Wed.Apr 02, 2025

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April 2, 2025: The Greenlight Plus Trial and Preventing Childhood Obesity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K.

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Amneal and Shilpa introduce Boruzu in US for cancer treatment

Pharmaceutical Technology

Amneal Pharmaceuticals, along with Shilpa Medicare, has launched the new presentation of bortezomib, Boruzu.

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‘A cruel April Fool’s joke’: HHS layoffs characterized by confusion, errors

Bio Pharma Dive

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

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UK life sciences venture capital funding lags behind

Pharmaceutical Technology

At the BioTrinity Conference, experts champion government funding programmes to bridge gap the in UK venture capital financing.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Leqembi’s EU review drags on; Sanofi gets a new development head

Bio Pharma Dive

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of insolvency and Novartis hired a new top lawyer.

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The role of biosimilars in population health management initiatives

Drug Patent Watch

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?

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Transforming Biopharma Intelligence: Moving from Traditional Analysts to Direct Raw Data Platforms

Drug Patent Watch

The Future of Biopharma Intelligence: Why Direct Data Platforms are Revolutionizing the Industry As a biopharma professional, you're likely no stranger to the challenges of staying ahead in a rapidly evolving market. From navigating complex regulatory landscapes to keeping pace with the latest scientific breakthroughs, it's easy to get overwhelmed by the sheer volume of information at your fingertips.

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US uncertainty weighs on IPO market while UK innovation could benefit

Pharmaceutical Technology

Panellists at the OBN BioTrinity 2025 conference in London discussed how US uncertainty is impacting the biopharma environment.

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FDA device office hit in HHS layoffs

Bio Pharma Dive

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

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Organon acquires Actemra biosimilar’s US rights from Biogen

Pharmaceutical Technology

Organon has announced the acquisition from Biogen of US regulatory and commercial rights for intravenous infusion of Tofidence.

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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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Combating Autoimmunity: Vera Therapeutics CEO Dr. Marshall Fordyce Discusses Advancing IgAN Treatments — Episode 202

XTalks

In this episode, Ayesha spoke with Marshall Fordyce, MD, founder and CEO of Vera Therapeutics , a company focused on developing treatments for autoimmune diseases. Dr. Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a successful Phase II trial in IgA nephropathy.

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AIRNA secures $155m to bring RNA-candidate to clinic

Pharmaceutical Technology

The Series B funds will support the launch of a Phase I/II clinical trial for AIR-001 to advance its RNA editing pipeline.

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Four Revelations from Minnesota’s First 340B Transparency Report (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from December 2024. Its time to pay attention to the money behind the 340B curtain. Minnesota just released the industrys first ever mandated financial report on the 340B Drug Pricing Program.

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RFK Jr swings axe at US health agencies

Pharmaceutical Technology

Plans outlined by HHS Secretary Robert F Kennedy, Jr look set to target jobs at the US Department of Health & Human Services (HHS).

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

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NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma

Pharma Times

Advancing care for stage 3 or 4 Hodgkin lymphoma patients

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FDA accepts priority review of Apellis’ Empaveli sNDA for kidney diseases

Pharmaceutical Technology

Apellis Pharmaceuticals has announced US FDA acceptance of the sNDA and the granting of priority review status to Empaveli

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4basebio receives MHRA licence for synthetic DNA manufacture

Pharma Times

GMP certification enables 4basebio to supply DNA for clinical trials

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Third time not so lucky in J&J's bid to end talc liability

pharmaphorum

Johnson & Johnson's third attempt to use bankruptcy proceedings to settle lawsuits claiming its talc-based products harmed consumers has failed

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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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Pharma Pulse 4/2/25: Balancing Cost-Efficiency with Domestic Manufacturing Need, Making M3P Work for Your Pharmacy & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Death penalty sought for suspect in UnitedHealth CEO killing

pharmaphorum

Prosecutors in the US are seeking the death penalty for Luigi Mangione in connection with the assassination of UnitedHealth CEO Brian Thompson.

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Hubs East 2025: Understanding Copay Accumulators, Maximizers, and Alternative Funding Programs

Pharmaceutical Commerce

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Kimberly Westrich, chief strategy officer at the National Pharmaceutical Council, lays out the basics surrounding accumulators, maximizers, and AFPs.

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First drug backed for NHS use in untreated Hodgkin lymphoma

pharmaphorum

Takeda's Adcetris has become the first drug recommended for routine NHS use as a treatment for previously untreated late-stage Hodgkin lymphoma

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sometimes Alzheimer’s Strikes Early. This Experimental Drug May Help.

AuroBlog - Aurous Healthcare Clinical Trials blog

Alzheimer’s disease is usually associated with old age. But around 5%-10% of all Alzheimer’s cases occur in people under the age of 65. Early-onset Alzheimer’s disease progresses more rapidly and often strikes people in the prime of their lives. Treatment options remain limited.

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Study links 'bad cholesterol' to dementia

pharmaphorum

Reducing levels of LDL-cholesterol can reduce the risk of dementia by 26%, and statins could add to the benefit, according to a just-published study

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ACC 2025: GLP-1RAs may reduce incidence of AF/flutter and stroke in diabetic patients

Pharmaceutical Technology

T2D has been associated with an increased risk of CV mortality and GLP-1RAs are being increasingly used as a T2D and obesity treatment.

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Safeguarding the pharmaceutical supply chain

pharmaphorum

Tune into pharmaphorum podcast Episode 171a with Dean Alms of Aravo for how to best protect the pharmaceutical supply chain against extreme weather events.

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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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Marketing in Pharma: Strategies that work in 2025

Pharma Marketing Network

Introduction If the past few years have taught pharma marketers anything, it’s that agility, data, and digital-first thinking aren’t just buzzwordsthey’re survival tactics. Marketing in pharma has undergone a radical shift, propelled by digital transformation, patient-centric demands, and evolving regulatory landscapes. In 2025, the strategies that succeed are rooted in personalization, innovation, and real-time adaptability.

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Enabling Digitally Enhanced Care for Rare Diseases in Europe

pharmaphorum

Join the Chiesi webinar on enabling digitally enhanced care for rare diseases in Europe and learn about the latest advancements and strategies for improving healthcare for rare disease patients.

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Governmentally Recognized as Safe

FDA Law Blog

By Ricardo Carvajal & JP Ellison & Paul M. Hyman Thats a play on an old acronym, in service of a point. A few weeks ago, HHS released a press release stating that FDA had been directed to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.

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Hims & Hers Begins Selling Zepbound

Pharmaceutical Commerce

The telehealth company is offering Lillys branded form of tirzepatideapproved for weight losson its site for $1,899 a month, while Lilly also sells the GLP-1 via its LillyDirect platform.

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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