Thu.Jul 20, 2023

article thumbnail

Novo Nordisk, Eli Lilly and Boehringer Ingelheim back bill to bring obesity drug coverage to Medicare

Fierce Pharma

Despite the widespread hype surrounding new and powerful obesity medicines, the drugs are still out of reach for many Americans who could benefit. | Despite the widespread hype surrounding new and powerful obesity medicines, the drugs are still out of reach for many Americans who could benefit. A group of lawmakers is working to change that.

Medicine 246
article thumbnail

Why the Pandemic Was a Turning Point for Nurses Flexing Union Power

MedCity News

Nurse unions and labor experts agree that the pandemic was a turning point that catalyzed nurses to fight for improved working conditions and overall better treatment from their employers. By negotiating new contracts with their employers, unions are working hard to both uphold patient safety and mitigate the nursing field’s debilitating workforce shortage.

Safety 98
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

Sandoz doubles down on biosimilars with $90M Slovenia site where it plans to hire 200

Fierce Pharma

Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest. | Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest. Its latest move follows a separate $400 million pledge to build a plant in the country.

220
220
article thumbnail

Covid is Still With Us. What Does That Mean for Your Brain?

MedCity News

We may not fully understand the link between Covid-19 and Alzheimer’s, but we already have the scientific research and tools to address people’s fears, support their cognitive health journey, and reverse the increase of Alzheimer’s.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Fierce Pharma Asia—Eisai's subcutaneous Leqembi study; Astellas' IRA lawsuit; and GSK's Taiwan recall

Fierce Pharma

After a recent study of Eisai's subcutaneous Leqembi formulation, the company is touting its "promising" results. | Eisai showed off "promising" results from a modeling and bioavailability study of its subcutaneous Leqembi formulation. Astellas joined the growing list of drugmakers taking on the Inflation Reduction Act with legal action.

Pharma 215
article thumbnail

Healthcare Spending Burden Is Higher for Medicare Households than Non-Medicare Households

MedCity News

On average, Medicare households spent 15% of their total spending on health-related expenses in 2021, versus 7% for non-Medicare households, according to a new KFF report.

More Trending

article thumbnail

How a ‘Costco Model’ for Health Care Supply Chain Presents a Best Bet for Value

MedCity News

By reimagining health care supply chain as a centralized, high-value distribution and product selection and procurement model, hospitals and health systems can more effectively reach their goals for expense reduction while driving substantial improvements for patients and team members alike.

article thumbnail

J&J's Darzalex stays on its upward trajectory as company adds $1B to annual sales projection

Fierce Pharma

With another quarter of strong sales from multiple myeloma drug Darzalex, Johnson & Johnson has boosted its revenue guidance for 2023.

Sales 186
article thumbnail

HCA, Tenet Saw Increased EBITDA in Q1 While Nonprofit Hospitals Continued to Struggle

MedCity News

The nation’s two largest for-profit hospital chains — HCA and Tenet — increased their EBITDA as salary and benefit obligations became less burdensome in Q1. Unsurprisingly, the story for nonprofit hospitals is a bit different. For this class of health systems, the stress associated with labor costs is subsiding, but operating margins are having a difficult time bouncing back, according to a new Moody’s report.

article thumbnail

After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version

Fierce Pharma

Right on the heels of an FDA approval for the closely watched Alzheimer's disease drug Leqembi in an intravenous dose, Eisai is touting "promising" findings that the company says support the case f | Right on the heels of an FDA approval for the closely watched Alzheimer's disease drug Leqembi in an intravenous dose, Eisai is touting "promising" findings that the company says support the case for a subcutaneous version.

FDA 148
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

Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor

MedCity News

Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent.

Safety 90
article thumbnail

FTC, DOJ propose updated merger guidelines, signaling more scrutiny around M&A deals

Fierce Pharma

As the Federal Trade Commission (FTC) scrutinizes two large biopharma mergers, the antitrust agency and the Department of Justice (DOJ) have laid out updated merger guidelines in a bid to slap down | The 13 updated principals proposed by the FTC and the DOJ point to tougher merger reviews. This comes as the FTC scrutinizes two blockbuster biopharma mergers.

Biopharma 146
article thumbnail

A leading CRO’s chief exec on why a ‘brave new world’ of clinical research is here

PharmaVoice

Peter Benton, co-CEO of Worldwide Clinical Trials, explains how the rise of the mid-sized pharma company has changed drug R&D.

Leads 98
article thumbnail

Former Merck VP Nirdosh Jagota settles with SEC on insider trading charge

Fierce Pharma

Merck’s $1.9 billion acquisition of Pandion Therapeutics was a major score for those with stock in the Massachusetts biotech. | The SEC has settled with former Merck Vice President Nirdosh Jagota who allegedly used insider information to make $39,660 on his purchases of stock in Pandion Therapeutics before the biotech was sold to Merck for $1.9 billion in 2021.

