Thu.Sep 21, 2023

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Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Fierce Pharma

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.

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The Right Profile & Path

David Bagga

The Medical device sales industry is a well-known career destination that hundreds of thousands of candidates are trying to break into everyday. Medical Device Sales Career Home Blog The Right Profile & Path to take to Breaking into MDS The Right Profile & Path to take to Breaking into Medical Device Sales The Medical device […] The post The Right Profile & Path appeared first on.

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Aurinia quells investor unrest, names founder and ex-CEO Foster to its board

Fierce Pharma

Long categorized as a takeover target, autoimmune disease specialist Aurinia Pharmaceuticals has remained independent, to the frustration of some investors who believe the Canadian company has not | Aurinia has responded to criticism from some investors who believe the company has not maximized its opportunity with lupus nephritis drug Lupkynis. The company named its founder and former CEO Robert Foster to its board of directors in an agreement with major stockholder MKT Capital.

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7 AI Pitfalls That Hospitals Should Avoid

MedCity News

As hospitals across the nation adopt more and more AI technology, there are some common hazards of which they should be wary. During a conference presentation on Tuesday, healthcare AI expert Suchi Saria laid out seven AI pitfalls hospitals should look out for — some of these include being duped by Big Tech companies’ marketing strategies and focusing too much on administrative use cases.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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After FDA rejection, Lilly's ulcerative colitis drug Omvoh picks up support from England's NICE

Fierce Pharma

Even after Eli Lilly missed its first swing at the lucrative U.S. market with ulcerative colitis drug mirikizumab, the company’s launch is gaining steam overseas. | Lilly's mirikizumab is one of several launches the company is counting on for growth in the near term. Even after an FDA rejection, the launch is gaining steam overseas.

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HHS: Medicaid/CHIP Coverage To Be Reinstated for 500K People

MedCity News

Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated.

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More Trending

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Is the ‘Age Wave’ An Opportunity or a Challenge?

MedCity News

Americans are getting older, and some healthcare leaders expect this to be a challenge for the healthcare industry. Others, however, think this is an opportunity for the industry to make improvements, such as engaging adults in their care before they turn 65.

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Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off

Fierce Pharma

Takeda has managed to close one of the antitrust cases that have been hanging over the company. | Takeda has managed to close one of the antitrust cases that have been hanging over the company. The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys.

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Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

PM360

As many in the industry now know, the Inflation Reduction Act (IRA) is the most significant reform of Medicare prescription drug coverage since the creation of Part D and has wide-ranging implications for the healthcare industry. The recent announcement of the first 10 drugs selected for price negotiations is a significant first step in Medicare’s effort to directly set drug prices for seniors.

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Roche scores—again—in hemophilia drug patent case against Takeda

Fierce Pharma

In a patent case centered on two rival hemophilia medicines, Roche's Genentech unit has scored its second straight win. | After Takeda's Baxalta unit moved to appeal a prior loss, the U.S. federal appeals court backed the decision in favor of Roche.

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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 Pharma Brands Grow: An Evidence-based Approach to Pharma Brand Marketing

PM360

Pity the poor pharma brand marketer. Over the past many years, they’ve seen their colleagues on the performance marketing side grow in influence and sophistication as their datasets and digital channels have expanded their value to the business. In contrast, brand marketing can feel like a vestige from another era of marketing, poorly understood, with poor metrics, and little consensus of how brand marketing contributes to the overall business.

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'The Top Line': Fierce Biotech's Fierce 15, plus a deep dive into drug commercialization strategies

Fierce Pharma

In this episode of "The Top Line," Annalee Armstrong and Gabrielle Masson shine a spotlight on some of the most promising companies in the biotech world. | In this episode of "The Top Line," we shine a spotlight on some of the most promising companies in the biotech world and do a deep dive into drug commercialization strategies.

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Merck KGaA Expands in AI-Driven R&D With Two Drug Discovery Deals

MedCity News

Specific targets were not disclosed, but Merck KGaA is betting the artificial intelligence technologies of Exscientia and BenevolentAI will discover into new drugs for cancer, neurology, and immunology.

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Fierce Pharma Asia—Novartis and BeiGene's PD-1 breakup; Genentech's PeptiDream deal; Biocon's new CEO

Fierce Pharma

BeiGene and Novartis have parted ways on the PD-1 drug tislelizumab. Roche's Genentech signed a radiopharmaceutical-peptide conjugate deal with Japan's PeptiDream. | BeiGene and Novartis have parted ways on the PD-1 drug tislelizumab. Roche's Genentech signed a radiopharmaceutical peptide conjugate deal with Japan's PeptiDream. Biocon named a new group CEO.

