Wed.Jan 29, 2025

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Will European PFAS ban disrupt pharma supply chains?

Pharmaceutical Technology

A proposed ban on PFAS chemicals is being challenged over concerns about potential supply chain disruption in the pharmaceutical industry.

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FDA clears use of Ozempic to protect kidney health

Bio Pharma Dive

The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, which hasn’t yet proven it can improve outcomes in kidney disease.

Drugs 252
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January 29, 2025: Early Lessons From ARBOR-Telehealth, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Richard Skolasky and Kevin McLaughlin of Johns Hopkins University will present “Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned.” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clini

Trials 174
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BioAge drops obesity drug; Akero, 89bio cash in on MASH data

Bio Pharma Dive

BioAge scrapped the drug at the center of its $198 million initial public offering last year. Elsewhere, Akero and 89bio raised $600 million combined and Allakos laid off staff.

Drugs 154
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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RFK Jr. denies being anti-vaccine during intense Senate confirmation

Pharmaceutical Technology

The potential secretary for Health and Human Services has been forced to defend his previous anti-vaccine stances at his senate hearing.

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Ozempic is first GLP-1 drug FDA-approved for kidney disease

pharmaphorum

Novo Nordisk's Ozempic has become the first drug in the GLP-1 class to be cleared to prevent worsening kidney disease in type 2 diabetics

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Lyfegen partners EVERSANA on pricing, access resource

pharmaphorum

Lyfegen and EVERSANA have joined forces to help pharma companies navigate an increasingly complex global drug pricing and access environment

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FDA expands Enhertu approval to include HER2-ultralow breast cancer patients

Pharmaceutical Technology

Enhertu is projected to reach $13.9bn in sales by 2030, according to GlobalDatas Pharma Intelligence Center.

Sales 147
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Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

The Hidden Costs Behind Your Generic Medications: What's Driving the Price? As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. But the truth is, there's more to it than meets the eye. The cost of producing generic drugs is influenced by a multitude of factors, and understanding these dynamics can help us better appreciate the affordability of these e

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Lyndra Therapeutics appoints Adam Sayer new CEO and president

Pharmaceutical Technology

Lyndra Therapeutics has announced the immediate appointment of Adam Sayer as its new president and CEO, succeeding Jessica Ballinger.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA Greenlights Monthly IV Dosing for Alzheimer’s Med Leqembi

XTalks

The FDA has approved a new dosing regimen for Biogen and Eisais Leqembi (lecanemab-irmb), introducing once-every-four-weeks intravenous (IV) maintenance dosing for patients with early Alzheimers disease. Patients can transition to the monthly dose after completing 18 months of biweekly infusions. The new dosing regimen aims to maintain the therapys benefits while improving convenience for patients and caregivers.

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Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD

Pharmaceutical Technology

The approval solidifies Novo Nordisks Ozempic as the most broadly indicated GLP-1RA in the US.

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New Zepbound TV Commercial Inspires ‘Change’

XTalks

Eli Lilly launched a 75-second TV commercial called Change in November 2024 to promote the companys GLP-1 obesity drug Zepbound (tirzepatide). The Zepbound TV commercial highlights the transformative journey of weight loss, encouraging viewers to embrace change and consider Zepbound as a catalyst for achieving their health goals. The ad focuses on the theme of change to resonate with individuals seeking a meaningful and lasting impact on their health.

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FDA RMAT designation for Beacon’s retinitis pigmentosa treatment

Pharmaceutical Technology

The FDA has granted RMAT designation to Beacon Therapeutics gene therapy, laru-zova, for treating X-linked retinitis pigmentosa (XLRP).

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Troubled 23andMe is exploring a sale of the business

pharmaphorum

Genetic testing specialist 23andMe has launched a strategic review that could result in a sale of the company.

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Looking for Clues about FDA Under RFK Jr.

FDA Law Blog

By John W.M. Claud & JP Ellison The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention, Kennedys portfolio will be vast.

