Fri.Jul 26, 2024

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STAT+: How Pfizer’s grand gene therapy ambitions crumbled

STAT

A decade ago, Pfizer began investing heavily in gene therapy, bringing in experimental treatments for a range of genetic diseases, pumping $800 million into “state-of-the-art” manufacturing facilities and announcing its intention to become an “industry leader” that would deliver “one-time, transformative therapies” for rare diseases.

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Citius’ first FDA decision date is approaching — and its CEO has millions on the line

PharmaVoice

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

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STAT+: European regulators say Alzheimer’s therapy Leqembi should be rejected

STAT

LONDON — European regulators on Friday said that an Alzheimer’s therapy from Eisai and Biogen should be rejected, again diverging from their U.S. counterparts on a medicine for a condition where treatments are desperately needed. In a statement, the regulators said that the benefits of Leqembi did not outweigh the risks of potentially dangerous side effects.

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Study reveals blood proteins predict risk of developing many diverse diseases

Pharma Times

Researchers predicted the onset of 67 diseases, out-performing current standard models

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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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Morning Rounds: Three new bird flu cases in humans brings total to 13 in U.S.

STAT

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. I’m Brittany Trang, STAT health tech reporter and your new Friday morning host.

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New gut microbiome atlas could offer better treatment for digestive disorders

Pharma Times

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR

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BREAKING: Over 423,000 Pharmacy First consultations delivered in first three months

The Pharmacist

Some 423,310 Pharmacy First consultations were delivered in the first three months of the service, official figures from the NHS Business Service Authority (NHSBSA) have revealed. A total of 9,976 community pharmacies claimed payments for the service, although the number of those claiming on a monthly basis in February, March and April appears to be […] The post BREAKING: Over 423,000 Pharmacy First consultations delivered in first three months appeared first on The Pharmacist.

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Opinion: Medtech compliance — not regulation — is stifling innovation

STAT

“Regulation is stifling innovation” seems to be a prevailing opinion among medtech leaders who believe the Food and Drug Administration’s rules are slowing medical device advancements — especially when it comes to software. I couldn’t disagree more. As someone who has led artificial intelligence (AI) and machine learning (ML) efforts at Amgen, I’ve seen firsthand how vital these regulations are for keeping patients safe.

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In shock move, EU panel rejects Alzheimer's drug Leqembi

pharmaphorum

CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits

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The worst for Dexcom may not be over

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. We’ve made it to the end of the week! I don’t know about you, but it’s felt like an especially long week for me. It’s probably cause of all the news that we will get into right now.

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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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AZ joins call for new UK PM to back Oxford-Cambridge hub

pharmaphorum

Leading figures from industry and academia, including AstraZeneca, have urged UK PM Keir Starmer to turn the Oxford-Cambridge region into the "crown jewel" of his industrial growth plan

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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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Eisai selects Medidata’s Clinical Data Studio to enhance clinical trial efficiency

Express Pharma

Medidata , a Dassault Systèmes brand and provider of clinical trial solutions to the life sciences industry, announced Eisai Inc the US pharmaceutical subsidiary of Tokyo-based Eisai Co, as one of the first customers to harness its recently announced AI-driven Medidata Clinical Data Studio. Eisai Inc aims to leverage this innovative data experience to gain control over its clinical data, enable the execution of scalable and complex clinical trials, and enhance patient experience.

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5 strategies for biopharma to optimise patient recruitment in clinical trials

pharmaphorum

Discover 5 effective strategies for biopharma companies to optimize patient recruitment in clinical trials. Learn how to enhance recruitment processes and increase patient participation.

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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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NovaLead’s patented repurposed drug gets CDSCO nod for DFU patients in India

Express Pharma

NovaLead Pharma announced that the drug regulator in India, CDSCO has approved their patented repurposed drug for the treatment of Diabetic Foot Ulcer (DFU). DFU is one of the most prevalent complications caused by chronic diabetes. The approval of NovaLead’s patented repurposed drug is significant because DFU is the leading cause of lower limb amputations globally, with about 100,000 annual incidences in India alone.

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Health Innovators - Steve Damon

pharmaphorum

Discover the innovative work of Steven Damon, the CEO of Micron Biomedical, a company specialising in microneedle technology for improved healthcare delivery. Learn about his cutting-edge innovations in the field.

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Scottish Government 'monitoring' payment system issues

The Pharmacist

The Scottish Government has said it is 'aware' of issues following the introduction of a new payment system for community pharmacies, and has been assured that any incorrect payments have been or are being 'rectified'. And it said it was engaging with stakeholders as it continued to monitor the situation. Issues with the Data Capture […] The post Scottish Government 'monitoring' payment system issues appeared first on The Pharmacist.

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Creative review: The Cannes Lions trends that pharma needs to know about

pharmaphorum

Discover the top 7 trends from the Cannes Lions Festival that pharma professionals should be aware of. Stay ahead of the game with these creative insights.

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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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Pharma Pulse 7/26/24: Talent Management Strategies for Post-Milestone Growth, Dispensing Medication for Muslims & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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How Cure51’s AI breakthroughs are turning cancer into a manageable disease – an insider’s look

Outsourcing Pharma

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

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Nearly half of UK adults 'unaware' of Pharmacy First, survey suggests

The Pharmacist

Almost half (46%) of UK adults were unaware of Pharmacy First around three months into the service being available in England, a survey has shown. However nearly three-quarters (73%) thought that pharmacists should be able to update medical records with any advice or treatment supplied – up from 65% last year. The survey was conducted […] The post Nearly half of UK adults 'unaware' of Pharmacy First, survey suggests appeared first on The Pharmacist.

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Is Chiral Switching Still Relevant in Today’s Pricing Control Scenario?

Drug Patent Watch

Chiral switching, the practice of developing a single enantiomer from a previously approved racemic drug, has been a significant strategy in the pharmaceutical industry for decades.

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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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A new therapeutic target offers a promising pathway for multiple sclerosis treatment

World Pharma News

Researchers from Kyushu University have identified a potential therapeutic target for the treatment of advanced multiple sclerosis (MS), a potentially disabling condition associated with the central nervous system. In their latest study, conducted using an experimental mouse model of MS, they explored the role of connexin 43 (Cx43), a protein involved in cellular communication and cardiac function, and examined whether targeting this protein with specific blockers could improve MS symptoms.

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Revolutionary Alzheimer's drug donanemab approved – what does this mean for the future of care?

Outsourcing Pharma

The approval of donanemab marks a significant breakthrough in Alzheimer's treatment, promising transformative changes in patient care and research.

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Pfizer's haemophilia B gene therapy gets EU green light

pharmaphorum

Pfizer's haemophilia B gene therapy is approved in EU as Durveqtix, becoming the first alternative to CSL Behring's Hemgenix

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Leqembi voted down by European regulators

BioPharma Dive

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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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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STADA and Alvotech Announce Launch of UZPROVO® in Europe

Big Molecule Watch

On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved ustekinumab biosimilar to STELARA® in Europe, is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis. As we previously reported, Alvotech and STADA announced that the European Commission issued a marketing authorization for AVT04 in January 2024, and Alvotech

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Bristol Myers’ beat completes strong week of pharma earnings

BioPharma Dive

All five large pharmaceutical companies to report earnings this week raised either their profit or revenue guidance for the year.

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AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA

Pharmafile

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation. ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau). It has been shown to induce a strong polyclonal antibody response against Tau aggregation, thereby potentially reducing the pathological […] The post AC Immune’s pTau-targeting immunotherapy awarded Fast

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Two biotechs cut staff; AbbVie weathers biosimilar threat

BioPharma Dive

Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

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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.