Tue.Mar 05, 2024

article thumbnail

Novo Nordisk's success with Ozempic in diabetes and kidney disease patients isn't enough for investors

Fierce Pharma

A trial of Novo Nordisk's Ozempic on diabetes and kidney disease patients found that it reduced the risk of disease progression and death by 24%.

Patients 281
article thumbnail

Reducing Burnout Requires Giving Health Care Workers More Control Over Their Time

MedCity News

One way that we can address this root cause of burnout is by supporting health care workers in using their time most effectively. That involves deploying technologies that make their lives easier.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Vanda's jet-lag approval hopes for Hetlioz quashed with FDA hearing rejection

Fierce Pharma

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. | Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.

FDA 248
article thumbnail

New Novo Nordisk Ozempic Data Build Case for Adding Kidney Disease to Label

MedCity News

Blockbuster Novo Nordisk drug Ozempic now has clinical trial results showing statistically significant reductions in the risk of kidney disease progression. The company said these results support the expansion of the drug’s label to chronic kidney disease.

Biopharma 115
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Bayer CEO launches ‘full-scale effort’ to rejuvenate pharma pipeline, tables split-up but warns not never

Fierce Pharma

Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as man | Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as many investors had hoped for.

Pharma 232
article thumbnail

FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

MedCity News

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies.

FDA 110

More Trending

article thumbnail

FarmboxRx Unveils Maternal Health Program

MedCity News

FarmboxRx’s new maternal health program sends members a food box, along with educational content to support them during their pregnancy. This content focuses on a variety of topics, including prenatal and postpartum care visit compliance, postpartum mental health, immunizations and prenatal and postpartum nutrition.

Food 107
article thumbnail

GSK rewards CEO Walmsley with 51% pay hike after beating sales, profit goals

Fierce Pharma

With the fortunes of GSK on the rise after much tumult early in the decade, the company has rewarded CEO Emma Walmsley with a significant pay boost. | With the fortunes of GSK on the rise after much tumult early in the decade, the company has rewarded CEO Emma Walmsley with a significant pay boost. Walmsley collected 12.7 million pounds ($16 million) in total pay last year, a 51% increase from her compensation in 2022.

Sales 201
article thumbnail

Surprise Enhertu rejection follows NICE process change

pharmaphorum

NICE has rejected the use of AstraZeneca and Daiichi Sankyo’s Enhertu as an NHS treatment for advanced HER2-low breast cancer, a decision that the companies have described as “devastating”.

106
106
article thumbnail

Sumitomo Pharma, suffering from sliding sales, lays off another 400 US staffers

Fierce Pharma

Sumitomo Pharma’s hundeds of layoffs last summer weren't enough for the struggling company to stem the tide as its revenues decline and its

Sales 210
article thumbnail

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.

article thumbnail

NICE backs frontline use of Jemperli in endometrial cancer

pharmaphorum

GSK’s PD-1 inhibitor Jemperli has been cleared for use by the NHS as a first-line treatment for a specific type of endometrial cancer, making it an option for around 580 women across England, Wales and Northern Ireland.

101
101
article thumbnail

After Formosa snags FDA nod for reformulation of old steroid, partner Eyenovia plots launch

Fierce Pharma

Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid. | Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid. With that, the company's U.S. commercialization partner, Eyenovia, is gearing up for a launch.

FDA 164
article thumbnail

What Do We Do with All of This Data?

MedCity News

Today, clinicians have to spend an inordinate and impractical amount of time combing through the EHR just to find the information they need to provide that level of care. All of that back-end administrative work should be the function of technology.

article thumbnail

CCC to Host Publisher Panel on Copyright and AI at 2024 London Book Fair

Copyright Clearance Center

March 5, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will host, “ Publishers, Copyright & AI: Taking Action ” at the 2024 London Book Fair on Tuesday, 12 March, 10:30 – 11:00am GMT in the Tech Theatre. An international panel of executives from leading scholarly publishers, including Claire Harper , Head of Global Rights & Licensing, Sage , and Sarah Fricker , Group Head of Legal, IOP Publishing , will address questions s

article thumbnail

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

article thumbnail

These 3 Changes Must Occur for Hospitals to See Greater ROI from Their AI Investments

