Fierce Pharma

NOVEMBER 27, 2023

After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. | After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. Now, some three weeks later, he’s putting his company’s money where his mouth is.

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Manufacturing 280

MedCity News

NOVEMBER 27, 2023

Novo Nordisk’s planned expansion will more than double the footprint of its France production site, bringing new capacity for manfacturing GLP-1 drugs for metabolic conditions. The location is already one of the company’s largest for making diabetes products.

Biopharma 118

Biopharma Pharma 118

Fierce Pharma

NOVEMBER 27, 2023

Eli Lilly’s fortunes have turned quickly. | It was the second straight quarter where the overwhelming success of blood sugar regulating treatments were the dominant story in the biopharma industry. Eli Lilly and Novo Nordisk delivered the highest revenue gains, at 38% and 29%, respectively.

Biopharma 268

Biopharma Pharma 268

Healthcare Success

NOVEMBER 27, 2023

Doctors are central to the success of virtually every multi-location healthcare practice and health system we work with. Moreover, today’s doctor partners have strong opinions about marketing and growing their locations within the larger business. Some of the hospitals and multilocation practices that engage our agency have doctors, executives, investors, and other stakeholders aligned around their brand strategy and marketing plan.

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Doctors Marketing Healthcare Healthcare 117

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Distribution

Fierce Pharma

NOVEMBER 27, 2023

Following the historic approval of the world’s first CRISPR-based gene-editing therapy in the United Kingdom this month, Vertex Pharmaceuticals has tapped its long-time manufacturing partner Roslin | RoslinCT, the CDMO arm of the Roslin Institute, is set to manufacture Vertex and CRISPR Therapeutics’ exa-cel “across the world” as part of Vertex’s global production network.

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Manufacturing Networking Pharmaceutical 259

PM360

NOVEMBER 27, 2023

Quality in software is a multifaceted concept, closely tied to both conformance to requirements and fit for purpose. In the life sciences industry, where software permeates everything from the drug discovery process to pharmaceutical supply chain management, the need for rigorous fit-for-purpose evaluations has never been more critical. As pharmaceutical regulations increasingly intersect with software development standards, the traditional approach to Computer System Verification (CSV) is falli

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Engineering Medical science Healthcare Provider Healthcare 115

MedCity News

NOVEMBER 27, 2023

One investor is most interested in mental health startups that focus on high acuity care, while another wants to see companies that are built with the end-user in mind, they shared during recent interviews.

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Fierce Pharma

NOVEMBER 27, 2023

Sanofi and Regeneron’s Dupixent has scored in a second phase 3 study in chronic obstructive pulmonary disease (COPD), setting up the monoclonal antibody to become the first biologic to treat the lu | Sanofi and Regeneron’s Dupixent has scored in a second phase 3 study in chronic obstructive pulmonary disease (COPD), setting up the monoclonal antibody to become the first biologic to treat the lung disease and the first advancement in the indication in more than a decade.

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PM360

NOVEMBER 27, 2023

No one wants to deal with a hormonal mouse. When I was a graduate research assistant, I studied the impact of enriching a human’s environment on cognition. My research was conducted on mice, but not every type of mouse. In fact, a large portion of the mouse population was purposefully left out of the study. The reason was simple: female hormones could potentially affect our data.

Healthcare 111

Healthcare Healthcare Medicine FDA 111

Fierce Pharma

NOVEMBER 27, 2023

Sponsors, CROs, sites, and anyone else involved in running clinical trials must consider the risk of suicidality. But deep-rooted misconceptions get in the way. | The suicide rate is rising so it’s more important than ever for site staff and principal investigators to assess suicide risk across all trials.

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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.

Safety

PM360

NOVEMBER 27, 2023

This is the second article in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the U.S. and Europe. In this article, we investigate strategies that manufacturers could consider to optimize pricing and access opportunities for their combinations in today’s environment. (You can find part one here.

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Manufacturing Marketing Competition Patients 111

Fierce Pharma

NOVEMBER 27, 2023

THIS IS WHERE THE TEXT OF THE ARTICLE WILL BE. | The introduction that will be displayed in the newsletter.

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Training 147

MedCity News

NOVEMBER 27, 2023

At RSNA 2023, healthcare AI startup Paige announced a partnership with Nuance to launch what the companies say is “the largest digital consultation network in pathology.” Paige’s digital pathology tools will be embedded into PowerShare, Nuance’s nationwide image sharing network with the goal of connecting more pathology labs to expert second opinions.

