Thu.May 29, 2025

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STAT+: AI-based mammography is here, and it has a trust problem

STAT

Radiologists interpret more than 40 million mammograms in the United States every year. In 2025, AI tools to help detect or diagnose possible cancer will be applied to millions of them.  As the Food and Drug Administration has cleared several AI algorithms to analyze mammograms, some imaging centers are adopting them en masse. RadNet, which owns more than 400 U.S. radiology practices, says it deploys its own AI algorithm in 600,000 mammograms every year.

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7 common compliance issues faced by the pharmaceutical industry in India

Express Pharma

Indias pharmaceutical industry is one of the largest in the world, playing a crucial role in both domestic healthcare and global drug supply. But behind the innovation and scale lies a web of regulations that pharma companies must follow closely. Compliance in this sector is non-negotiable; it impacts everything from manufacturing and labour to environmental practices and global trade.

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Trending Sources

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Opinion: How we beat anti-vaccination bills in North Dakota

STAT

Misinformation spreads faster than prairie fire, often with as much destruction. Right now, state legislatures nationwide are debating bills based on erroneous beliefs that would strip away public health protections. Calls to increase vaccine exemptions in schools and daycare centers, for example, have contributed to measles outbreaks in Texas and elsewhere.

Vaccines 286
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Merck, Daiichi pull approval application for ADC in lung cancer

BioPharma Dive

A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.

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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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HHS cancels $766m bird flu vaccine contract with Moderna

Pharmaceutical Technology

The HSS has terminated a contract previously awarded to Moderna to help advance a vaccine candidate targeting bird flu.

Vaccines 111
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New technology could enhance CAR T therapy manufacture

European Pharmaceutical Review

Research has illustrated a potential new device for harvesting T cells that could improve the cost-effectiveness of manufacturing CAR T-cell therapy and make the cancer immunotherapy more accessible to patients. In development by investigators in the US, the device, called capture and glow (CAPGLO), captures T cells via a magnetic field and makes them visible using glowing fluorescent tags.

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Lumanity and Parker Institute partner to support delivery of new immunotherapies

Pharma Times

The alliance combines Lumanitys commercial and development strategy capabilities with PICIs translational research expertise

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Data sets up filing of new GSK antibiotic this year

pharmaphorum

GSK has said it will file its oral carbapenem antibiotic tebipenem HBr for approval before the end of this year as a treatment for complicated UTIs

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Ryvu Therapeutics appoints Justyna Żółtek to management board

Pharmafile

Ryvu Therapeutics has promoted Justyna tek, chief people officer, to its management board. The appointment reflects the companys focus on organisational development as it continues to advance a pipeline of oncology programmes. tek joined Ryvu in 2021, leading the creation of its human resources (HR) function during a period of operational growth. Since then, she […] The post Ryvu Therapeutics appoints Justyna tek to management board appeared first on Pharmafile.

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Moderna's $760m-plus flu vaccine contracts are nixed by HHS

pharmaphorum

HHS cancels funding for Moderna's pandemic flu vaccine development in a move viewed by some as an attack on mRNA technology

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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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iTeos to shut down following $2bn GSK-partnered TIGIT asset failure

Pharmaceutical Technology

iTeos will look to distribute its cash reserves to shareholders, along with proceeds raised from selling pipeline assets.

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Axtria Ignite 2025: Leading in an Agentic Era

pharmaphorum

Join us at Axtria Ignite 2025 on 4th to 5th June to explore and lead in the agentic era. Learn from industry experts and leaders shaping the future of business.

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The medtech IPO window is finally open. Or is it?

BioPharma Dive

After a three-year drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of activity.

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FDA Grants Interchangeability Designation to Hadlima

Pharmaceutical Commerce

The designation allows pharmacists to substitute it for Humira without prescriber approval (per state law), which expands patient access in the process.

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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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Solid tumours: CAR-T therapies’ Waterloo

Pharmaceutical Technology

Expanding the reach of CAR-T therapeutics could unlock promising new treatment possibilities for solid tumour patients.