MedCity News

Most health systems aren’t seeing a huge ROI from their AI investments yet. There are three changes that must happen in order for health systems to start seeing a greater ROI when it comes to AI deployments, according to Michael Kalishman, chief venture officer at Virginia-based Sentara Health.

article thumbnail

New BeiGene Head of Europe, Global Clinical Operations appointed

European Pharmaceutical Review

BeiGene has appointed Pilar de la Rocha as its new Head of Europe, Global Clinical Operations. The biotech’s new appointment underlines its commitment to advancing clinical development initiatives in the European region. The company highlighted that 35 percent of patients enrolled in its clinical trials are based in Europe. Pilar de la Rocha brings more than two decades of experience in oncology clinical development to the role, according to Beigene.

article thumbnail

UK NHS introduces new endometrial cancer immunotherapy

Pharmaceutical Technology

The UK NHS has introduced the new checkpoint inhibitor immunotherapy dostarlimab (Jemperli) for women with advanced endometrial cancer.

98
article thumbnail

Analytica 2024 in overview

European Pharmaceutical Review

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. Both national and international market leaders are represented, with a noticeable increase, particularly from China. Innovative startups and smaller companies show great interest in the fair, which has established itself as a springboard for new developments and products.

article thumbnail

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.

article thumbnail

Come to MedCity INVEST, Where You Could Meet Your Startup’s First Institutional Investor or a Future Portfolio Company!

MedCity News

The premier boutique healthcare investment conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago

article thumbnail

Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions

European Pharmaceutical Review

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. The agency declared that it has identified an increase in fraudulent and unreliable laboratory testing data within these submissions. It advised manufacturers and study sponsors for these products to “carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to th

Medical 83
article thumbnail

Novo Nordisk looks set to add another string to Ozempic bow

pharmaphorum

Novo Nordisk’s GLP-1 agonist Ozempic has shown efficacy in yet another indication, achieving a 24% reduction in kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD) in the FLOW trial.

81
article thumbnail

Spanish Audio Is Global Winner

Copyright Clearance Center

According to the latest report from dosdoce.com on audio publishing in Spanish-language markets, production and consumption is soaring.

article thumbnail

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.

article thumbnail

Ransom speculation as US reels from health cyberattack

pharmaphorum

As healthcare facilities and pharmacies try to recover from one of the most disruptive cyberattacks in US history, reports have emerged that the perpetrators may have received a hefty ransom payment.

article thumbnail

Alamar Biosciences and ALZpath Announce Collaboration Centered on Furthering Alzheimer’s Disease Research

Pharmaceutical Commerce

The pTau217 antibody helps pinpoint pathological changes related to the disease.

105
105
article thumbnail

Pharma’s Medicare counteroffers are all in, says HHS

pharmaphorum

HHS says all pharma companies affected by Medicare price negotiations have filed counteroffers, trumpeting the milestone as a sign the process is working

Pharma 80
article thumbnail

Womb condition checks could reduce cancer risk in endometrial hyperplasia

PharmaTimes

Women with atypical endometrial hyperplasia have an increased risk of developing cancer

87
article thumbnail

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

article thumbnail

Innovation as Strategy: Enabling life sciences of the future

pharmaphorum

Explore “Innovation as Strategy” framework, providing a guide for employing innovative strategies in life sciences. These expert panellists will reflect on what ‘Innovation as Strategy’ means to them, offering their perspectives, along with practical advice and real-world examples.

72
article thumbnail

Modernizing Insurance Processing: The Role of AI Technology

Referral MD

As we continue to embrace the digital age, technology has become integral to every aspect of our lives. What is role of technology in healthcare insurance today? Technology’s influence is pervasive, from communication to education, e-commerce travel to healthcare. However, the insurance industry, the backbone of our society, needs to adapt to rapid technological advancements.

article thumbnail

FDA clears first OTC glucose biosensor, from Dexcom

pharmaphorum

US adults who want to measure their blood glucose levels using a wearable biosensor will soon be able to buy one over-the-counter (OTC) from Dexcom

FDA 75
article thumbnail

Researchers develop brain-age prediction tool for diagnosis of neurological diseases

PharmaTimes

The non-invasive tool can also improve patient stratification and monitor disease progression

article thumbnail

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.