Thu.Jun 19, 2025

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1 Rather than representing a radical break from established practice, the document builds on decades of scientific and regulatory experience, proposing that – under certain well-defined conditions – the demonstration of bio-similarity might rely more heavily on advanced analytical characterisation and pharmacokinetic (

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 1

Express Pharma

INTRODUCTION: INDIA’S STERILE MANUFACTURING UNDER THE REGULATORY SPOTLIGHT Genesis and growth of the Indian pharma industry The Indian pharmaceutical industry traces its origins to the early 20th century, when local entrepreneurs began to challenge the dominance of foreign firms in the British colonial era. Following independence in 1947, the Indian government prioritised healthcare self-sufficiency by cultivating a strong domestic drug manufacturing base.

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New Drugs, New Decisions: How Pharmacists Are Guiding the Future of Hematologic Care

Pharmacy Times

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From pilots to impact: What it really takes to scale GenAI in pharma

pharmaphorum

Discover the essential factors required to successfully scale GenAI in the pharmaceutical industry, from pilot programmes to impactful implementation. Gain insights on the challenges and strategies for successful integration.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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CAR T and Beyond: The Expanding Pipeline and Promise of Cell Therapies

Pharmacy Times

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AI Generated Marketing Campaigns: Is Pharma Ready?

Pharma Marketing Network

The intersection of artificial intelligence and pharmaceutical marketing is creating new waves of innovation. In 2025, AI generated marketing campaigns are no longer experimental. They are being deployed to personalize content, predict engagement, and automate outreach. But is the pharma industry truly ready to embrace these capabilities? Table of Contents What Are AI Generated Marketing Campaigns?

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GPhC launches new strategic plan to ‘empower’ pharmacists

The Pharmacist

The pharmacy regulator has launched a new five-year strategic plan focused on ‘empowering’ pharmacists to provide trusted, safe and effective care. Chair of the All Party Parliamentary Group (APPG) on pharmacy, Steve Race MP, hosted a Parliamentary event to mark the launch, where pharmacy minister Stephen Kinnock MP stressed that pharmacists are ‘key’ to the […] The post GPhC launches new strategic plan to ‘empower’ pharmacists appeared first on The Pharmacist.

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OPC 2025: Early and Metastatic GI Cancers See Practice Changing Trial Results

Pharmacy Times

At the 2025 Oncology Pharmacists Connect (OPC) meeting, Courtney Cavalieri, PharmD, BCOP, presented clinical trial findings in gastrointestinal (GI) cancers—including colon, gastric, pancreatic, and metastatic colorectal cancer—that highlight the expanding role of immunotherapy and targeted treatments.

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Alembic Pharmaceuticals receives USFDA EIR for API-III facility in Gujarat

Express Pharma

Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API-III manufacturing facility located in Karakhadi, Gujarat. The USFDA inspection was carried out from 17 March 2025 to 21 March 2025. The receipt of the EIR signifies that the inspection has been successfully closed by the regulatory authority.

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OPC 2025: Advancing Precision Oncology Through Pharmacy-Led Innovation

Pharmacy Times

At the 2025 Oncology Pharmacists Connect (OPC) meeting, Mya Tran, PharmD, BCOP, highlights the clinical promise, operational challenges, and evolving role of pharmacists in implementing precision medicine and genomics-driven cancer care.

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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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Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: DCI’s 2025 Update and Competitive Outlook (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for tomorrow's live video webinar: What’s Next for Retail Pharmacy: Data, Debate, and Disruption. I’ll be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research, and President of 3 Axis Advisors. Click here to see the original post from April 2025. It's time for Drug Channels ’ annual update of vertical integration among insurers, PBMs, specialty pharmacies, and healthcare services within U.S. drug channels.

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Abbott and MSD Pharmaceuticals partner to distribute oral anti-diabetic medicines in India

Express Pharma

Abbott and MSD Pharmaceuticals have announced a strategic distribution agreement for MSD’s oral anti-diabetic treatment portfolio in India. The agreement covers Sitagliptin, its fixed-dose combination Sitagliptin/Metformin, and its extended-release formulation. These medicines are marketed under the brand names Januvia, Janumet, and Janumet XR. Under the terms of the agreement, Abbott will handle distribution for the entire portfolio across India, leveraging its nationwide presence to continue m

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NICE concludes decision for two Alzheimer’s treatments

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended against approving Leqembi (lecanemab) and Kisunla (donanemab) to treat mild cognitive impairment or mild dementia caused by Alzheimer’s, in its final draft guidance. “We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for new evidence to be submitted,” stated Helen Knight, Director of medicines evaluation at

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CNS innovator oligonucleotide licensing value up 339% from £2bn in 2024

Pharmaceutical Technology

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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What is a Pharma Ad Exchange?

