Thu.Oct 12, 2023

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After Novo's Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

Fierce Pharma

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. | Based on the inclusion criteria for Novo Nordisk’s chronic kidney disease trial, dialysis bigwig DaVita believes there may only be “limited application” of the study’s findings to the overall CKD population.

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Customer experience in Europe: a digital drop-off for the pharma content HCPs most need

Dominic Tyer

There’s a digital drop-off for the pharma content that HCPs in Europe’s five biggest markets say they need the most from the industry.

Pharma 130
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After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

Fierce Pharma

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA during a reinspection of the company's factory in Iceland earlier this year.

FDA 262
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EU Orders Grail Sale; Illumina Continues Appeals But Plans for Multiple Outcomes

MedCity News

European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.

Sales 109
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer

Fierce Pharma

Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence. | Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence.

Pharma 221
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4 Ways Investors Think the Health Tech World Will Change in 2024

MedCity News

At HLTH, Bessemer investors Sofia Guerra and Steve Kraus detailed four predictions about where they think the digital health world is headed in 2024. One of these was that “services-as-software” will emerge as a new category of healthcare AI. Another was that some healthcare technology vendors will have to rethink their distribution models and rely on indirect monetization strategies.

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Noom Offers Clinical Obesity Management Platform to Employers

MedCity News

Noom is now offering Noom Med to employers. The program is intended for patients who need more clinical support in their weight loss journey. It offers access to a clinician and medications, including GLP-1s.

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Fierce Pharma Asia—GSK, Zhifei's vaccine pact; BioNTech's latest China deal; Biocon's biosimilar rejection

Fierce Pharma

GSK has tapped Chongqing Zhifei to distribute Shingrix in China. BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. | GSK has tapped Chongqing Zhifei to distribute Shingrix in China. BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. The FDA rejected Biocon's proposed biosimilar version of Novo Nordisk's NovoLog—again.

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Walmart: Included Health Has Proved Its Value to Our Virtual Primary Care Program

MedCity News

Walmart’s relationship with Included Health dates back to 2016 when its previous incarnation – Doctor on Demand – began providing virtual urgent care services to Walmart employees in three states. Nearly eight years later, the San Francisco company continues to be the only partner charged with delivering virtual primary care to almost 1 million people in 49 states.

Doctors 107
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Precision marketing: leveraging data and innovative content creation

Fierce Pharma

In this discussion, Steve Carickhoff, President of BioPharm Communications, a company specializing in third-party, omnichannel promotion, discusses some of the challenges and opportunities facing p | As pharma evolves it’s marketing approach should be more omnichannel focused, there is more to the equation than just how to use data. Depth of content is an equally important variable in the mix.

Marketing 130
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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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BioNTech Turns to China Again for Cancer Drugs, Paying $70M to Partner on an ADC

MedCity News

BioNTech gains rights to a MediLink Therapeutics antibody drug conjugate that targets tumors expressing the HER3 protein. The deal comes six months after the German company entered the ADC field by acquiring rights to two therapeutic candidates from DualityBio.

Biopharma 105
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New FDA SaMD Guidance Will Bring Monumental Changes to Industry

PharmExec

A discussion of the impact the new FDA SaMD guidance, identifying the differences between companion apps and SaMD, and what to expect from this combination in the future.

FDA 105
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MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials

European Pharmaceutical Review

A new scheme from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to cut the approval time for the lowest-risk clinical trials in the UK by over half. The new Notification Scheme is based on that outlined in the MHRA’s clinical trials consultation, which was endorsed by 74 percent of those who responded. It forms a significant part of the regulator’s overhaul of the clinical trials regulation announced in March 2023, which aims to make the UK a prime location for con

Ethics 94
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AstronauTx completes £48m series A financing for Alzheimer’s disease

PharmaTimes

The financing will support the biotech’s clinical study of people with AD as a lead programme - News - PharmaTimes

Leads 111
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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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eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities

PharmaTech

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

Pharma 98
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MedCity FemFwd Podcast: SCAN Inspired With Nancy Monk, Chief Operations Officer of SCAN Health Plan

MedCity News

In this episode, we discuss SCAN Health Plan’s recent launch of SCAN Inspired, a Medicare Advantage plan designed for women.

