Fri.Dec 01, 2023

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J&J, AbbVie, Sanofi and many other companies face competition probe in Turkey

Fierce Pharma

Turkish authorities have launched an investigation into 19 pharmaceutical companies to probe whether their operations violated the country’s competition law, the Turkish Competition Authority discl | The companies, which include Pfizer, J&J, Sanofi, AbbVie, AstraZeneca, Merck and others are being probed for potentially violating Turkish competition law, according to a release from the country's government.

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Nvidia Launches Cloud-Based APIs to Accelerate AI Deployment in Medical Imaging

MedCity News

At RSNA 2023, Nvidia launched new set of cloud-based APIs designed to speed up the creation and deployment of specialized AI models in the medical imaging field. The new offering is a cloud-native extension to Nvidia’s Monai framework, which is its open-source framework for medical imaging AI.

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AstraZeneca calls it quits on pair of trials for hyperkalemia drug it scored in buyout of ZS Pharma

Fierce Pharma

After a hard-fought battle for FDA approval, AstraZeneca has hit another setback on its quest to turn its potassium-reduction drug Lokelma into a blockbuster. | AstraZeneca has put the kibosh on two late-stage Lokelma trials testing the hyperkalemia drug in patients with heart and kidney diseases. The studies were called off due to “substantially increased enrollment times and low event rates,” AZ said Friday.

Pharma 222
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PCORI Pours $80.5M Into Research On Maternal Health Inequities

MedCity News

The Patient-Centered Outcomes Research Institute announced that it is funding four studies focused on reducing maternal health inequities. The studies all leverage partnerships with community organizations.

Patients 121
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Texas AG Paxton fires off another lawsuit at Pfizer, this one over the company's COVID-19 vaccine

Fierce Pharma

Texas attorney general Ken Paxton is going after Pfizer—again. | Texas attorney general Ken Paxton is going after Pfizer—again. Less than two weeks after documents were unsealed showing that Texas has accused Pfizer and manufacturer Tris Pharma of providing a compromised ADHD medicine to the state, Paxton has sued Pfizer for “unlawfully misrepresenting the effectiveness” of the company’s COVID-19 vaccine.

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Don’t Get Distracted By AI, Instead Focus on Intellectual Property

PharmExec

Artificial intelligence is making it quicker to get drug candidates to the clinic, but it isn’t addressing the fundamental need to marry the right candidate and the right target to the right disease.

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FDA Priority Review Granted to Keytruda/Padcev Combo for Locally Advanced, Metastatic Urothelial Carcinoma

Pharmaceutical Commerce

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

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Patients Should Be at the Center of Pharmacy Care. Why Aren’t They?

MedCity News

We should strive for a future where patients have easy and affordable access to medications, supported on their journey by trusted pharmacy professionals who are an integral part of their care team.

Patients 105
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AbbVie agrees $10 billion oncology acquisition

European Pharmaceutical Review

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 billion. The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease. As a folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor, the biologic medicine offers expansion opportunities in e

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Enterprise Knowledge: A Unifying Technological Vision for the Future of Radiology

MedCity News

Laying AI functions on top of already outdated systems or relying on separate solutions that do not play into the unified stack system––especially given the volume of data, delicate privacy issues and the need for constant updates––does not optimally contribute to the advancement of radiology.

Medical 105
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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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Maximizing Dental Practice Efficiency and Attracting Patients: Software and Marketing Tips

Referral MD

Managing dental referrals can be tedious, involving phone calls, emails, and endless paperwork. Dental referral software offers a comprehensive solution by digitizing the entire process. You can send and receive referrals, track their progress, and easily communicate with other dental practices with just a few clicks. Say goodbye to lost referrals and hello to a more organized and efficient workflow!

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How to Improve Coding Quality to Prevent Denials, Reduce Payer Takebacks, and Improve Cash Flow

MedCity News

Practices should take a fresh look at their coding quality, which can help reduce denials, payer takebacks, and cash flow issues. Implementing intensive coding training, CAC technology, and internal audit and review programs can help. However, for practices that lack the resources to make such investments, outsourcing may be a better approach.

