Fri.Dec 06, 2024

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STAT+: European regulators approve $16.5 billion deal for Novo Holdings to buy Catalent

STAT

The European Commission on Friday unconditionally approved a controversial deal in which Novo Holdings, the parent company of Novo Nordisk, one of the largest pharmaceutical companies, would pay $16.5 billion for Catalent, a leading contract drug manufacturer. By taking this step, the executive arm of the European Union removed a significant obstacle to a deal that has generated debate over the extent to which competition in the pharmaceutical industry may be hindered.

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NICE to review tirzepatide roll-out in three years, as limited NHS launch announced

The Pharmacist

NICE has accepted a request from NHS England to slow down the roll out of weight-loss drug tirzepatide, reserving eligibility for those with the highest clinical need at first. For the first three years of the drug being available on the NHS in England, access will be limited to 220,000 patients, after which point the […] The post NICE to review tirzepatide roll-out in three years, as limited NHS launch announced appeared first on The Pharmacist.

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Don’t Ignore Erectile Dysfunction

Compounding Pharmacy of America

Erectile dysfunction (ED) is often misunderstood as simply a sexual health concern, but it can signify much more. While many men experience occasional difficulties with sexual performance, persistent ED can be an early warning sign of serious underlying health issues such as cardiovascular disease, diabetes, or hormonal imbalances. Addressing ED is not just about improving […] The post Dont Ignore Erectile Dysfunction appeared first on Compounding Pharmacy of America.

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Award winner calls on government to stop ‘abandoning’ pharmacy

The Pharmacist

A superintendent pharmacist who has been recognised for saving a womans life says he wished the government better understood the impact the community pharmacy sector makes and stopped taking it for granted. Mohsin Raza, director of operations for Wellbeing Pharmacy, picked up a prestigious patient safety award at the annual Independent Pharmacies Association (IPA) awards […] The post Award winner calls on government to stop abandoning pharmacy appeared first on The Pharmacist.

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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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Why AI Advances in CGT Require Getting Data Right

Pharmaceutical Commerce

Addressing the bottlenecks in cell and gene therapy manufacturing through a well-designed artificial intelligence approach is essential to avoiding data siloes.

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FDA Releases Guidance on Accelerated Approvals

PharmaTech

The draft guidance provides information on the agencys accelerated approval process and criteria for approval.

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Eli Lilly to invest $3bn in Wisconsin facility expansion

Pharmaceutical Technology

Eli has announced a $3bn investment to expand its newly acquired manufacturing facility in Kenosha County, Wisconsin, in the US.

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Drug Digest: Focusing on Solid Dosage Trends and Demand

PharmaTech

In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development and manufacturing.

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FDA shares new draft guidance for accelerated approval

Pharmaceutical Technology

The new FDA guidance outlines how surrogate or intermediate clinical endpoints can support accelerated approval.

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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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ASH 2024: Bispecific Antibodies Face Key Challenges for Implementation in Community Cancer Centers

Pharmacy Times

Donald Moore discusses some of the obstacles that bispecific antibodies have faced in community cancer centers, including misconceptions coupled with a prevalent toxicity profile.

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Nature study finds obesity costs US industry $347bn a year

Pharmaceutical Technology

A study published in Nature estimates the economic burden associated with obesity on major US industries to be in excess of $347bn in 2023.

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USDA Announces Federal Order to Test Raw Milk Samples for H5N1 Bird Flu

Pharmacy Times

The US Department of Agricultures (USDA) guidance will help expedite H5N1 bird flu surveillance within the nations milk supply and dairy herds.

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Cell and gene therapy companies must demonstrate strong value proposition for investment          

Pharmaceutical Technology

Investment for companies developing cell and gene therapies (CGTs) was discussed during the GenScript Biotech Global Forum London 2024 conference held on 20 November 2024.

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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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Chemical spill response, step-by-step procedure for pharmaceutical operations

GMPSOP

Chemical spill response, step-by-step procedure for pharmaceutical operations Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Chemical spills threaten the health of personnel and the environment in pharmaceutical production facilities. When a spill occurs, you must respond quickly to mitigate these risks.

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Centenarians – unlocking the secrets of living to 100

Pharmaceutical Technology

Centenarians present a unique opportunity for researchers to explore longevity, they demonstrate impressive resilience to illness and injury.

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From Challenges to Solutions: Breaking Barriers to Revolutionize Patient Services

Pharmaceutical Commerce

A guide to overcoming the top obstacles facing patient services programs today.

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FDA ARMAT status for Affimed and Artiva’s lymphoma combo therapy

Pharmaceutical Technology

The US FDA has granted RMAT designation to Affimed and Artiva Biotherapeutics combination therapy for lymphoma.

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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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National Comprehensive Cancer Network Adds Jazz’s Ziihera as a Category 2A Treatment Option for Biliary Tract Cancers

PharmExec

Ziiheras addition as a category 2A treatment follows the FDAs accelerated approval of the drug for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.

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Muna-GSK alliance to fast-track Alzheimer’s disease treatments

Pharmaceutical Technology

Muna has entered a research alliance with GSK to expedite Alzheimer's disease treatments by discovering and validating new drug targets.

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Amgen, Lilly Unveil Major Expansion Projects

Pharmaceutical Commerce

The companies will be financially committing $1 and $3 billion into their respective manufacturing facilities.

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New study finds obesity costs US industry $347bn a year

Pharmaceutical Technology

A study published in Nature estimates the economic burden associated with obesity on major US industries to be in excess of $347bn in 2023.

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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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Navigating the Landscape of Global AI Governance

Pharmaceutical Commerce

The importance of embracing universal values and business models that prioritize humanity.

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Lilly and Amgen Each Announce Major Expansions of US Manufacturing Sites

PharmaTech

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

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The Launch of SPIMA Therapeutics

PharmExec

Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the companys launch and how multiple institutions have supported its pipeline.

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Peer Exchange: RFID Testing and Experimentation (Episode 3)

Pharmaceutical Commerce

In the third part of this roundtable discussion, experts discuss the value of Michigan State Universitys Axia Instituteincluding its RFID testing effortsand dive into the Institutes end-to-end RFID pilot that it has been conducting.

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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.