Fri.Apr 11, 2025

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STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’

STAT

In an unexpected move, the U.S. Food and Drug Administration announced plans this week to reduce — and possibly replace — animal testing with other methods for developing certain medicines in a bid to lower R&D costs and, eventually, the prices for prescription drugs. The agency will encourage researchers to use computer modeling and artificial intelligence to predict how a drug will perform, as well as organs-on-a-chip, which are miniaturized devices that mimic organs and tiss

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Pharma’s manufacturing moment: Where companies are making the biggest moves

PharmaVoice

The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.

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Doctors remove pig kidney from an Alabama woman after a record 130 days

STAT

WASHINGTON — An Alabama woman who lived with a  pig kidney  for a record 130 days had the organ removed after her body began rejecting it and is back on dialysis, doctors announced Friday — a disappointment in the ongoing quest for animal-to-human transplants. Towana Looney  is recovering well from the April 4 removal surgery at NYU Langone Health and has returned home to Gadsden, Alabama.

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NICE recommends new combination breast cancer drug

European Pharmaceutical Review

The National Institute For Health and Care Excellence ( NICE )s has recommended a new combination treatment for advanced breast cancer patients. AstraZenecas Truqap (capivasertib) in combination with fulvestrant is indicated as a treatment option for around 1,100 UK adults with hormone receptor (HR)-positive HER2-negative breast cancer with certain genetic mutations.

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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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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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SEO Marketing Strategies that work in Pharma

Pharma Marketing Network

In a highly regulated industry like pharmaceuticals, standing out online can feel like navigating a maze. Unlike retail or tech brands, pharma companies must balance compliance with creativity while communicating with multiple audiences. This is where SEO marketing strategies become essentialallowing brands to boost visibility, earn trust, and support both HCP and patient journeys without violating regulatory guidelines.

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What could Kinnock's vision for pharmacy 'reform' look like?

The Pharmacist

Reform to the community pharmacy sector must come alongside investment, the pharmacy minister Stephen Kinnock has said. But what could this look like in practice? Ahead of the 3.073bn deal for the sector announced last week, Mr Kinnock told press: 'With all investment, reform has to come together with investment'. And in the light of […] The post What could Kinnock's vision for pharmacy 'reform' look like?

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Imbria secures $57.5m to advance ninerafaxstat through Phase IIb nHCM trial

Pharmaceutical Business Review

Spearheaded by Deep Track Capital, this funding round saw participation from new investors, including Catalio Capital Management, Cytokinetics, and AN Ventures, alongside contributions from current backers SV Health Investors and RA Capital Management. The placebo-controlled, double blind, placebo-controlled, randomised trial is set to commence in the second quarter of this year, with expectations for topline data by late 2026.

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FDA plans to phase out animal testing for some drugs

BioPharma Dive

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

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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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FDA to phase out animal testing with AI and lab-based models

Pharmaceutical Technology

The FDA has announced plans to phase out animal testing in the development of monoclonal antibodies and other drugs.

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FDA Approves Biocon Biologics’ Bevacizumab Biosimilar

Big Molecule Watch

On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN .JOBEVNE is a recombinant humanized monoclonal antibody that acts as a vascular endothelial growth factor inhibitor. It is indicated for the treatment of certain types of colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epit

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AstraZeneca’s oral breast cancer drug Truqap greenlit for NHS use

Pharmaceutical Technology

The twice daily tablet represents a significant step forward for patients with advanced breast cancer.

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The use of FTWZs has risen by 20 to 25% every quarter after the pandemic

Express Pharma

With close to three decades of experience in setting up logistics parks at ports, across MENA and India, you have seen the evolution of pharma logistics. What are the key drivers for the current transformation of the pharma and medical device logistics sector in India? And where do free trade warehousing zones (FTWZs) fit into these business imperatives?

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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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Alzheon Alzheimer's hopes dented by trial readout

pharmaphorum

Alzheon has been left sifting through data from a failed Alzheimer's trial for crumbs of evidence that its oral therapy may have some efficacy

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Amgen says Imdelltra extended survival; Parker Institute adds new leaders

BioPharma Dive

The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

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Novartis plans $23bn manufacturing, R&D spend in US

pharmaphorum

Novartis has announced a massive investment in manufacturing and R&D facilities in the US so it can make "100% of its key medicines" there

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Novartis to Expand US-Based R&D and Manufacturing

PharmaTech

The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.

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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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RFK Jr unorthodox vaccine views on show in interview

pharmaphorum

Robert F Kennedy Jr's controversial views on vaccines were on display this week during an interview that touched on delays to a COVID-19 shot review

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Pharma Pulse 4/11/25: Long-Term Sustainability for Diverse Trial Initiatives, Payers Consider Policy Options for GLP-1 Access & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA plans to phase out animal testing for antibodies

pharmaphorum

The FDA has said it intends to reduce or replace animal testing of some medicines, including monoclonal antibodies, with other methods.

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Hubs East 2025: Building a Thriving Culture

Pharmaceutical Commerce

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Kimberly Westrich, chief strategy officer at the National Pharmaceutical Council, comments on another presentation that has caught her eye at the conference.

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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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Pill that can slow breast cancer cleared for NHS use

pharmaphorum

AstraZeneca's oral drug Truqap will soon be available for people with advanced breast cancer via the NHS in England, as long as testing is available

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BDD Opens GMP Manufacturing Facility in Scotland

PharmaTech

Development of the state-of-the-art facility was made possible by a 2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

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Novartis to Invest $23 Billion in US Manufacturing and R&D Over Five Years

PharmExec

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

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Can AI replace medical writers? Experts say not immediately

Pharmaceutical Technology

AI tools are faster at drafting clinical trial documents, but human writers remain indispensable for logical reasoning.

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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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From Prescription to Patient: Four Ways to Increase Speed to Therapy

Pharmaceutical Commerce

The key strategies for reducing or eliminating post-prescription abandonment.

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FDA Grants Full Approval to Bayer’s Vitrakvi for NTRK Gene Fusion-Positive Solid Tumors

PharmExec

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors.

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What Your Data Can Tell You About Illicit Trade Risk

Pharmaceutical Commerce

Why taking proactive stepsand combing the right data sourcesis critical to informed decision-making in risk management.

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