Vaccine 59
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The future is LIVE marketing – and that matters more than ever

pharmaphorum

Discover why live marketing is the future, and why it matters now more than ever. Explore the latest trends, strategies, and tips for successful live marketing campaigns.

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Upperton Pharma Solutions Finalizes Construction of Sterile Manufacturing Plant

Pharmaceutical Commerce

The 7,000 square-foot GMP facility will provide formulation development support, along with analytical testing services.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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RFK cousin delivers broadside ahead of confirmation hearing

pharmaphorum

RFK Jr is unfit to lead the Department of Health and Human Services (HHS), according to members of his own family.

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Challenges Facing Pharma Supply Chains

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, outlines the technological obstacles that lie ahead for the industry this year.

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EMA abandons X in favour of rival Bluesky

pharmaphorum

The EMA has abandoned X for Bluesky, saying Elon Musk's social media platform "no longer suits our communication needs.

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Pharma Pulse 1/29/25: USP Calls for Pharmacists to Volunteer, Regulatory Response to Abuse-Deterrent Drugs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Drugs 59
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Advancing Digital Approaches in Alzheimer’s Research and Care ft. Sarah Averill Lott, DiMe and Diane Stephenson, Critical Path for Parkinson

XTalks

In this episode, Ayesha spoke with Sarah Averill Lott, MPH, CPH, Research Lead at Digital Medicine Society (DiMe) and Diane Stephenson, PhD, Executive Director at the Critical Path for Parkinson (CPP) at the Critical Path Institute. DiMe is a global non-profit and a professional home for digital medicine that aims to drive the broad adoption of digital approaches to advance medicine and public health.

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Redefining Patient Recruitment for Modern Research: The Power of a Utilizing a Comprehensive Database

My Local Study

In the fast-paced world of clinical research, time is of the essence. Every delay in patient recruitment pushes back timelines and increases costs. Our team understands this challenge and offers a solution: a dedicated, regularly maintained database of highly motivated research volunteers ready to be matched to your study. This isn’t just a list of.

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Top Pharmaceutical Trends Shaping the Future of Pharma Marketing in 2025

Pharma Marketing Network

Introduction The pharmaceutical industry is transforming at lightning speed. In 2025, pharmaceutical trends are redefining how brands connect with healthcare professionals (HCPs), patients, and stakeholders. Marketers must adapt to cutting-edge technology, personalized engagement, and regulatory shifts to stay ahead. But what exactly is shaping the future of pharma marketing this year?

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To protect sciences and pharma in an RFK Jr era, put consumer education first

pharmaphorum

In an era where science and pharma face challenges, prioritising consumer education is essential. Discover how to safeguard these industries in America, particularly in light of the influence of figures like RFK Jr.

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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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FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease

XTalks

The FDA has approved Novo Nordisks Ozempic (semaglutide) for reducing the risk of kidney failure, progression of kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). The approval marks Ozempic as the first GLP-1 receptor agonist (GLP-1 RA) authorized in a kidney disease indication. It also marks the third FDA approval for Ozempic, which has become a global blockbuster as a treatment for type 2 diabetes and off label use for weight loss.

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15th World Clinical Biomarkers & Companion Diagnostics Summit Europe

pharmaphorum

The 15th World Clinical Biomarkers & Companion Diagnostics Summit Europe organized by Hanson Wade brings together experts in the field to discuss the latest advancements and challenges in biomarker research. Learn more about this event here.

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Sonnet BioTherapeutics secures EU patent for FHAB technology

Pharmaceutical Technology

Sonnet BioTherapeutics has received a patent from the European Patent Office (EPO) for its fully human albumin binding (FHAB) technology.

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Overcoming barriers for global CGT adoption

pharmaphorum

Learn about the challenges and strategies for overcoming barriers to the global adoption of cell and gene therapies (CGT) in this informative article.

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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.