Tue.Sep 17, 2024

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J&J talc appeal upends $260M award to Oregon woman with mesothelioma

Fierce Pharma

Three months after a jury awarded $260 million to an Oregon woman who claimed | Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

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Providers and Payers Are Increasing Their Tech Spend — Where Are They Investing the Most?

MedCity News

Three-quarters of U.S. providers and payers say they have increased their IT spending over the past year, according to a new report from Bain & Company and KLAS Research. Both providers and payers are investing in cybersecurity technology, as well as AI tools. The post Providers and Payers Are Increasing Their Tech Spend — Where Are They Investing the Most?

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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

Fierce Pharma

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

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FDA clears sleep apnoea feature for new Apple Watch

pharmaphorum

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.

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

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CDMO Serán snags $200M Bain-led investment to build its first commercial facility

Fierce Pharma

With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its cust | With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its customers.

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Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating Drug

MedCity News

Nura Bio aims to treat neurodegeneration with a small molecule designed to block SARM1, a novel target involved in axon degeneration. Following positive Phase 1 results in healthy volunteers, the startup is now preparing for mid-stage clinical testing. The post Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating Drug appeared first on MedCity News.

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Brightside Health Launches Mental Health Services for Teens

MedCity News

Brightside Health is expanding to serve teens ages 13 to 17. These teens can receive therapy and psychiatry services and will eventually have access to the company’s Crisis Care support. The post Brightside Health Launches Mental Health Services for Teens appeared first on MedCity News.

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Ori doubles down on Charles River collaboration with promising new data on its automated cell therapy platform

Fierce Pharma

Just a few months after the reveal of Ori Biotech’s automated cell and gene therapy manufacturing platform IRO, the technical expert is doubling down with one of its chief allies. | Ori unveiled a collaboration with influential CDMO Charles River Laboratories to showcase the benefits of its next-generation cell therapy production platform. Specifically, the companies are showcasing new biological data from IRO comparing the Ori system to a process specifically optimized by Charles River for CAR-

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From Silos to Synergy: Integrating Clinical Teams into Agile Product Workflows

MedCity News

Whether creating a health application or platform-based solutions, the effectiveness of innovation in healthtech relies not only on scientifically backed up technology, but more on consumer-driven design, highlighting the need for precision and efficiency. The post From Silos to Synergy: Integrating Clinical Teams into Agile Product Workflows appeared first on MedCity News.

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After FDA no, MSD/Daiichi post new data with lung cancer ADC

pharmaphorum

MSD and Daiichi Sankyo's patritumab deruxtecan hit its main objective in a phase 3 lung cancer study that reinforces its potential as a new treatment option for patients after first-line treatment with EGFR inhibitors.The HERTHENA-Lung02 study in EGFR-mutated non-small cell lung cancer (NSCLC), involving patients with locally advanced or metastatic disease previously treated with EGFR drugs, revealed a significant improvement in progression-free survival (PFS) compared to a chemotherapy regimen.

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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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Doubling Down on Falls: How Technology is Redefining Fall Prevention

MedCity News

Integrating comprehensive risk assessment tools that identify fall risks early can enable healthcare providers to implement personalized preventive measures, such as tailored exercise and physical therapy programs that strengthen mobility and balance among at-risk individuals. The post Doubling Down on Falls: How Technology is Redefining Fall Prevention appeared first on MedCity News.

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Trial sets up filings for Boehringer IPF drug nerandolimast

pharmaphorum

Boehringer will file its idiopathic pulmonary fibrosis drug nerandolimast next year, a successor to its blockbuster Ofev, after a phase 3 win

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FDA grants RMAT to Poseida’s CAR-T cell therapy P-BCMA-ALLO1

Pharmaceutical Technology

Poseida Therapeutics has received RMAT designation from the US FDA for its CAR-T cell therapy, P-BCMA-ALLO1.