144
144
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

Peterson Center on Healthcare Launches $50M Institute To Assess Digital Health Solutions

MedCity News

The Peterson Health Technology Institute will function as an “independent evaluator” of digital health solutions. It will analyze solutions’ clinical effectiveness, how they’re affecting healthcare costs, their ability to improve health equity, and their privacy and security capabilities.

article thumbnail

Asian countries prioritise rare disease market access amid stark disparities

Pharmaceutical Technology

Ahead of APEC’s "Rare disease vision 2025" deadline, Asian countries are working at different speeds towards improving drug market access.

article thumbnail

Genentech to reveal new data for ocular biologic

European Pharmaceutical Review

Late-breaking post-hoc data on Vabysmo ® (faricimab-svoa), the first bispecific antibody (bsAb) approved for treating the eye, is set to be revealed at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting. The bsAb biologic is being assessed as a treatment for wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

article thumbnail

NIH funds $2m AI project for predicting cancerous lesions

Pharmaceutical Technology

The National Cancer Institute funded Enspectra Health to develop deep learning algorithms to predict which skin lesions are cancerous.

75
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

FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products

PharmaTech

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

article thumbnail

Autonomous PAT with digital twin integration reported

European Pharmaceutical Review

Research published in Processes has reported the first successful establishment, validation and integration of a digital twin with process analytical technology (PAT) operated autonomously for biologics manufacturing. In the study, this was illustrated on alkaline pDNA lysis of Escherichia coli ( E. coli ) using aqueous two-phase extraction (ATPE) with and without cell debris separation.

article thumbnail

Boost Your Freelance Business: Proven Strategies to Increase Online Sales Fast

Contrarian Sales Techniques

Hey there, fellow freelancers! Ever found yourself wondering how to increase online sales fast in our digital world? You're not alone. As freelancers, mastering the art of selling online is crucial to our success. In this post, I'll share some proven strategies that can help give your online sales a much-needed boost. Understanding the Freelancer's Digital Market Before we dive into strategies, let's set the stage by understanding our marketplace.

Sales 52
article thumbnail

The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

As proven by recent regulatory approvals sweeping the cell and gene therapy industry, particularly within Europe and the US, these pioneering treatments have demonstrated great capacity in helping to resolve hard-to-treat diseases. The Alliance for Regenerative Medicine (ARM) stated in a 2022 report that adeno-associated viral vector (AAV) is the primary vector in ongoing gene therapy trials.

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

Meet Our Mentor: Bryan Stewart

MedTechVets

JULY 20 – We were proud to interview MedTechVet Academy Mentor, Bryan Stewart. Bryan is the Founder and CEO of HDO Health and the Director at Victory Strategies. After transitioning out of the military, he has had a successful 20-year career in health care. At HDO Health, he is working hard to commercialize a specialty junctional tourniquet, the HDO Health Journiquet™, to help prevent people from bleeding to death from traumatic junctional wounds. “I have always been passionate about mento

article thumbnail

The transformative potential of AI in healthcare part I: opportunities and challenges for payers

Clarify Health

Healthcare stakeholders from all corners of the industry agree that artificial intelligence (AI) will play a pivotal role in transforming our sector. From diagnosing diseases with greater accuracy to creating personalized treatment plans to automating burdensome administrative tasks, the technology has seemingly innumerable uses for providers, payers, life sciences, pharma, and other healthcare organizations.

article thumbnail

Top Telehealth Takeaways from the 2024 Proposed Medicare Physician Fee Schedule

Nixon Gwilt Law

When the COVID-19 Declaration of a Public Health Emergency (the “PHE”) ended on May 11, 2023, we saw Congress extend some telehealth flexibilities introduced during the PHE and curtail others. Now, in the first proposed Medicare Physician Fee Schedule (“MPFS”) since the PHE ended, CMS is clearing up some lingering unanswered questions, with a particular focus on flexibilities established in the 2023 Consolidated Appropriations Act (“2023 CAA”).

article thumbnail

Sandoz invests $90m to build a biosimilar centre in Slovenia

Pharmaceutical Technology

The centre is planned for completion in 2026, along with plans to build a $400m biologics manufacturing plant.

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

Novartis Acquires DTx Pharma in Deal Worth Up to $1 Billion

PharmaTech

Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.

Pharma 52
article thumbnail

Grifols announces phase 3 progress for Albutein

PharmaTimes

Therapy has the potential to decrease mortality rates in patients with decompensated cirrhosis - News - PharmaTimes

article thumbnail

WHO director-general calls out critics of planned pandemic accords

Pharmaceutical Technology

WHO’s director-general addresses further action to improve childhood immunisations globally upon the release of new data.

52
article thumbnail

UCB announces EMA bimekizumab verdict

PharmaTimes

In two studies the therapy demonstrated improvements when compared with the placebo - News - PharmaTimes

62
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.