Thu.Jun 08, 2023

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Sanofi, AstraZeneca's RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Fierce Pharma

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle. | Seeking to launch their RSV prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.

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Why One Healthcare Lawyer Thinks Merck’s Drug Pricing Lawsuit Defense ‘Makes No Sense’

MedCity News

Merck recently became the first drugmaker to sue the federal government over its Medicare drug price negotiation program. The company’s lawsuit argues that the program violates the Constitution’s First and Fifth Amendments, but healthcare law expert Robin Feldman said the defense doesn’t have any legs.

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Sandoz hitches its wagon to biosimilars, predicting $3B in sales from pipeline products over next 5 years

Fierce Pharma

Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline | Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline in revenue every year since 2016. But the slide could end soon as the company projects sales of its pipeline products to add $3 billion to the top line over the next five years, thanks largely to biosimilars.

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What The Medical Community Needs to Know to Improve Care for Neurodivergent Patients

MedCity News

Walking into a doctor’s office and facing the bright, fluorescent lights. Sitting on the rough, crinkly paper on the exam table. Repeatedly filling out the same dense intake forms about your health history. Situations like these can be an annoyance for neurotypical patients. For neurodivergent patients, they’re obstacles to getting adequate care. One in five adults in the US is neurodivergent, including those experiencing conditions like autism, attention-deficit/hyperactivity disorder (ADHD), o

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Activist shareholders blast Merck's IRA lawsuit, urge company to reconsider

Fierce Pharma

After Merck filed a bombshell lawsuit contesting the negotiation measures in the Inflation Reduction Act (IRA), the company’s shareholders at the Interfaith Center on Corporate Responsibility (ICCR | After Merck's bombshell lawsuit contesting the Inflation Reduction Act, shareholders at the Interfaith Center on Corporate Responsibility are asking the company to reconsider.

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Deal of the week: Strive Health raises $166m to aid kidney health services

Pharmaceutical Technology

Each week, Pharmaceutical Technology’s editors select a deal that illustrates the themes driving change in our sector. The deal may not always be the largest in value, or the highest profile. But it will tell us where the leading companies are focusing their efforts, and why. This new, thematic deal coverage is driven by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors.

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iLet Bionic Pancreas Cleared by FDA

Medgadget

The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. The device is offered by Beta Bionics , a medtech company based in Massachusetts and California, but the underlying technology originally developed by researchers at Boston University. The system can be paired with a Bluetooth glucose monitor to deliver personalized insulin dosing every five minutes, and calculates doses based on past and current glucose levels and its expe

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'The Top Line': News from ASCO's annual meeting, plus this week's headlines

Fierce Pharma

In this episode of the "The Top Line," we talk with Fierce’s Gabrielle Masson and Andrea Park about the most important news coming from this year's annual ASCO meeting. | This week on "The Top Line," we discuss the the top news from this year's annual ASCO meeting, plus contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines.

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Accelerating the Move to Precision Oncology

MedCity News

By continuing an open discussion on precision medicine and precision care, we can truly accelerate pharmacogenomic testing to its full potential and focus on providing the highest quality care to those who need it most.

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After nationwide deal, Teva reaches $193M opioid settlement with holdout Nevada

Fierce Pharma

When Teva proposed its sweeping $4.25 billion opioid settlement to resolve thousands of claims across the country, all U.S. states except for Nevada and New Mexico jumped on board. | Nevada was one of two holdouts in Teva's sweeping $4.25 billion opioid settlement that won the support of 48 states. Now, the sides have reached a separate agreement.

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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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How to Write an About Us Page for a Healthcare Business (With Examples)

Healthcare Success

What do you consider the most important pages on your healthcare website? After the homepage, many might say it’s their products or services pages. However, the About Us page is among the most important and highly trafficked web pages. In many cases, it's also a critical part of the consumer's buying journey. Fifty-two percent of study respondents said the first thing they want to see when they land on a website is a company’s About Us page, according to a B2B Web Usability Report. 1 Most people

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FDA grants orphan drug designation to DTx Pharma’s CMT1A therapeutic

Pharmaceutical Technology

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. It induces remyelination of axons to normal levels, increases muscle coordination, agility, mass, grip and strength, and improves electrophysiological measurem

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2023 Pharm Exec Top 50 Companies

PharmExec

With the sales boom from COVID-19 products now in the rear-view, a resetting is underway for those in Pharm Exec’s listing of the top biopharma producers—shifting attention to new Rx roads ahead and the steady strategies needed to navigate a bumpy business terrain.