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Trial sets up filings for Boehringer IPF drug nerandomilast

pharmaphorum

Boehringer will file its idiopathic pulmonary fibrosis drug nerandolimast next year, a successor to its blockbuster Ofev, after a phase 3 win.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UKRI’s MRC awards £27.4m to University of Dundee research unit

PharmaTimes

The centre aims to discover new drug targets for diseases such as Parkinson’s and hypertension

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Recipharm Investment Will Enhance Oral Solid Development, GMP Pilot-Scale Suites

PharmaTech

The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.

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Elyse Blazevich on Driving Innovation in Colorado's Thriving Life Sciences Ecosystem

PharmExec

Elyse Blazevich discusses the Colorado Biosciences Association’s efforts to support the state’s life sciences sector by fostering partnerships, advocating for industry growth, and building a diverse talent pipeline.

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CCC Introduces RightFind Curriculum to Simplify the Use of High-Quality Copyrighted Content in K-12 Curriculum

Copyright Clearance Center

September 17, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced the launch of RightFind Curriculum , the only all-in-one combined content and licensing solution that enables K-12 educators, EdTech companies, curriculum developers, and custom publishing companies to easily search for, discover, and incorporate high-quality, copyrighted content into curriculum and instructional materials, EdTech applications, and online

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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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Jan van de Winkel: Antibody Ascension

PharmExec

Jan van de Winkel, PhD, president and CEO of Genmab, the longtime innovation engine in antibody drug development, discusses its vision for adding a new business identity: commercial driver.

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Biotech financing’s rebound: How high will it go?

Clarivate

The biotech industry has experienced a rollercoaster of financing and dealmaking trends over the past few years. From the record-breaking heights of the COVID-19 era to the recent slowdown in 2023, signs of resilience and recovery are beginning to emerge. In the first half of 2024, the biotech industry is witnessing early signs of a rebound in financing and dealmaking activities.

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How Do Drug Shortages Affect Pharmacovigilance?

Pharmaceutical Commerce

Drug shortages, including critical antibiotics, fever medications, and cancer treatments, highlight global supply chain issues and the need for improved health policies to prevent medication bottlenecks.

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Industry Leader Julie Adrian Appointed by FINN Partners to Accelerate Growth of Agency’s UK Health Group

PM360

Embargoed until Tues., Sept 17 at 8AM ET. Industry Leader Julie Adrian Appointed by FINN Partners to Accelerate Growth of Agency’s UK Health Group Appointment Underscores Agency’s Commitment to Building Global Health Business London and New York, Sept. 17, 2024 – FINN Partners, one of the world’s leading independent marketing and communications agencies, today announces the appointment of Julie Adrian as Managing Partner and UK Health Group Lead.

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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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True Digital Surgery Appoints Kevin T. Foley as Chief Medical Officer

PharmExec

As chief medical officer, Foley is expected to guide the clinical direction of True Digital Surgery and the advancement of its Digital Surgical Exoscope Platform.

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How a radiopharma up-and-comer builds momentum in a surging space

PharmaVoice

Big Pharma is embracing the radiopharmaceuticals boom that was a long time in the making.

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FDA lifts partial clinical hold on Zentalis Pharma’s cancer WEE1 inhibitor  

Pharmaceutical Technology

The clinical hold was placed on three studies investigating azenosertib in June after two patients died due to presumed sepsis.

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A Care Sea Change

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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MaxCyte and Kamau Therapeutics sign platform license agreement

Pharmaceutical Technology

MaxCyte has entered into a license agreement with Kamau Therapeutics, a clinical-stage company focused on stem cell therapy gene correction.

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Pharmaceutical Executive: September 2024 Issue (PDF)

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Korro Bio and Novo Nordisk Collaborate on Cardiometabolic Treatments

PharmaTech

Novo Nordisk will use Korro Bio’s OPERA platform to develop RNA editing candidates for two targets to treat cardiometabolic diseases.

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Biotech Performance Pivot May Be in the Offing

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.