Fri.Nov 01, 2024

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Opinion: STAT+: Precision medicine can’t fulfill its promise without better diagnostics

STAT

It’s been 13 years since  the term “precision medicine” was coined , and its promise — the ability to treat the right patient with the right medicine in the right dose at the right time — remains as compelling as ever. But we haven’t yet fulfilled this promise. Why? In my previous role as head of precision medicine at Novartis, I realized the biggest challenge to making precision medicine a reality was not the development of the medicines themselves

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Green manufacturing in pharma: Sustainable oligonucleotide production on an industrial scale

Express Pharma

Oligonucleotides are at the forefront of modern medicine and have emerged as powerful tools in treating diseases in recent years. Oligonucleotides – short DNA or RNA molecules that host a range of applications in genetic testing, research, and forensics – have seen a marked growth in significance as therapeutics. As their clinical application widens, methods of production must be robust to ensure demand is met.

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A setback for the tau approach to Alzheimer’s

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Morning! Today, we discuss Madrigal’s impressive launch of its MASH drug Rezdiffra, see psychedelics player Compass Pathways shed 30% of its staff, and more.

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What does this week's Budget mean for pharmacists in general practice?

The Pharmacist

In the Autumn Budget this week, chancellor Rachel Reeves committed to providing an additional £22.6bn to the ‘day-to-day health budget’ – including £100m to use on upgrades to 200 general practice estates in England. The budget also outlined minimum wage increases which may have a knock-on impact across the board, but are currently unfunded in […] The post What does this week's Budget mean for pharmacists in general practice?

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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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The quest for quality continues

Express Pharma

Quality was once again in the spotlight at two recent industry meets. While regulators kept their sights on raising the compliance bar, industry chiefs pledged adherence to these codes. Not surprisingly, most speakers focused on the importance of trust. At the Indian Pharmaceutical Alliance’s (IPA) virtual 9th Advanced Good Manufacturing Practices (GMP) Workshop Dr Rajeev Raghuvanshi, Drugs Controller General of India, CDSCO, Government of India commented, “At the heart of the pharmaceutic

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A sickle cell cure exists. But patients need more than just gene therapy.

PharmaVoice

Almost a year after two historic approvals, Pfizer is pulling a sickle cell disease treatment from the market, and the outlook for patients feels shakier. But there’s still hope in the pipeline.

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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

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Novo, with new results, to seek approval for obesity drug in MASH

BioPharma Dive

The Phase 3 findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren't a "silver bullet" for MASH, one analyst argued.

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NICE trumpets new standard for health AI evaluations

pharmaphorum

With artificial intelligence technologies for healthcare on the rise, UK health technology assessment (HTA) agency NICE has published an economic evaluation standard that it says will help inform coverage and reimbursement decisions.

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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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Drug Repurposing: Unlocking access to rare solutions

Express Pharma

In the marathon of drug development, where billions of dollars and over a decade of research are the norm, drug repurposing is quietly reshaping the landscape. This approach is particularly beneficial for rare diseases, where the treatment options are woefully limited. For conditions affecting fewer than 200,000 individuals, traditional development is economically daunting and repurposing emerges as a pivotal strategy, offering faster, affordable solutions for conditions that have long been left

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GSK enters agreement to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline

World Pharma News

GSK plc (LSE/NYSE: GSK) and Chimagen Biosciences (Chimagen), a privately held biotechnology company, announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialise CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases.

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Verastem Oncology submits NDA for ovarian cancer treatment

Pharmaceutical Technology

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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2024 PharmaVoice 100s: Cancer Care Visionaries

PharmaVoice

Leaders who envision a world without cancer through oncology innovation.

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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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Report: Medicare Part D Premiums Rise an Average of 11% Nationwide

Pharmaceutical Commerce

Analysis finds that while basic Part D coverage costs have decreased by 4%, mid- and high-tier plans have seen hikes of 4% and 21%, respectively.

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PharmaVoice 100s: Cancer Care Visionaries

PharmaVoice

Leaders who envision a world without cancer through oncology innovation.

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Top 10 rare disease pharma sees 10.4% rise in therapy start

Outsourcing Pharma

A new case study released by AllazoHealth reveals that a leading rare disease pharmaceutical company achieved a 10.4% increase in therapy initiation, driven by AI-enabled patient outreach and personalized communications.

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Eisai, Biogen eye 2025 approval for Leqembi autoinjector

pharmaphorum

Eisai and Biogen complete their rolling application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi

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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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Abzena’s advanced drug development showcased at CPHI Milan

Outsourcing Pharma

At CPHI Milan 2024, Abzena showcased its latest innovations in cell line development and ADC manufacturing, featuring the advanced AbZelectPRO platform and ThioBridge linker technology.

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US court upholds Avadel’s narcolepsy drug approval amid exclusivity battle 

Pharmaceutical Technology

The US District Court upholds the FDA’s approval of Avadel’s Lumryz, dismissing Jazz’s challenge over market exclusivity for its own drug.

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Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Pharmacy Times

ASHP investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of respondents reporting that they experienced a shortage.

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Regeneron battles Wall Street uncertainty; Madrigal extends fast launch of MASH drug

BioPharma Dive

Regeneron shares continued to decline on growing concerns about Eylea’s future. Elsewhere, new details emerged about Lundbeck’s Longboard buyout and PTC continued a quixotic quest.

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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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Pharma Pulse 11/1/24: Targeting Patients Without Cookies, Personalized Diabetes Care Approaches & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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EMCrit 387 – Emergency Department Charting for Legal Protection and Patient Safety

EMCrit Project

Chart to protect yourself and your patients! EMCrit Project by Scott Weingart, MD FCCM.

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Top Challenges for Pharma Marketing in 2025

Pharma Marketing Network

The world of pharma marketing is changing rapidly, and 2025 will be no exception. For pharma marketing executives, adapting to these shifts isn’t just about keeping up—it’s about staying ahead. From digital transformation and personalized marketing to compliance and competition, the upcoming years will demand flexibility and innovative thinking. So, what will be the top challenges in 2025, and how can pharma marketers tackle them?

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FDA Rare Disease Innovation Moves Forward

PharmaTech

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

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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.