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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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New manufacturing facility could drive gold standard in cell therapy

European Pharmaceutical Review

A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. To establish it, the Novo Nordisk Foundation is committing up to £127 million. CEO of the Novo Nordisk Foundation Cellerator, Thomas HR Carlsen, told EPR that for cell therapy manufacturing, “The biggest challenge is producing high-quality, consistent cell therapies at the scale required for use in clinical trials… biological complexity [of living cells] means that the man

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Once a Blockbuster Prospect, Is Travere’s Kidney Drug on Track to Become a Bust?

MedCity News

Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.

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3 Steps for More Effective HCP Marketing with Insights from Pfizer

PM360

Some things are better together. While field force activities and digital advertising can be powerful on their own, timely coordination of the two can create an even greater business impact. This “synchronization” helps biopharmas such as Pfizer maximize marketing and field efforts across their organizations to improve engagement with healthcare professionals (HCPs).

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RFID with Barcode Medication Systems: Boosting Hospital Efficiency and Cost Savings

MedCity News

This article explores the benefits of implementing RFID in healthcare settings and how hospitals can gradually transition from barcode to RFID-enabled medication systems, leading to substantial cost savings and improved patient care.

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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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6 Things to Consider to Build Creative that Makes an Impact

PM360

Last we spoke, executing omnichannel digital media using programmatic as the foundation was the topic. But we cannot talk about the media channels and how to connect them without talking about the creative. It has an outsized impact on your media plans’ performance and we need it to drive success. According to Ipsos, 75% of campaign success is driven by the creative.

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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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Key Developments from AMCP 2023 on Blockbuster Generics, Diabetes Drugs, PBM Legislation, and More

PM360

A wave of blockbuster generic drugs launches, new brand drugs that address unmet needs, and legislation that would bring transparency to the pharmacy benefit manager (PBM) industry are just some of the developments that managed care pharmacy leaders are watching closely this year. Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals

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Report urges for new Pharma standards on antimicrobials

European Pharmaceutical Review

A new report published by the Center for Global Development (CGD) has highlighted the need for coordinated global action against antimicrobial resistance (AMR). Experts from organisations such as the Wellcome Trust and Africa Centres for Disease Control and Prevention contributed to the paper, urging governments, industry and international organisations to create a political agreement, or ‘Grand Bargain’, to improve innovation, access, and stewardship for antimicrobials, particularly in low- and

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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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Fostering Better Communication Between COPD Patients and their Doctors—And Why It’s Critical

PM360

Patients living with chronic obstructive pulmonary disease (COPD) need help having earlier, more honest, and more effective conversations with their doctors about their illness. That’s one key takeaway from a recent survey of more than 1,000 patients, the findings of which suggest that inadequate patient-provider communication may be a contributing factor to poorer quality of life for COPD patients.

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Streamlining the Referral Process with AI

Referral MD

Artificial Intelligence (AI) has enormous potential to revolutionize the medical industry, leading to better patient outcomes, more efficient diagnoses, and improved workflows. One area where AI can make an impactful difference is streamlining the referral process for doctors and patients, reducing wait times, and improving the overall quality of healthcare.

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Lessons Learned from CMS’ Alzheimer’s Drug Coverage Decision

PM360

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. The scientific breakthroughs that led to these new therapies came after decades of research in AD and studies of more than 200 drug candidates.

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Harnessing the Power of Phone Interactions in Healthcare [Sponsored]

MedCity News

A human touch makes a significant difference in healthcare call interactions where an automation-dominant approach would fall short.

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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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Digital Biomarkers: The Next Frontier in Clinical Trial Advancement

PM360

As the drug landscape grows increasingly competitive, it will be vital to gain an intimate, personalized understanding of how individual patients respond to medication to highlight a drug’s value on their quality of life. Digital biomarkers powered by artificial intelligence (AI) are already providing critical insights to personalize care and draw more comprehensive conclusions about a therapy’s impact.

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FUJIFILM Diosynth Biotechnologies Completes New Viral Vector Gene Therapy Manufacturing Facility in UK

PharmaTech

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

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Parkinson’s UK calls on government to mark World Patient Safety Day

PharmaTimes

The report outlines ways the government can help patients with Parkinson’s disease - News - PharmaTimes

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Kezar and Everest enter lupus nephritis therapy development deal

Pharmaceutical Technology

Kezar and Everest Medicines have signed a deal for the development and commercialisation of zetomipzomib for lupus nephritis.

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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.