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Research predicts 2029 small molecule oncology market leaders

European Pharmaceutical Review

Strong demand for small molecules as treatment for non-small cell lung cancer (NSCLC) in the eight major markets means that the small molecule treatment market for the disease is expected to reach over $15 billion by 2029. This represents approximately 40 percent of the total NSCLC market, stated GlobalData. Sales for AstraZeneca’s Tagrisso are anticipated to exceed $7 billion and hold a 48 percent share of the market of small molecules in lung cancer treatment by 2029, according to data and ana

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IMIDomics partners with UB to advance IMIDs treatments

Pharmaceutical Technology

IMIDomics has entered into a licence and partnership agreement with the University of Barcelona (UB) to advance treatments for IMIDs.

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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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GSK and Zhifei Partner to Extend the Availability of Shingrix

PharmaTech

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

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Securing the Safety Net in Drug Access and Support

PharmExec

A look at the intersection of rigorous compliance and ethical behavior: independent, charitable patient assistance foundations.

Safety 98
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University of Edinburgh to lead new Exascale supercomputer

PharmaTimes

The service will benefit major research and industry projects across the UK - News - PharmaTimes

Leads 104
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Value-Based Care: How Payers Can Empower Providers to Deliver Better Outcomes

Clarify Health

The concept of value-based care (VBC) isn’t new — but the industry’s journey to achieve it is far from over. After two decades, healthcare is still working to find a better way to reward clinicians for the quality and efficiency of the care they provide rather than for the volume of patients treated. Payers are uniquely positioned to drive value-based care Healthcare payers can play a significant role in helping providers deliver better patient outcomes as they have a unique combin

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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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The Creative Floor Awards Create Health & Smellness Candle Art Collection

PM360

The Creative Floor Awards have created a brand new working from home candle collection that will be an additional revenue generator for their Talent & Diversity Fund. The platform has collaborated with the world’s best mixologists and yogis to create four exclusive scents to help people thrive with working from home. Only 100 candles per scent have been created.

Ethics 59
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Redefining Artificial Intelligence [New Report]

Clarivate

In a world driven by rapid advancements in artificial intelligence (AI), the landscape of intellectual property (IP) law and practice is poised for a transformative shift. Generative AI has entered the mainstream with a ripple effect on the industry. Our latest report, Redefining AI: How IP Practice Meets the Coming Wave, puts the perception of AI front and center to understand what’s next for the IP.

Ethics 59
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Incyte’s oral vitiligo drug heading for phase 3

pharmaphorum

Incyte’s oral vitiligo drug heading for phase 3 Phil.

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Validated processes in granulation - How to produce the perfect particle

PharmaTech

Do you face challenges when it comes to the particle quality in your granulation process? In order to produce granules with the desired properties, scale-up is crucial, in addition to looking at the process parameters. After all, the path of a drug from the laboratory to production holds many a surprise. Especially in the case of particles for inhalers, the mixing process plays a decisive role.

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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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The Power of Care Coordination: Improving Patient Engagement

Referral MD

Photo by Luis Melendez on Unsplash Improving patient engagement has recently become a top priority in the healthcare sector. This shift has been driven by the realization that involving patients in their care can lead to better health outcomes and increased satisfaction. One major factor that promotes patient engagement is care coordination. This blog post will discuss how care coordination enhances patient engagement and its impact on healthcare.

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The Challenges of the Journey from Clinical to Commercial Cell Therapies

PharmaTech

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements.

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OptimizeRx Announces Agreement to Acquire Medicx Health for $95 Million to Expand its Omnichannel Reach to Consumers

PM360

OptimizeRx Corp., the leading provider of healthcare technology solutions helping life sciences companies reach and engage healthcare professionals (HCPs) and patients, today announced it has signed an agreement to acquire Scottsdale, Arizona-based Healthy Offers, Inc., dba Medicx Health , a leading healthcare consumer-focused omnichannel marketing and analytics company.

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CCC Updates Its Open Access Modeling and Analytics Tool

Copyright Clearance Center

CCC added new data import capabilities and AI-enabled affiliation matching in its OA Agreement Intelligence modeling and analytics tool that provides publishers with a 360-degree view of disambiguated publication data to build accurate, transparent institutional offers regarding OA.

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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.