans’ Smooth Transition of Transportation Management Services appeared first on MedCity News.

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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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Advanz wins stay on EU revocation of Ocaliva license

pharmaphorum

EU General Court suspends decision to revoke the license for Advanz Pharma's primary biliary cholangitis drug Ocaliva.

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While America Rested on Labor Day, The Invisible Healthcare Workforce Carried On

MedCity News

Let’s envision a healthcare system where caregiving is valued as the essential work it is. Where technology and policy work hand in hand and no one has to choose between caring for a loved one and pursuing their own health and career goals. The post While America Rested on Labor Day, The Invisible Healthcare Workforce Carried On appeared first on MedCity News.

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Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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SEQSTER, PatientsLikeMe Launch Patient Data Partnership

MedCity News

Through a new partnership announced Thursday, SEQSTER will be PatientsLikeMe’s electronic health record provider. The post SEQSTER, PatientsLikeMe Launch Patient Data Partnership appeared first on MedCity News.

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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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Lilly and EVA Pharma to expand baricitinib access in Africa

Pharmaceutical Technology

Eli Lilly and EVA Pharma have formed a partnership to increase the availability of baricitinib in 49 African countries by 2030.

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ArsenalBio raises $325m for programmable CAR-T platform

pharmaphorum

ArsenalBio raises $325m for programmable CAR-T platform Phil.

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Lilly partners with Haya for lncRNA obesity target deal worth $1bn

Pharmaceutical Technology

Haya could secure up to $1bn after hitting preclinical, clinical, and commercial milestones with drugs that emerge from this deal.

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European Commission grants orphan drug designation for Vivet’s VTX-806

PharmaTimes

Pre-clinical data of VTX-806 in demonstrated normalisation of metabolic parameters

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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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Moderna mpox mRNA vaccine shows early promise in monkey study

Pharmaceutical Technology

Moderna is currently running a Phase I/II trial of the mRNA mpox vaccine mRNA-1769 in healthy participants.

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It’s All About the Small Things

PharmaTech

Qualifying material suppliers is a crucial step in ensuring safe and effective drug products.

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Advancing NOX inhibitors for treating fibrotic diseases and cancer

European Pharmaceutical Review

Reactive oxygen species (ROS) are unstable molecules that react with other molecules in a cell and can damage DNA, RNA and proteins. NADPH oxidases (NOX) are a group of enzymes responsible for producing ROS, the production of which is linked with inflammation and fibrotic conditions. There is speculation that reducing levels of ROS could help find treatments for a range of diseases including cancer as well as inflammatory and fibrotic diseases.

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Behind the Headlines: Weight Loss Drugs; Price Controls; and Free COVID Therapies

PharmaTech

This Behind the Headlines news roundup panel discussion covers news items such as the weight loss drugs battle between Novo Nordisk and Eli Lilly, entering new territory through Lilly’s partnership with HAYA Therapeutics and long non-coding sequence mining. There was much discussion on how the inflation reduction act and Medicare price controls may or may not pertain—given the uncertainty around the presidential election results, and subsequent policy directions.

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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.