Mon.Dec 11, 2023

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As ICER places a spotlight on pharma's price hikes, J&J, Roche and more hit back

Fierce Pharma

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end u | The Institute for Clinical and Economic Review (ICER)’s fifth annual report on unsupported price increases (UPI) puts Humira in the top spot of offenders.

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Fruit Street Health Sues Sharecare for $25M

MedCity News

Fruit Street Health’s complaint alleged that Sharecare violated the terms of their shared business agreement by rolling out its own version of Fruit Street’s diabetes prevention program, which had been previously offered to Sharecare members. Sharecare said that the lawsuit is baseless.

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ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Fierce Pharma

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy aliu Mon, 12/11/2023 - 14:51

FDA 248
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ASH 2023: microbiome-based therapy shows potential in graft-versus-host disease

European Pharmaceutical Review

Results from MaaT Pharma’s Early Access Program (EAP) for its microbiome-based therapy MaaT013, have demonstrated positive overall response and overall survival rates in European patients with graft-versus-host disease (GvHD). The findings were presented at the 2023 American Society of Hematology (ASH) Annual Meeting. MaaT013 is an off-the-shelf, pooled-donor, enema Microbiome Ecosystem Therapy TM.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sanofi taps local drugmaker Minapharm to crank out popular blood thinner Clexane in Egypt

Fierce Pharma

Sanofi has been in the Egyptian manufacturing game for decades, but that doesn’t mean the French pharma can’t use a helping hand from time to time. | Under a new exclusive deal with Sanofi, local drugmaker Minapharm has been put in control over manufacturing and supply of the popular anticoagulant Clexane in Egypt.

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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

PharmExec

Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

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'The Top Line': A closer look at the Fierce 50

Fierce Pharma

Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. | The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees

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4 Senators Urge CMS To Collect, Publish More Data on MA Plans

MedCity News

In a letter to CMS, four senators asked for better data collection on the practices of Medicare Advantage plans, including when it comes to prior authorization.

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The Boston Globe Names CCC a 2023 Top Place to Work in Massachusetts for Third Year in a Row

Copyright Clearance Center

December 11, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, has been named one of the Top Places to Work in Massachusetts in the large employer category for the third year in a row in the 15 th annual employee-based survey project from The Boston Globe.

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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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Privia Medical Group Teams Up with Iron Health To Advance OB/GYN Care

MedCity News

Privia Medical Group Gulf Coast has launched Privia Wellness, which offers weight management, hormone replacement therapy, sleep and brain health and nutraceuticals. The weight management support is provided by Iron Health, a virtual care platform.

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What Is Cold Calling (and How to Address Your Sales Team’s Aversion To It)?

Integrity Solutions

What is cold calling and what does it look like in the current sales world? Your mindset may actually be the key to success. If you want to hear salespeople groan, mention cold calling. It’s true that cold calling can be hard, grinding-it-out work, and the rewards aren’t instant. But sales prospecting is the bread-and-butter, core activity that leads to sales growth and success — and cold calling is one of the most effective prospecting strategies available.

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Crossing the Interoperability Finish Line: Will TEFCA Help?

MedCity News

TEFCA’s goal is to establish a universal floor for interoperability across the country by developing the infrastructure model and governing approach for users in different networks to securely share basic clinical information with each other.

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GSK immuno-oncology treatment achieves novel EU approval

European Pharmaceutical Review

The European Commission (EC) has approved the first frontline immuno-oncology treatment in the EU for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) plus carboplatin-paclitaxel chemotherapy is indicated for these patients who are suitable for systemic therapy.

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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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Connecting the Clinical Ecosystem to Alleviate Site Burden

MedCity News

The future of clinical research is a connected user experience with automated workflows, streamlined document exchange and transparency to accelerate studies without compromising compliance.

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Plant-Based Soft Medical Robots

Medgadget

Researchers at the University of Waterloo in Canada have developed plant-based microrobots that are intended to pave the way for medical robots that can enter the body and perform tasks, such as obtaining a biopsy or performing a surgical procedure. The robots consist of a hydrogel material that is biocompatible and the composite contains cellulose nanoparticles derived from plants.

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With More 2024 FDA Filings Planned, Novartis Drug Starts Showing Blockbuster Potential

MedCity News

Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations.

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UKHSA urges individuals from ethnic minority groups to get vaccinated

PharmaTimes

New data highlights the inequalities in emergency hospital rates and vaccinations - News - PharmaTimes

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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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First gene therapies for sickle cell disease secure FDA approval

Pharmaceutical Technology

The FDA has approved Vertex/CRISPR’s Casgevy and bluebird bio’s Lyfgenia gene therapies for the red blood cell disorder.

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NHS rolls out online GP registration to over 2,000 practices

PharmaTimes

Around 2,100 GP surgeries had enrolled into the digital service by the end of November - News - PharmaTimes

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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

Patients 105
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In Praise of the Title Verso

Copyright Clearance Center

Critically for Richard Charkin, the title verso is where to find who is the copyright holder.

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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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Trade & Channel Strategies 2023: An Interview with Paul Chen of Lexicon Pharmaceuticals

Pharmaceutical Commerce

Lexicon Pharmaceuticals exec discusses upcoming Enable Holistic Hub and Provider Services panel.

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FDA Expands Indication of Cresemba for Use in Children With Invasive Aspergillosis, Invasive Mucormycosis

PharmExec

Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.

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Trade & Channel Strategies 2023: A Dive into Pharmacy and the Distribution Channel

Pharmaceutical Commerce

Conference keynote offers an industry outlook, including new commercialization challenges.

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Is Trust the Secret Ingredient for Digital Product Success?

PharmExec

Lack of trust in pharma-provided content proves to be a key barrier to successful engagement, highlighting issues like promotional spin, information availability, and more.

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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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MSD, Moderna take mRNA jab into phase 3 for lung cancer

pharmaphorum

MSD, Moderna take mRNA jab into phase 3 for lung cancer Phil.

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Unleash the Power of Productivity with SPOTIO’s “Download My Day” Feature

Spotio

In the dynamic world of field sales, staying connected is crucial. But what happens when you find yourself in a signal dead zone? Enter “Download My Day,” SPOTIO’s game-changing feature designed to keep you in control, even when connectivity is a challenge. Let’s explore how this innovative addition to the SPOTIO app can transform your field experience.

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Key Strategies to Boost Furniture Sales Among Budget-Conscious Consumers

Contrarian Sales Techniques

As someone who's interested in the furniture market, I've been pondering how you can elevate your store's appeal to budget-conscious consumers. This segment, while price-sensitive, presents a substantial opportunity for growth and loyalty. I'd like to share some targeted strategies that could help you tap into this market more effectively. Of course, you can always take a quick look at my 8 suggestions for increasing furniture sales.

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Is Trust the Secret Ingredient for Digital Product Success?

Pharmaceutical Commerce

To rebuild trust, companies should utilize a customer-centric approach, focusing on transparent and neutral content incorporating medical expertise and regularly seeking HCP feedback.

Medical 52
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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.