Pharma Marketing Network

Imagine a high-speed auction house that matches digital ad space with targeted pharmaceutical ads in milliseconds. That’s essentially what an Ad Exchange is—and for pharma marketers, it’s reshaping the way campaigns reach healthcare professionals (HCPs) and patients. In a world where precision and privacy matter more than ever, pharma ad exchanges offer a streamlined, scalable, and data-driven way to deliver the right message to the right audience.

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Nitisinone Becomes First and Only FDA-Approved Treatment for HGA in Adults With AKU

Pharmacy Times

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Behind the Headlines, Episode 19: CGT Cost Pressures, BioNTech’s CureVac Move, and Spain’s CAR-T Model

PharmaTech

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Gilead Sciences’ Yeztugo receives approval from US FDA for HIV

Pharmaceutical Technology

The FDA has approved Gilead Sciences' injectable product, Yeztugo (lenacapavir), as a pre-exposure prophylaxis (PrEP) against HIV.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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KFSHRC and Germfree to launch first modular ATMP manufacturing campus in Saudi Arabia

Pharmafile

King Faisal Specialist Hospital & Research Centre (KFSHRC) has announced a landmark partnership with Germfree Laboratories to develop Saudi Arabia’s first fully integrated modular advanced therapy medicinal product (ATMP) manufacturing campus. Unveiled at BIO 2025 in Boston, US, the facility will be located on KFSHRC’s Riyadh campus and marks a major milestone in the country’s […] The post KFSHRC and Germfree to launch first modular ATMP manufacturing campus in Saudi Arabia appeared fi

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BASF Opens GMP Manufacturing Facility in Michigan

PharmaTech

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eXmoor and Signadori Bio enter cell therapy partnership

Pharma Times

Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs eXmoor and Signadori Bio enter cell therapy partnership by Emily Kimber | 19th Jun 2025 | News Signadori is advancing a platform designed to overcome the challenges of treating solid cancers eXmoor Pharma and Signadori Bio have entered into a partnership aimed at advancing a gene-modified monocyte-derive

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Feeling Overworked and Run Down? How to Communicate With Management

The Script

Learn how pharmacy professionals can raise workload concerns effectively—using facts, professionalism, and solutions—to protect well-being and patient safety.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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AstraZeneca enters strategic collaboration with CSPC Pharmaceuticals focused on AI-enabled research

World Pharma News

AstraZeneca has entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group Limited. Working together on high priority targets, the collaboration aims to advance the discovery and development of novel oral candidates, with the potential to treat diseases across multiple indications.

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How new medicines become available on the NHS

The Pharmacist

New medicines can transform the treatment and prevention of disease, improving – and in many cases saving – lives. But no health system has unlimited resources. This creates a political and technical challenge for governments and health systems which must decide which drugs to make available and to whom. Few areas of health policy are […] The post How new medicines become available on the NHS appeared first on The Pharmacist.

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Actio gains $66m to advance small molecule therapeutics pipeline

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

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Navigating EGFR Mutations and ALK Fusions in Early-Stage Non-Small Cell Lung Cancer

Pharmacy Times

News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice in Focus: Oncology Pharmacy Practice in Focus: Health Systems Pharmacy Careers All Publications About the Publications Author Submission Submit to

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Dismay but little surprise as NICE rejects Alzheimer's drugs

pharmaphorum

Eli Lilly and Eisai's hopes of making their Alzheimer's disease therapies available to NHS patients in England have been knocked back once again

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Eli Lilly and Eisai’s Alzheimer’s drugs denied NHS use due to high costs

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

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Precision, speed, impact: Evolving mass spectrometry for medical science

pharmaphorum

Join us for an insightful conversation with Melissa Sherman from MOBILion as we discuss the future of molecular science and the impact of mass spectrometry. Tune in to this podcast interview for an in-depth look at the latest innovations in the field.

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EIT Health Ireland–UK Expands European Network with Three New Members

PharmaTech

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.