Tue.May 06, 2025

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Prasad’s FDA appointment pressures cell and gene therapy stocks

Bio Pharma Dive

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.

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Overcoming challenges in orphan drug development: From clinical trials to market

Pharmaceutical Technology

Developing orphan drugs involves navigating intricate regulatory landscapes, financial risks, and limited clinical data. To rise to these challenges, the biopharma industry continues to develop innovative strategies to bring vital therapies swiftly to rare disease patients.

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May 6, 2025: Registration and Abstract Submissions Open for 2025 Nudges in Health Care Symposium

Rethinking Clinical Trials

The Nudge Unit at Penn Medicine opened registration and abstract submissions for the 2025 Nudges in Health Care Symposium. The event is “focused on exploring the application of behavioral economics principles and nudges in healthcare settings.” The Nudge Unit is supported by Center for Health Care Transformation and Innovation and thePenn Center for Health Incentives and Behavioral Economics.

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Innovating Gastrointestinal Therapeutics: Science, Strategy and Insight

XTalks

Gastrointestinal (GI) disorders pose major challenges in modern healthcare. In the US, nearly 45 million adults suffer from nonerosive gastroesophageal reflux disease (GERD) , while more than 15 million receive prescription treatments for its erosive form. Nonerosive GERD shows typical reflux symptoms without visible esophageal damage, whereas erosive GERD causes clear injury to the esophageal lining.

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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

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US government exercises $144m option for smallpox/mpox vaccine contract

Pharmaceutical Technology

The options are for the freeze-dried version of Bavarian Nordics Jynneos, a formulation that allows easier stockpiling.

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Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously

Bio Pharma Dive

Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing obstacle to large acquisitions.

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Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines

Bio Pharma Dive

The appointment of Prasad as head of the FDA’s Center for Biologics Evaluation and Research sent shares in developers of vaccines and genetic medicines tumbling.

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Bristol Myers Squibb announces $40bn US investment plan over five years

Pharmaceutical Technology

Bristol Myers Squibb (BMS) plans to invest $40bn in the US over the next five years to bolster its research and manufacturing capabilities.

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Bluebird pleads for deal support; Unity, Mersana lay off staff

Bio Pharma Dive

Bluebird urged shareholders to back a take-private deal that could close imminently. Elsewhere, Unity Biotechnology began a strategic review and Mersana announced plans to cut more than half its workforce.

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Recursion axes drug programmes to streamline pipeline  

Pharmaceutical Technology

Recursion Pharmaceuticals has narrowed its drug development pipeline as it seeks to reduce costs and reprioritise resources.

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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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Chiesi partners with Wirral Primary Care to improve COPD detection

Pharma Times

New initiative aims to accelerate diagnosis and ease NHS pressures

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Pharma M&A deal value surges by 101% QoQ in Q1 2025 despite US political turbulence

Pharmaceutical Technology

Mergers and acquisitions (M&As) in the biopharmaceutical industry surged 101% in total deal value in the first quarter (Q1) of 2025 from $18.8bn in Q4 2024 to $37.7bn, according to leading data and analytics company GlobalDatas Pharmaceutical Intelligence Center Deals Database.

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Johnson & Johnson submits application for subcutaneous Rybrevan dosing

Pharma Times

Company seeks approval for new schedules to improve patient convenience

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Veraxa and OmniAb to develop bispecific ADC tumour programme

Pharmaceutical Technology

Veraxa Biotech has entered a joint discovery partnership with OmniAb for developing a bispecific antibody drug conjugate programme.

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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

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Follow the 340B Dollar: Senator Cassidy Exposes How CVS Health and Walgreens Profit as 340B Contract Pharmacies

Drug Channels

Two weeks ago, Senator Bill Cassidynow chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP)dropped a must-read, eyebrow-raising report on the out-of-control 340B Drug Pricing Program. (Link below.) The report reveals previously confidential information showing how billions are funneled to health systems and pharmacieswith manufacturers unable to follow the flow.