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MSD and Daiichi Sankyo pull HER3-DXd's FDA filing

pharmaphorum

MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.

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The impact of drug pricing and reimbursement on the pharmaceutical industry

Pharmaceutical Technology

Drug pricing and reimbursement constraints are a major concern for the pharmaceutical industry. In order to balance generating revenues with ensuring that a new medicine reaches the largest possible group of patients, companies must consider price and reimbursement across multiple countries, act early in the development cycle and ensure the evidence required to support their commercial strategy is built into their development plans.

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Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant non-small cell lung cancer

World Pharma News

Bayer announced that the investigational compound sevabertinib (BAY 2927088) has been granted Priority Review status by the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy.[1] Sevabertinib is an oral, small molecule, tyrosine kinase inhibitor (TKI).

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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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Regeneron to deploy Telesis Bio’s Gibson SOLA at R&D facilities

Pharmaceutical Technology

Telesis Bio has announced a licensing agreement with Regeneron, enabling the latter to deploy the Gibson SOLA platform at R&D facilities.

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ASCO 2025: Adding Elranatamab to Daratumumab, Lenalidomide Induces Durable Responses in Newly Diagnosed Multiple Myeloma

Pharmacy Times

Elranatamab shows promising efficacy and manageable safety in transplant-ineligible newly diagnosed multiple myeloma patients, highlighting its potential as a treatment option.

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FDA approves Eton’s application for hydrocortisone oral solution

Pharmaceutical Technology

Eton Pharmaceuticals NDA for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval.

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Childhood Cancer Survivors at an Increased Risk of Developing CKD, Study Finds

Pharmacy Times

The investigators suggest that early detection and treatment of chronic kidney disease (CKD) in childhood cancer survivors may decrease late complications and mortality.

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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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EC approves BMS’ nivolumab SC formulation for solid tumours

Pharmaceutical Technology

The EC has granted approval for the new subcutaneous (SC) formulation of Bristol Myers Squibbs (BMS) Opdivo (nivolumab)

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HER2 and HER3 in NSCLC: The Latest ADC Data and NCCN Guideline Updates

Pharmacy Times

Corrine Stahura, PharmD, and Sophia Gilardone, PharmD, BCOP, discuss recent clinical trial data and evolving guideline recommendations for HER2- and HER3-directed antibody-drug conjugates (ADCs) in nonsmall cell lung cancer (NSCLC), highlighting differences in efficacy, safety, and patient selection criteria.

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Intellia filing spurs safety concerns over CRISPR drug

BioPharma Dive

Shares lost a quarter of their value after the company disclosed, in a regulatory filing, a life-threatening adverse event in a study testing one of its gene editing treatments in a deadly heart condition.

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Epcoritamab-bysp Yields Long-Term Disease Remission in Patients with Relapsed, Refractory Large B-Cell Lymphoma

Pharmacy Times

Epcoritamab shows impressive long-term remission rates in relapsed large B-cell lymphoma, highlighting its potential as a key treatment option.

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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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HHS terminates Moderna contract to develop bird flu vaccine

BioPharma Dive

The funding was meant to help the U.S. prepare for pandemics triggered by avian flu strains, but now leaves the future of Moderna’s program uncertain.

Vaccines 124
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Pneumococcal 15-Valent Conjugate Vaccine Provides Heightened Protection Against Certain Serotypes Compared With PCV13

Pharmacy Times

V114, a 15-valent pneumococcal conjugate vaccine (PCV), provided better protection against serotypes 22F and 33F compared with 13-valent PCV (PCV13).

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White House acknowledges problems in RFK Jr.’s MAHA report

STAT

WASHINGTON — The White House will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human Services Secretary  Robert F. Kennedy Jr. , which decried America’s food supply, pesticides and prescription drugs. Kennedy’s wide-ranging “Make America Healthy Again” report , released last week, cited hundreds of studies, but a  closer look by the news organization NOTUS  found that some of those studies did not

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Study Reveals Impact of RSV on the Heart

Pharmacy Times

New research highlights the significant cardiovascular risks associated with RSV, emphasizing the need for vaccination to protect vulnerable populations.

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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.