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Networking Consulting Healthcare Healthcare 106

PM360

NOVEMBER 27, 2023

Up to now, drug safety teams have relied primarily on reactive reporting systems for pharmacovigilance (PV) or real-world drug safety monitoring. The signals, generally delivered through individual case safety reports (ICSRs), require significant time and effort to uncover, potentially delaying detection and negatively impacting patient safety. Most traditional signal detection methods focus on disproportionality, meanwhile calling attention to higher-than-expected correlations between the suspe

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Safety Electronics Patients Physicians 106

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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

Distribution

MedCity News

NOVEMBER 27, 2023

GSK took Blenrep off the market last year after the multiple myeloma drug failed its confirmatory study. But GSK now says it has interim data showing Blenrep beat a blockbuster Johnson & Johnson drug in a head-to-head Phase 3 study testing it as an earlier line of therapy.

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Marketing Biopharma Pharma 103

PM360

NOVEMBER 27, 2023

I recently sat down with Erica Taylor, PhD, Vice President and Chief Marketing Officer at Genentech, to talk about the future of biopharma marketing and creating more meaningful content. In Erica’s role, she sets the vision, strategic enterprise leadership, and direction for the marketing function at Genentech, covering the company’s full commercial portfolio.

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Marketing Customer Relationship Management Relationship management Education 105

MedCity News

NOVEMBER 27, 2023

Seniors are mostly still interested in $0 premium Medicare Advantage plans, according to a new eHealth report. However, slightly fewer seniors are choosing these plans compared to previous years.

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PM360

NOVEMBER 27, 2023

Continuing medical education (CME) is a top priority for healthcare providers in order to maintain their medical licensure, broaden and update their clinical knowledge, hone their skills, feed their curiosity, and ensure patients receive the best care and outcomes. Education companies that develop content have a list of considerations to meet when creating learning materials.

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Education Medical Training Healthcare 105

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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.

Safety

European Pharmaceutical Review

NOVEMBER 27, 2023

The National Institute for Health and Care Excellence (NICE) has recommended enzyme replacement therapy sebelipase alfa (Kanuma ® ▼) in final draft guidance. Alexion’s (AstraZeneca Rare Disease) intravenous treatment is recommended for children who have been diagnosed with Wolman Disease at two years old or younger. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

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Food and Drug Administration Consulting Food Medicine 96

PM360

NOVEMBER 27, 2023

I started my Insights career at a medical devices division of one of the world’s largest pharmaceutical companies. A significant shake-up at the company marked the start of my tenure: a newly appointed CEO with a consumer-packaged goods (CPG) background introduced a new Chief Marketing Officer (also from CPG) and an influx of global marketers from renowned companies such as P&G, Kraft, and Coca-Cola.

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Marketing Recruitment Patients Manufacturing 104

pharmaphorum

NOVEMBER 27, 2023

EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.

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Medical Pharma 93

MedCity News

NOVEMBER 27, 2023

As we navigate the complex terrain of virtual care integration, it is imperative to recognize the significance of payers as catalysts for change.

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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.

Specialization

PharmaVoice

NOVEMBER 27, 2023

A drug developed by Kinnov Therapeutics halved alcohol consumption in heavy drinkers in a mid-stage study

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Pharmaceutical Technology

NOVEMBER 27, 2023

Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.

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FDA 98

PharmaTimes

NOVEMBER 27, 2023

The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes

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Medicine Patients 108

pharmaphorum

NOVEMBER 27, 2023

A year after GSK pulled its BCMA-targeting antibody-drug conjugate (ADC) Blenrep from the US market as a later-line therapy for multiple myeloma, there are signs that the drug may still have a role to play earlier on in the treatment pathway.

Marketing 70

Marketing 70

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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

Leads

Clarivate

NOVEMBER 27, 2023

A new global survey captures community challenges and views on the future of research A new report from Research Professional TM News, an editorially independent part of Clarivate TM , explores the key priorities, challenges and drivers of change for academic research offices. Based on a global survey of more than 1,600 research office staff and researchers, Research Offices of the Future provides a comprehensive snapshot of the current state of research offices and their relationship with resea

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Training Government Management 69

PharmaTimes

NOVEMBER 27, 2023

Around £330m will be invested in the software over the next seven years - News - PharmaTimes

Patients 89

Patients 89

European Pharmaceutical Review

NOVEMBER 27, 2023

The National Institute for Health and Care Excellence (NICE) has recommended enzyme replacement therapy sebelipase alfa (Kanuma ® ▼) in final draft guidance. Alexion’s (AstraZeneca Rare Disease) intravenous treatment is recommended for children who have been diagnosed with Wolman Disease at two years old or younger. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

Food and Drug Administration 59

Food and Drug Administration Consulting Food Medicine 59

pharmaphorum

NOVEMBER 27, 2023

Dupixent aces second COPD study, setting up FDA filing Phil.

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FDA 93

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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.

Management