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GLP-1 receptor agonists poised to redefine treatment paradigms beyond diabetes and obesity

Pharmaceutical Technology

Glucagon-like peptide-1 receptor agonists (GLP-1RAs), once focused on treating diabetes and obesity, are now emerging as potential treatments for a broader range of chronic conditions, including metabolic dysfunction-associated steatohepatitis and Alzheimers disease.

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Lilly forges a $415m ALS alliance with UK biotech Alchemab

pharmaphorum

Eli Lilly has added another candidate to a growing pipeline of therapies for ALS, tapping Alchemab for an antibody sourced from 'resilient' patients

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FDA approves Selarsdi injection as interchangeable with Stelara

Pharmaceutical Technology

Teva and Alvotech have announced receipt of the US FDA approval to Selarsdi injection for use as an interchangeable with Stelara.

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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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PTC's Huntington study was positive. Why did its stock fall?

pharmaphorum

A potentially pivotal trial PTC Therapeutics' therapy for Huntington's disease met its primary endpoint, but there are questions about the data

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Swiss biotech sector’s R&D investment grew in 2024 despite global trends

Pharmaceutical Technology

Research and development (R&D) investment in the Swiss biotech sector grew in 2024, despite ongoing global funding struggles.

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The ins and outs of HEOR – A lever for global health

pharmaphorum

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Rob Abbott, CEO and executive director of ISPOR the leading professional society for HEOR globally about the ins and outs and trends of HEOR.

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Asembia 2025: Digital Health and Biosimilars Shape the Future of Pharmacy

Pharmaceutical Commerce

Blake Powers, CEO, medigi, explains how digital tools, AI, and automation are streamlining access to biosimilars and cell and gene therapies, signaling a shift toward more tech-enabled, patient-centric care.

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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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EU joins the bid to court beleaguered US scientists

pharmaphorum

The EU has announced a 500m to convince top scientific talent from around the world to relocate to Europe's "free and open" research environment

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Patient Services: A Marathon, Not A Sprint

Pharmaceutical Commerce

Rob Truckenmiller, CEO of PharmaCord, talks about the companys role in patient services, trends he sees shaping patient access to healthcare in the U.S., and a recent patient-centric merger.

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Pharma Industry Outlook: Trends Shaping the Future

Pharma Marketing Network

The pharma industry is undergoing a seismic transformation. As 2025 unfolds, traditional business models are giving way to data-driven innovation, personalized care, and integrated digital ecosystems. Stakeholders across the healthcare spectrum must not only adapt to changethey must anticipate it. Imagine steering a ship through unpredictable currents.

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Asembia 2025: Tracking Long-Term Outcomes Key to Advanced Therapy Value

Pharmaceutical Commerce

Fran Gregory, VP, emerging therapies, Cardinal Health, emphasizes the need for long-term outcomes tracking and robust health economic modeling to demonstrate the sustained value of advanced therapies and support future payment strategies.

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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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Co-developing companion diagnostics to connect patients with emerging therapies

pharmaphorum

Incorporating NGS technology early in the drug development process lays the foundation for CDx development, and taking a co-development approach helps ensure patients have access to emerging therapies as soon as they are approved, positively impacting cancer patient outcomes while minimising the risks from inappropriate treatment.

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How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing

Pharmaceutical Commerce

As the adoption of biologics rises, demand for home healthcare grows, and conditions like diabetes and autoimmune disorders become more prevalent, self-injectables are here to stay.

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Drug-Drug interactions : keep it up with challenges

Pharma Tutor

Drug-Drug interactions : keep it up with challenges admin Tue, 05/06/2025 - 16:08 Drug-Drug interactions are identified through a combination of clinical observation, scientific research, pharmacological knowledge, and the use of specialized tools. In clinical practice, healthcare providers assess the risk of interactions by reviewing a patients complete medication list, including prescription drugs, over-the-counter products, and supplements.

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Predicting Drug Market Potential

Drug Patent Watch

"The Future of Medicine is Not Just About the Cure, But Also About the Business of It. New research suggests that the success of a new medication is often determined long before it reaches the market. At DrugPatentWatch, we're taking a closer look at the data and uncovering the secrets to predicting a drug's market potential. From patent filings to clinical trial results, we're breaking down the key indicators that can make or break a new medication's success.

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