Fri.May 09, 2025

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HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines

Pharmaceutical Technology

HLS Therapeutics has signed an agreement with Esperion Therapeutics for commercialising Nexletol and Nexlizet in Canada.

Medicine 130
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Grand Rounds May 2, 2025: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study (Roland RJ van Kimmenade, MD, PhD)

Rethinking Clinical Trials

Speaker Roland RJ van Kimmenade, MD, PhD Cardiologist, Radboud University Medical Center Nijmegen, the Netherlands Slides Keywords Heart Failure; Fluids; Cardiology Key Points We are facing a pandemic of heart failure (HF), with an incidence of 1 20 cases of heart failure per 1,000 people. The incidence of HF is stable if not declining but mortality remains high, at about 15 30% after one year.

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Zevaskyn Gets FDA Nod as First Cell Therapy for Rare, Debilitating Skin Disease

XTalks

The FDA has granted approval to Abeona Therapeutics Zevaskyn (prademagene zamikeracel, also known as pz-cel), marking it as the first and only cell-based gene therapy approved for the rare skin disease recessive dystrophic epidermolysis bullosa (RDEB). The therapy is described as an autologous cell sheet-based gene therapy that acts as a skin graft.

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GSK reveals data behind linerixibat for PBC 'relentless itch'

pharmaphorum

GSK reveals the data behind its linerixibat for itching associated with autoimmune liver disease PBC as it anticipates first approvals for the drug.

Drugs 70
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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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Velocity Sites Help Deliver Promising Results in NEJM: Once-Weekly Semaglutide Shows Positive Affect on MASH, Liver Fibrosis

Velocity Clinical Research

Velocitys sites in Dallas, TX , and Staszw, Poland , enrolled patients in Novo Nordisks Phase 3 trial assessing semaglutides effect on participants with metabolic dysfunctionassociated steatohepatitis (MASH). Trial results were published in a recent New England Journal of Medicine article detailing the GLP-1 receptor agonists impact on liver fibrosis.

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Pharma still in waiting mode after UK-US trade agreement

pharmaphorum

Hopes that the UK-US trade agreement would give some clarity on the situation for pharmaceuticals proved optimistic.

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More Trending

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Vor Bio winding down as multiple biotechs downsize

pharmaphorum

Biotech pressures exposed as big job losses are announced at Vor Bio, IGM Biosciences, Rallybio, Insitro, and Korro Bio.

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Is the Industry Ready for the DSCSA?

Pharmaceutical Commerce

In the second part of his Pharma Commerce video interview, Michael Rowe, Two Labs senior director of DSCSA/serialization compliance services, comments on stakeholders overall preparedness for complying with the latest enforcement deadlines.

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AZ plots wider Imfinzi use in bladder cancer after trial win

pharmaphorum

AstraZeneca's run of positive trial results with its cancer therapies has continued with a win for its immunotherapy Imfinzi in early bladder cancer

Trials 59
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Follow These Regulations for Herbal Clinical Trials in India

ProRelix Research

AuthoritativeregulationsshapingHerbalClinicalTrialsinIndia,detailingAYUSHprotocols,CDSCOmandates,andGCPstandardstoupholdscientificrigorandregulatoryexcellence. India, the cradle of Ayurveda and centuries-old herbal traditions, is rapidly emerging as a global leader in evidence-based herbal medicine. With the increasing demand for natural therapies backed by […] The post Follow These Regulations for Herbal Clinical Trials in India appeared first on ProRelix Research.

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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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The value of a partner, globally and locally

pharmaphorum

With the FDA and EMA releasing their annual reports detailing novel drug approvals in 2024, a new pharmaphorum podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face in the year ahead.

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Medicaid cuts could have ‘drastic impact’ on providers

Bio Pharma Dive

Some providers may need to reduce services, lay off staff or close their doors if Congress enacts major cuts to the safety-net insurance program, experts say.

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Weight-loss drugs cut alcohol intake by almost two-thirds, research in Ireland suggests

Medical Xpress

Individuals who take liraglutide or semaglutide for weight loss reduce their alcohol consumption by almost two-thirds in four months, new research presented at the European Congress on Obesity (ECO 2025) has found.

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Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

Bio Pharma Dive

The big pharma will spend up to $250 million over the next eight years of the collaboration. Elsewhere, CRISPR Therapeutics unveiled new data and Vivo Capital raised funds.