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How Medicare Coverage Diversifies Access to Innovation

MedCity News

Appropriate Medicare reimbursement of high-intensity focused ultrasound for prostate disease is a significant development for the treatment for men 65 years and older today.

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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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4DMT’s CF gene therapy posts early cues for improving patient outcomes

Pharmaceutical Technology

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS). While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the dr

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Report: Medicare Spending Reached $744B in 2022

MedCity News

A new KFF analysis showed that Medicare spending per person increased to $15,700 in 2022 from $5,800 in 2000, representing a 4.6% average annual growth.

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Purchasing a Scientific Article? 4 Things to Keep in Mind

Copyright Clearance Center

Whether you’re a researcher working on a one-off project, or you’re looking to purchase scientific articles for your organization, here are a few considerations for purchasing STM articles from a document delivery provider.

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Vertos Medical Raises $26M for Minimally Invasive Spinal Procedure

MedCity News

Medical device maker Vertos Medical recently snagged $26 million in a Series C funding round. The company’s flagship product is a minimally invasive procedure that removes small pieces of bone and ligament that cause lumbar spinal stenosis.

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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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Shifting to Commercialization

Pharmaceutical Commerce

Sy Pretorius, COO & president of outsourced solutions at Eversana, dives into his new role in the space, after being a veteran in the clinical development sector.

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Prescription For Success: Invest in the Pharmacy Now to Realize Financial Growth

MedCity News

Hospital executives should rethink the immediate impulse to achieve savings by cutting pharmacy jobs and instead focus on fixing this integral part of a hospital system’s functionality.

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Acoustic-Powered Microrobots for Bladder Disease Treatment

Medgadget

Engineers at the University of Colorado at Boulder have developed a medical microrobot that is powered by acoustic waves. The tiny devices, which are 20 micrometers wide and considerably smaller than the width of a human hair, can move incredibly fast for their size, achieving a speed of 3 millimeters per second. To put this in context, if a microrobot and a cheetah the same size had a race, the microrobot would win comfortably.

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Sanofi, AstraZeneca RSV Drug for Infants Secures Backing of FDA Advisors

MedCity News

An FDA advisory committee voted in favor of supporting a respiratory syncytial virus therapy designed to protect newborns and infants. The antibody drug developed by partners Sanofi and AstraZeneca is currently under regulatory review.

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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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Yes, biopharma still has a reputation problem. These leaders are looking for solutions

PharmaVoice

Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.

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Transcarent, ViewFi Partner To Bring Orthopedic Consult Solution to Patients

MedCity News

ViewFi will power Transcarent’s orthopedic consult solution, which will be part of Transcarent’s surgery care services. Through Transcarent’s app, patients will be able to have a virtual diagnostic consultation with an orthopedic provider in less than two days.

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Biopharma struggling to find talent with adequate digital skills

European Pharmaceutical Review

A new report by the Association of the British Pharmaceutical Industry (ABPI) has identified the UK biopharma industry is increasingly seeking talent with artificial intelligence (AI) and data skills to maintain competitiveness as digital technology continues to drive innovation. The research highlighted trends and gaps in skills within the UK pharmaceutical industry, based on survey data from over 30 different employers.

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Innovative CGT Catapult labs open doors

PharmaTimes

Laboratory space will accelerate the development of potentially life-saving cell therapies - 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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Device Moves Esophagus for Cardiac Ablation Procedure

Medgadget

Researchers at the Ohio State University Wexner Medical Center have developed a medical device that is intended to improve patient safety during cardiac ablation procedures to treat atrial fibrillation (AFib). At present, the esophagus can lie very near to the target tissue during cardiac ablation, leading to esophageal injury in many patients. This device is advanced down the esophagus and applies gentle suction to the esophageal wall to move the esophagus gently to one side, away from the abla

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Linear Diagnostics develops 20-minute STI test

PharmaTimes

Emergence of quick test follows recent dramatic increase in sexually transmitted infections - News - PharmaTimes

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Merck Files Lawsuit Against Federal Government

Pharmaceutical Commerce

Pharma company claims that the IRA’s drug pricing clauses violate the First and Fifth Amendments.

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Novel nanofiltration method for microbial biosurfactant downstream processing

European Pharmaceutical Review

A study has reported for the first time, an innovative downstream method for mannosylerythritol lipids (MELs), were separated from the crude MEL mixture in a first stage with the other lipid derivatives (free fatty acids, mono- and diacylglycerols) removed by organic solvent nanofiltration (OSN). Based on the OSN, the novel approach for the purification of glycolipid microbial biosurfactant, uses only one solvent and reaches a 98 percent purity.

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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.