Thu.Dec 21, 2023

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2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it

Fierce Pharma

Big Pharma companies have often talked about the major opportunities that await in China. | Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country.

Pharma 261
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Arcadia Sells Its Value-Based Care Division to a Fledgling Startup

MedCity News

Guidehealth, a nascent value-based care enablement startup, acquired Arcadia’s value-based care service division. Acquiring this business unit allows Guidehealth to provide health systems with a platform that helps them succeed in value-based care arrangements while still maintaining their patient volume levels.

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Trending Sources

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As Vertex and CRISPR build out Casgevy launch, doctor sees strong demand and warns of possible supply hitches

Fierce Pharma

As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their CRISPR-based gene-editing therapy Casgevy, one doctor who treats sickle cell disease patients is already | As Vertex Pharmaceuticals and CRISPR Therapeutics lay the groundwork for the launch of their world-first CRISPR-based gene therapy Casgevy, one doctor who treats sickle cell disease patients is already seeing strong demand.

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Report: Lower-Income Adults With Employer Coverage More Likely To Experience Challenges than Higher-Income Adults

MedCity News

Of those with employer-sponsored insurance, 31% of lower-income adults reported having trouble paying their medical bills, versus 13% of higher-income adults, according to a new report from KFF.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Court reverses Servier verdict on Mediator, ?orders payment of €430M

Fierce Pharma

Two years ago, with a favorable ruling and a slap-on-the | A favorable ruling two years ago had Servier hoping that its decades-long litigation surrounding weight-loss pill Mediator was finally over. But an appeal from prosecutors now leaves the company facing a hefty penalty.

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The AI Tool that Matters Most for Clinical Care Isn’t ChatGPT

MedCity News

Right-now value could come from extractive AI, a tool that gives organizations the power to put even handwritten text sent via images or PDF by digital fax into a structured data play.

More Trending

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Knownwell Secures $20M for Weight-Inclusive Primary Care

MedCity News

Knownwell’s $20 million Series A funding round was led by A16Z and included participation from Flare Capital Partners. The company also launched an adolescent metabolic health program.

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With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

Fierce Pharma

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. | The approval in hereditary transthyretin-mediated amyloid polyneuropathy, which affects around 40,000 to 50,000 patients globally, sets the stage for a potential label expansion down the line to treat the broader transthyretin amyloid cardiomyopathy patient population.

FDA 203
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The PBM Model of the Future: Why Payers Are Unbundling PBM Services [Sponsored]

MedCity News

Javier Gonzalez, Chief Growth and Commercial Officer at Abarca, about why payers are increasingly looking for alternatives to the traditional PBM model.

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GSK, Amneal and Kaleo pull patents from FDA database after FTC challenge

Fierce Pharma

Following the U.S. | Following the U.S. Federal Trade Commission's recent crackdown on "improper" patents in the FDA's Orange Book, GSK, Amneal and Kaleo have made the requested changes.

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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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CDMO expands ADC facility in Scotland

European Pharmaceutical Review

Piramal Pharma Solutions has officially opened new facilities at its antibody-drug conjugate (ADC) manufacturing facility in Grangemouth, Scotland. This expansion enhances the site’s capacity by 70-80 percent and will enable scale-up of commercial ADC manufacturing batches. “The global ADC market is growing strongly and so is the pipeline at Grangemouth, necessitating additional capacity to meet customer demand,” said Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions.

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Genevoyager opens CDMO facility for gene therapy development

Pharmaceutical Technology

Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.

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NICE recommends combination therapy for prostate cancer

European Pharmaceutical Review

The UK’s National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. This NICE recommendation is based on data from the PROpel Phase III clinical trial, which enrolled 700 patients globally.

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Let’s Talk Prostate Cancer calls for action by MEPs

pharmaphorum

An organisation representing the interests of patients with prostate cancer has published a manifesto ahead of the EU elections next year, calling for more screening for the disease in EU member states.