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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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Combination of significant weight gain and late motherhood greatly increases risk of breast cancer, study finds

Medical Xpress

Women who experience significant weight gain after the age of 20 and either have their first child after the age of 30 or don't have children are almost three times more likely to develop breast cancer than those who give birth earlier and whose weight remains relatively stable, new research from the UK being presented at the European Congress on Obesity (ECO 2025) has found.

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5EU Q1 2024 versus 2025: Pricing shifts, HTA outcomes, and innovative drug trends

Pharmaceutical Technology

Globaldata's analysis focuses on three key indicators, which include HTA outcomes in the 5EU and the entry of newly priced innovative drugs.

Drugs 130
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The US has 1,001 measles cases and 11 states with active outbreaks

Medical Xpress

The U.S. surpassed 1,000 measles cases Friday, even as Texas posted one of its lowest counts of newly confirmed cases since its large outbreak began three months ago.

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FDA chief Martin Makary sets June deadline for genAI rollout

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has set an "aggressive" timeline to implement genAI across the agency by 30 June 2025.

Drugs 130
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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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FDA will allow three new color additives made from minerals, algae and flower petals

Medical Xpress

U.S. regulators said Friday that they would allow three new color additives made from natural sources to be used in the nation's food supply.

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NewBiologix licenses cell line technology to Recipharm Advanced Bio

Pharmaceutical Technology

NewBiologix has given a non-exclusive technology licence to Recipharm Advanced Bio to provide pharma companies access to Xcell-Eng-HEK293.

Licensing 130
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The greater a woman's BMI in early pregnancy, the more likely her child is to develop overweight or obesity, study finds

Medical Xpress

New research being presented at the European Congress on Obesity (ECO 2025) highlights the need to support women and their families with overweight or obesity to optimize their health and weight before they become pregnant.

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Bavarian Nordic shares rise 7% following strong Q1 for vaccine sales

Pharmaceutical Technology

Bavarian Nordic is successfully navigating a sentiment-changing vaccine landscape, posting Q1 revenues significantly up from Q1 2024.

Vaccine 130
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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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Unannounced FDA Inspections Expand Abroad: What This Means for Global Suppliers

XTalks

The FDA has announced it will expand surprise inspections at foreign manufacturing sites that produce foods, medicines and medical products destined for US consumers and patients. This builds on its Foreign Unannounced Inspection Pilot program previously conducted in India and China. Until now, overseas facilities have typically received advance notice often weeks while US-based manufacturers are more frequently subject to unannounced visits.

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Haya secures $65m in Series A funds to advance heart failure treatment

Pharmaceutical Technology

Haya Therapeutics has secured $65m in Series A funding to expedite the clinical development of HTX-001 for treating heart failure.

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Measuring What Matters

Pharmaceutical Commerce

Ways to reimagine pharmas operating model and KPIs for commercial success in an AI-driven future.

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Biosimilars: Unlocking access, closing the cost divide

pharmaphorum

Cost-related nonadherence (CRN) the act of skipping doses, splitting pills, or delaying refills to save money is a major issue among US adults with chronic conditions.

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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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Secrets of Pharmaceutical Market Access

Pharma Marketing Network

What does it take to bring a life-saving therapy to market and ensure patients can actually access it? Behind every successful drug launch lies a labyrinth of negotiations, pricing models, and payer strategies. Understanding the pharmaceutical market access process is crucialnot only for commercialization teams but for marketers and strategists looking to position their brands competitively.

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Pharma Pulse 5/9/2025: Teva Plots Thousands of Job Cuts as Restructuring Drive Enters 'Acceleration' Phase, Takeda to Invest $30B Into US Operations

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Healthcare Advertising That Works: Data-Driven Pharma Campaigns That Convert

Pharma Marketing Network

Is your healthcare advertising generating the conversions your pharma brand needs? In todays competitive, digitally saturated market, traditional messaging no longer cuts it. Precision targeting, performance insights, and adaptive content are essential to reach both healthcare professionals (HCPs) and patients effectively. Fortunately, the rise of data-driven strategies is helping marketers build more intelligent campaigns that truly convert.

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Hybrid Hub Models for the Patient Journey

Pharmaceutical Commerce

Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, outlines the recent shift in the patient services industry towards a hybrid hub model for in-house management and outsourced support.

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