Sun.Jul 02, 2023

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Medical Expenses Will Rise by 7% Next Year, Report Predicts

MedCity News

New research predicts that healthcare costs will increase by 7% next year. The estimate is higher than the projected medical cost trends in 2022 and 2023 — which were 5.5% and 6.0%, respectively.

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Automation Aids Cell and Gene Therapy Production

PharmaTech

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

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Hospitals and Health Systems Realize Growth Advantage of a Specialty Pharmacy Partnership

MedCity News

Implementing a specialty pharmacy strategy and approach for growth not only creates a revenue stream for the system, but also establishes a high-touch patient engagement program that becomes a differentiator in the way service is delivered for their community.

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Marketing in the AI Age

PharmExec

Here in New Jersey, our home base, summer is officially upon us, and the Canadian wildfire smoke has just cleared from the air. I’m sure the bird watchers would attest to the eager chirping as both wildlife and humans greedily enjoy the beautiful weather. But even as the seasons change, so does the technology that drives innovation, as coverage in the July issue of Pharmaceutical Executive® attests.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A Startup Wins the First FDA Approval of a Cell Therapy for Type 1 Diabetes

MedCity News

CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.

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Gaining a Deeper Understanding of Aseptic Needs

PharmaTech

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

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In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

PharmaTech

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

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Quantum Health Teams Up with Progyny for Family Building Benefits Offering

MedCity News

Progyny is now a “preferred partner” on Quantum’s Comprehensive Care Solutions platform, which is a group of benefits solutions that Quantum’s more than 500 employer clients can choose to work with.

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Understanding Nitrosamine Impurities in the Pharmaceutical Industry

PharmaTech

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

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Pharmaceutical Executive, July 2023 Issue (PDF)

PharmExec

Click the title above for a link to open the Pharmaceutical Executive June 2023 issue in an interactive PDF format.

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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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Navigating the Formality Spectrum in ICH Q9(R1)

PharmaTech

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

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The Inspection Result: Warning Letters and Form 483s

PharmaTech

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

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Overcoming Analytical Challenges in High Potency Formulation

PharmaTech

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

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Top 10 Considerations when Meeting with Regulators

PharmaTech

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

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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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Drug Shortages Continue to Plague FDA and Manufacturers

PharmaTech

Problems continue despite actions by regulators to better prevent and address drug shortages.

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Monitoring for Microbes

PharmaTech

Data from environmental monitoring can assist in keeping sterile environments sterile.

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Innovation Idolatry

PharmaTech

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

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New Deal on the Horizon

PharmaTech

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

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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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Improvements to EMA’s PRIME Designation Scheme

PharmaTech

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

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Drug Pricing’s Static Changes

PharmaTech

The debate surrounding drug pricing changes rages on.

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Good Practices for Data Integrity

PharmaTech

Automation can be balanced with operator oversight.

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