Training 104
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Challenging applications of capillary electrophoresis in biopharmaceutical analysis

European Pharmaceutical Review

Since its introduction in 1980, capillary electrophoresis (CE) has been one of the most powerful techniques applicable as a choice method in the biopharmaceutical industry for the characterisation and quality control (QC) testing of biomolecules such as proteins, peptides as well as monoclonal antibodies (mAbs) and high molecular weight polysaccharides. 1 In addition to the intrinsic advantages of CE, such as high separation efficiency, high resolution, low sample volume requirements, short sepa

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Navigating the New Era of Organ Transplantation: Key Areas of Success

MedCity News

As a heart transplant recipient less than three years out from quadruple organ failure, and a father of two young children, I’m not just hoping that modernization will save and extend more lives. I’m counting on it.

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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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Orchard secures FDA fast track designation for Hurler syndrome gene therapy

Pharmaceutical Technology

Hot on the heels of the designation, Orchard Therapeutics is pressing ahead with a multi-centre trial for the candidate with a start date in December.

FDA 98
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Optimizing the Public Health Workforce Amidst Continuous Friction

MedCity News

It is only by supporting the public health workers, and making their jobs more appealing that health agencies can strengthen the workforce to prevent and respond to future public health threats.

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Cannes Lions, Ad Forum Spotlight The Chrysalis Initiative & EVERSANA Intouch in New Webinar, Article

Eversana Intouch

Recently, Ad Forum published an article highlighting five campaigns it found to be “ Raising the Bar for Health Equity in Advertising.” One was our ongoing work with The Chrysalis Initiative, a nonprofit working to eliminate racial disparities in breast cancer treatment. This alliance dates back to 2021, but in 2023, as Fierce Pharma put it, we “ roared back from rejection to craft a Cannes-winning campaign hospitals couldn’t ignore.

Pharma 87
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Survey reports on falsification of medical devices

European Pharmaceutical Review

A new report by the Committee of Experts on minimising the public health risks posed by falsified medical products and related crimes (CD-P-PH/CMED) shares insight on how authorities perceive and address the falsification of medical devices. The report details findings from survey completed by 21 of the 46 Council of Europe member states on counterfeit medical devices.

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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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AstraZeneca’s durvalumab recommended for bile duct cancers

Pharmaceutical Technology

The SMC and NICE have recommended the use of AstraZeneca’s durvalumab to treat advanced biliary tract cancers in England and Scotland.

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Drug development trends: insight from Thermo Fisher’s Anil Kane

European Pharmaceutical Review

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. Dr Kane leads a team of subject matter experts at Thermo Fisher, covering drug products in both sterile injectable dosage and oral solid dosage forms.

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Prostate cancer focal therapy could improve costs and patient outcomes

PharmaTimes

Every year, over 44,000 men are diagnosed with prostate cancer in England - News - PharmaTimes

Patients 112
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AZ drops two trials aimed at expanding Lokelma’s label

pharmaphorum

AstraZeneca has decided to abandon two phase 3 trials of its drug to reduce high levels of potassium in the blood (hyperkalaemia) – Lokelma – in patients with kidney disease. The STABILIZE-CKD and DIALIZE-Outcomes studies – part of AZ’s CRYSTALIZE programme for the drug – have been shelved because patients were being enrolled into them more slowly than hoped for, and clinical events were occurring at a lower rate than expected.

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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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Biocon integrates Viatris biosimilars in 31 European countries

Pharmaceutical Technology

Biocon subsidiary Biocon Biologics has successfully integrated Viatris' biosimilars business in 31 countries in Europe.

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‘Constitutional Collisions’ Come Back to Haunt Dobbs Decision

MedCity News

Opposing sides are girding for a likely momentous constitutional confrontation.

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Partnership deals for psychedelic drugs take a trip with 500% surge in 2023

Pharmaceutical Technology

Partnership deals involving psychedelic drugs saw a 500% growth in total deal volume from 2019 to 2023 year-to-date (YTD).

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Radiotherapy boost shown to reduce treatment times for breast cancer patients

PharmaTimes

Every year, around 55,000 women in the UK are diagnosed with the condition - News - PharmaTimes

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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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Keys to Success for Social Media in Healthcare Advertising

PharmExec

How to build a loyal audience of brand evangelists.

Media 115
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Digital Medicine Conference You Don’t Want to Miss [Sponsored]

MedCity News

NODE.Health 7th annual conference. December 6-8, 2023, Microsoft NYC, New York.

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FDA Grants Priority Review to Keytruda Plus Padcev for Urothelial Carcinoma

PharmExec

The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

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FDA starts review of Padcev/Keytruda for bladder cancer

pharmaphorum

FDA starts review of Padcev/Keytruda for bladder cancer Phil.

FDA 95
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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.