Mon.Feb 24, 2025

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Kennedy’s MAHA agenda is tackling ‘conflicts of interest’ — and could take aim at FDA adcomms

PharmaVoice

Health agency job cuts and a newly-established MAHA commission leave many unanswered questions about potential reforms and impact on drug approvals.

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Pfizer names Patrizia Cavazzoni, former top FDA official, as chief medical officer

BioPharma Dive

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.

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FDA Updates: What Do the Latest Changes Mean for Generic Drug Approval?

Drug Patent Watch

Breaking News: FDA Updates - What Do the Latest Changes Mean for Generic Drug Approval? Hey there, fellow healthcare professionals and industry experts! I'm excited to share with you the latest updates from the FDA that could significantly impact the generic drug approval process. As you may know, the FDA has been working tirelessly to improve the efficiency and transparency of the generic drug approval process.

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Semaglutide shortage ends as FDA sets deadline for compounders

Pharmaceutical Technology

With Novo Nordisks blockbuster drugs Wegovy and Ozempic back in stock, copycat versions are no longer allowed for now.

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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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FDA brings back some fired device office staff

BioPharma Dive

An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

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More Trending

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Partnering for success in early phase clinical development

BioPharma Dive

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

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ICR researchers develop blood test to uncover how childhood tumours adapt

Pharma Times

It is hoped that the approach will lead to more targeted treatments for childhood cancers

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FDA clears first therapy for rare disease CTX from Mirum

pharmaphorum

Mirum Pharma's Ctexli has become the first FDA-approved therapy for ultra-rare disease cerebrotendinous xanthomatosis (CTX)

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Summit partners with Pfizer to study bispecific, ADC combinations

BioPharma Dive

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially landscape-changing combinations.

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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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Troubled gene therapy player bluebird sold for a song

pharmaphorum

At risk of defaulting on financial commitments, gene therapy firm bluebird bio has agreed to sell itself to private equity firms at a knockdown price.

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“Digital genocide”: BMJ post alleges patient data deletion amid DEI purge

Pharmaceutical Technology

In an anonymous post in the BMJ, the author claims that words relating to DEI could lead to grants being taken away.

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FDA looks at Opdivo/Yervoy in first-line colorectal cancer

pharmaphorum

The FDA has started a priority review of Bristol Myers Squibb's Opdivo and Yervoy as first-line therapy for MSI-H and dMMR colorectal cancer

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MeiraGTx seeks UK approval after gene therapy restores sight in children born blind

Pharmaceutical Technology

MeiraGTxs investigational gene therapy AAV-AIPL1 has improved the sight of 11 children who were born blind.

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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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Compounders cast adrift after semaglutide shortage ends

pharmaphorum

The FDA has said there is no longer a shortage in the US market for Novo Nordisk's GLP-1 agonist semaglutide, ending sales of compounded forms.

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EC authorises Celltrion’s Avtozma for multiple indications

Pharmaceutical Technology

Celltrion has secured marketing authorisation from the EC for Avtozma, a biosimilar to Chugai Pharmaceuticals RoActemra (tocilizumab).

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FDA Approves First Treatment for Rare Lipid Storage Disease Cerebrotendinous Xanthomatosis

PharmaTech

Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.

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Pharma Pulse 2/24/25: Picking Markets for a Global Launch Strategy, Semaglutide Holds Promise in Reducing Alcohol Cravings & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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Teva and Alvotech launch ustekinumab biosimilar injection in US

Pharmaceutical Technology

Teva Pharmaceuticals and Alvotech have announced the US launch of Selarsdi (ustekinumab-aekn) injection, a biosimilar to J&Js Stelara.

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Understanding Polypharmacy

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Tom Dorsett, CEO, RazorMetrics, explains the concept of polypharmacy, including how prominent it is in the United States today.

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FDA approves Mirum’s Ctexli for cerebrotendinous xanthomatosis

Pharmaceutical Technology

Mirum Pharmaceuticals Ctexli (chenodiol) has gained US Food and Drug Administration (FDA) approval for treating adults with CTX.

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Antidepressants linked to faster cognitive decline in dementia

World Pharma News

New research suggests that antidepressants can accelerate cognitive decline in people with dementia. At the same time, some drugs appear to be less harmful than others, which can help doctors make better treatment decisions, according to the study published in BMC Medicine. Antidepressants are often used to relieve symptoms such as anxiety, depression, aggressiveness, and sleep disturbances in dementia sufferers.

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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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Sanofi, Teva add to case for new bowel disease drug

BioPharma Dive

Detailed results presented at a medical congress help reinforce analyst expectations the drug, called duvakitug, will be competitive with other Crohn’s, colitis medicines in testing.

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Lifileucel Approval Paves the Way for Personalized Minimally-Invasive T-Cell Therapies

Pharmacy Times

The FDAs accelerated approval of lifileucel (Amtagvi; Iovance Biotherapeutics) marks a major milestone in immunotherapy for metastatic melanoma, building on decades of research in tumor-infiltrating lymphocyte therapy.

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Mirum drug for rare genetic disease gains FDA approval

BioPharma Dive

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with Travere Therapeutics.

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Adopting Flexible Strategies to Combat Capacity Shortages

PharmaTech

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

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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.