Wed.May 07, 2025

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STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list

STAT

A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from a shortages list kept by the agency. The move means that patients will no longer have access to cheaper versions from compounding pharmacies.

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Patent box tax incentives pharmaceutical innovation

Drug Patent Watch

"The Patent Box Tax Incentive: A Game-Changer for Pharmaceutical Innovation? As the pharmaceutical industry continues to drive groundbreaking research and development, a lesser-known tax incentive has emerged as a key catalyst for innovation. The Patent Box tax regime, introduced in the UK in 2013, has been hailed as a success in fostering a culture of R&D and entrepreneurship.

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STAT+: Flatiron Health veterans raise $25 million for AI tool to forecast drug toxicity

STAT

In January, San Francisco’s Union Square was bustling with hordes of drug developers and investors, pounding the pavement on their way from meeting to meeting. But Rohan Ganesh, an investor at the VC firm Obvious Ventures, wasn’t among them. He only agreed to hear one company’s pitch during this year’s J.P. Morgan Healthcare Conference.

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Novo Nordisk cuts 2025 outlook due to compounding-hit Wegovy demand

Pharmaceutical Technology

Novo Nordisk has cut its sales and profits forecasts for 2025 due to lower demand in the US for blockbuster weight loss and diabetes drugs.

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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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New CBER Director Appointed

PharmaTech

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

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Gilead’s Entry Inhibitor for Chronic Hepatitis Delta Demonstrates Durable Virologic Suppression Post-Treatment

PharmExec

Results from the Phase III MYR301 trial show that 36% of patients who achieved undetectable hepatitis delta virus levels when treated with bulevirtide maintained suppression for nearly two years.

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Landmark UK-India trade deal insufficient for life sciences, says industry body

European Pharmaceutical Review

The UK and India have agreed a major trade deal, however it does not provide sufficient support the UK pharmaceutical industry, according to the Association of the British Pharmaceutical Industry (ABPI). While the UK government considers the agreement to be the UKs largest and most economically significant bilateral trade deal since its EU exit in 2020, the industry body argued that it does not address key areas such as intellectual property protections for innovators within the Indian market.

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Health equity can be a competitive advantage: What pharma leaders need to know

pharmaphorum

As NICE begins to incorporate health equity into drug reimbursement decisions, forward-looking pharmaceutical companies have a chance to lead aligning innovation with access drivers and gaining a competitive edge in a changing global landscape.

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FDA grants RMAT status to Opus Genetics’ OPGx-LCA5 gene therapy

Pharmaceutical Technology

The US FDA has granted regenerative medicine advanced therapy (RMAT) designation to Opus Genetics gene therapy OPGx-LCA5

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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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Pharma Marketing Strategies That Actually Drive Results

Pharma Marketing Network

In an era where attention spans are shorter and healthcare stakeholders are increasingly digital-first, executing pharma marketing strategies that truly deliver ROI is both a challenge and a necessity. How do pharmaceutical brands cut through the clutter, earn HCP trust, and engage patients effectively? The answer lies in combining proven fundamentals with innovative tools and omnichannel integration.

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Sarepta shares fall amid FDA’s CBER appointment and weak Elevidys sales

Pharmaceutical Technology

Sareptas stock dropped by 26% after the FDA named a vocal critic of its gene therapy programme to lead its biologics division.

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FDA grants fast track status to Alterity’s multiple system atrophy treatment

Pharmaceutical Business Review

The fast-track application included top-line data from the double-blind randomised Phase II clinical trial, which showed efficacy on the modified Unified Multiple System Atrophy Rating Scale (UMSARS)I alongside preclinical data confirming that the agent is a low to moderate affinity iron chaperone. ATH434, which acts as an iron chaperone, is aimed at inhibiting the aggregation of pathological proteins associated with neurodegeneration.

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AAPS National Biotechnology Conference 2025: AAV Vector Production

PharmaTech

BioPharm International sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

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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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Biofrontera and Almirall Launch Social Media Campaign for Actinic Keratosis

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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European biotechs must understand US culture while seeking funding

Pharmaceutical Technology

At a time when investment has been low in biotech, establishing and maintaining good relationships with investors is vital.

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Acyclovir Versus Valacyclovir – What’s the Difference?

Med Ed 101

When treating herpes simplex virus (HSV) or varicella-zoster virus (VZV), two antiviral agents commonly used are acyclovir and valacyclovir. While both medications are effective, understanding their pharmacokinetic profiles, dosage forms, and clinical uses can help healthcare providers make the best choice for each patient. In this blog post, I will highlight the most important differences […] The post Acyclovir Versus Valacyclovir – What’s the Difference?

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Carnie Wilson Teams with Neurocrine Biosciences for TD Awareness Campaign

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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Expediting parallel drug approval pathways is challenging, but rewarding

Pharmaceutical Technology

At the Swiss Biotech Day 2025, which took place on 5-6 May in Basel, a panel of experts discussed three drug approval schemes.

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IVIG Can Cause Kidney Function Decline, Thromboembolism in Patients With Dermatological Conditions

Pharmacy Times

Intravenous immunoglobulin (IVIG) treatment for dermatologic conditions shows effectiveness but poses risks of kidney decline and thromboembolism, necessitating careful monitoring.

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EC approves AstraZeneca’s Calquence combo to treat MCL

Pharmaceutical Technology

The European Commission (EC) has approved AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) combo.

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UPMC's Innovative Approach to Heart Failure Care: Collaboration and Patient/Member-Centered Care Management

Pharmacy Times

UPMC enhances care for patients with heart failure through integrated pharmacy and cardiology team collaboration.

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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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Discovery explains Long COVID breathing problems

World Pharma News

Groundbreaking research from the University of Virginia School of Medicine has revealed crucial new insights into the immune systems of COVID-19 survivors, particularly those struggling with persistent breathing issues. The study shows that these patients have distinct changes in their immune system that link to the severity of their lung damage. This discovery holds promise for developing targeted treatments for the lung complications of Long COVID.

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Low-Dose Chlorthalidone Granted FDA Approval for Treatment of Adults With Hypertension

Pharmacy Times

The 12.5-mg dose tablet enhances hypertension treatment options and reduces adverse effects for patients.

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SK Pharmteco Debuts New cGMP Plasmid Suite

Pharmaceutical Commerce

The move bolsters the CDMOs commitment to cell and gene therapy by incorporating advanced manufacturing and fill-finish capabilities.

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Asembia AXS25: Emotional Support Transforms Specialty Pharmacy Patient Care

Pharmacy Times

Specialty pharmacy experts discuss how emotional support, addressing patient loneliness, and peer-to-patient programs can significantly improve medication adherence and patient care.

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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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Episode 1024: Adjuvant Midodrine Lowers Norepinephrine Dose But Not Length of Stay in Patients With Septic Shock

Pharmacy Joe

In this episode, Ill discuss the use of adjuvant midodrine in patients with septic shock. Episode 1024: Adjuvant Midodrine Lowers Norepinephrine Dose But Not Length of Stay in Patients With Septic Shock Subscribe on iTunes , Android , or Stitcher Using midodrine to wean ICU patients off of vasopressors is a common strategy and one that I have used in my practice and discussed in previous episodes.

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Expert: Navigating the Next Decade of Market Growth and Innovation for Biosimilars

Pharmacy Times

Dracey Poore explores the future of biosimilars, emphasizing the need for increased adoption.

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From Thema4 to TH5: The Evolution of Fedegari’s Autoclaves

PharmaTech

An article describing the technological advancement from one process controller to the new one.

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