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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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Wearable technology to be offered to thousands with type 1 diabetes in UK

PharmaTimes

The condition affects around 270,935 people in England and 16,090 people in Wales - News - PharmaTimes

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Sanofi drops lung cancer ADC tusamitamab ravtansine

pharmaphorum

Sanofi ends development of CEACAM5-targeting ADC tusamitamab ravtansine after it fails a phase 3 trial in non-small cell lung cancer (NSCLC)

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Wearable technology to be offered to thousands with type 1 diabetes in UK

PharmaTimes

The National Institute for Health and Care Excellence (NICE) has published final guidance announcing a five-year roll-out of a wearable technology for patients living with type 1 diabetes. The new hybrid closed loop systems have proven to be more effective in maintaining healthy blood glucose levels than standard care. The new guidance followed a review of a clinical trial and real-world evidence by the University of Warwick and Warwick Medical School, funded by the National Institute for Health

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NICE backs digital technologies for COPD rehab

pharmaphorum

NICE backs NHS use of digital COPD rehab programmes, myCOPD and SPACE for COPD, as an alternative to face-to-face consultations

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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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NHS expands home-testing kits to detect bowel cancer earlier

PharmaTimes

Bowel cancer is currently the third most common type of cancer in England - News - PharmaTimes

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AI specialist Fauna grabs $494m Lilly obesity alliance

pharmaphorum

Lilly partners with Fauna Bio in $494m deal to see if a hibernating squirrel's genomics could unlock new obesity drug targets.

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NHS expands home-testing kits to detect bowel cancer earlier

PharmaTimes

The NHS has announced the expansion of its home-testing kits for bowel cancer in an effort to detect signs of the disease and diagnose it earlier. The expansion of the NHS Bowel Cancer Screening Programme aligns with the health service’s aim of detecting cancers at an earlier stage when they are easier to treat. Currently the third most common type of cancer in England and responsible for almost 43,000 new cases in the UK every year, bowel cancer starts in the large bowel (colon) and the back pa

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Indivior bags $111m contract from US for overdose therapy

pharmaphorum

Indivior has secured a $111 million BARDA supply contract in the US for its Opvee intranasal therapy for treating opioid overdose

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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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Celebrating women in IP: Meet our expert Milena Dimic

Clarivate

In light of this year’s World Intellectual Property Day, “Women and IP: Accelerating innovation and creativity”, Clarivate TM is proud to highlight the contributions of women IP experts to our mission. As a company, we strive to help companies accelerate innovation, achieve long-term growth, and realize sustainable success. Our women IP experts are an invaluable part of our trajectory.

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FDA holds back MSD’s chronic cough drug again

pharmaphorum

FDA issues a second complete response letter to MSD's gefapixant for chronic cough, giving GSK a chance to catch up with camlipixant

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FDA Publishes Guidance on Real-Word Data

PharmaTech

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

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Servier facing €431m penalties in new Mediator judgment

pharmaphorum

Servier has been found guilty of fraud and deception over weight loss therapy Mediator by French appeals court, and is fined €431 million

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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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Navigating the Complexities of Medical Staff Recruitment: A Comprehensive Guide

Rep-Lite

If you’re in charge of hiring medical staff, you know how complex and challenging it can be to find the right candidates. Whether you’re trying to fill a small clinic or a large hospital, medical staff recruitment requires a comprehensive strategy addressing many factors. In this guide, we’ll explore the ins and outs of medical staff recruitment, from identifying your needs to sourcing candidates and making successful hires.

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The Role of Pharmacists in HIV Care Continues to Expand

Pharmacy Times

Pharmacists play a vital role in HIV care by addressing social determinants of health, managing complex HIV medication regimens, and providing comprehensive patient counseling.

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MEI Pharma files patent for a cancer treatment method using mitochondrial and bcl-2 inhibitors

Pharmaceutical Technology

Discover a groundbreaking method to treat cancer using a combination of mitochondrial and Bcl-2 inhibitors. Learn more about this patent's innovative approach.

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Biopharma’s FTC headache deepens with guideline shifts years in the making

PharmaVoice

Closer scrutiny of pharma deals has made the M&A landscape trickier as a new approach seeks to expand the competitive arena.

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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.