Tue.Nov 19, 2024

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Opinion: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Proposal for temporary pharmacy in shipping container to address access issues

The Pharmacist

A temporary pharmacy could be set up in a shipping container in Warminster to address an ‘immediate need’ for services in the area while a permanent facility is developed. The proposal comes after local councillors earlier this year called for urgent action to address a pharmacy ‘crisis’ in the area. A planning application for a […] The post Proposal for temporary pharmacy in shipping container to address access issues appeared first on The Pharmacist.

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STAT+: Pharma still ‘falling short’ in providing access to low- and middle-income countries, analysis finds

STAT

Although more pharmaceutical companies are tailoring their business models to focus on low-income countries, a new analysis finds that overall industry efforts remain limited and patient access continues to suffer as a result. Notably, momentum has stalled in reaching licensing deals that are designed to make lower-cost generic drugs available in parts of the world where brand-name medicines are unaffordable, and few companies have pursued technology transfer agreements.

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Finding hope and purpose as a millennial pharmacist

The Pharmacist

Nathan Burley argues that younger pharmacists have a distinct perspective on the challenges they face in pharmacy – that all require a strong sense of optimism to navigate. As a millennial healthcare professional, I often find myself caught between two conflicting worlds. On one hand, there’s the relentless pressure of healthcare — burnout, staff shortages […] The post Finding hope and purpose as a millennial pharmacist 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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STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

STAT

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI.  This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet

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Emcure Pharmaceuticals launches campaign addressing male anaemia

Express Pharma

Emcure Pharmaceuticals has launched a nationwide public awareness campaign to address the increasing prevalence of anaemia among Indian men. The campaign, featuring former Indian cricket captain MS Dhoni, was unveiled through a video released on International Men’s Day. It aims to educate the public on the health implications of anaemia in men and encourage early diagnosis and treatment.

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'The great prescribing debate': What should clinical supervision look like?

The Pharmacist

Three models of clinical supervision were explored at the Royal Pharmaceutical Society (RPS) conference earlier this month, in a session chaired by Susan Roberts, the associate director for pharmacy at NHS Education for Scotland. The session was badged as 'The great prescribing debate' and heard about approaches being used to support pharmacists to develop into […] The post 'The great prescribing debate': What should clinical supervision look like?

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STAT+: Merck says study of under-the-skin version of Keytruda, a bid to extend the drug’s sales, succeeded

STAT

Merck said a new formulation of the best-selling drug, Keytruda, appears to deliver similar blood levels of the medicine when it is given as a shot as when it is given intravenously. For Merck, the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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The Future of Partnerships in Generic Drug Development

Drug Patent Watch

The pharmaceutical industry is undergoing significant transformations, particularly in the realm of generic drug development. Recent trends and advancements in technology, research, and collaboration are reshaping the landscape of generic drug development, leading to new opportunities and challenges for pharmaceutical companies.

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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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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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Large Chains’ Position in 2025’s Part D Pharmacy Networks: Supermarkets Take the Lead in a Shrinking PDP Market

Drug Channels

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). Today, we examine the seven largest retail chains’ participation in the 12 major 2025 Part D networks that the five largest plan sponsors will offer. As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025.

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New PAGB research highlights importance of self-care for easy-to-treat conditions

Pharma Times

The census found that 56% of people visit their GP for a UTI and 27% for thrush

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FDA says no to Astellas' geographic atrophy drug

pharmaphorum

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US. The company has received a complete response letter (CRL) from the FDA for a proposed update to the labelling for Izervay (avacincaptad pegol) that sought to include the results of the phase 3 GATHER2 trial and improve the drug's competitive profile against rival Syfovre (pegcetacoplan) from Apellis.

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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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Novartis and Ratio to progress next-gen radiotherapeutic

European Pharmaceutical Review

Novartis Pharma AG has agreed to a radiotherapeutic radioligand therapy-focused license and collaboration with Ratio Therapeutics. Through this deal, Ratio is eligible to receive milestone payments up to $745 million. The collaboration will utilise Ratio’s expertise in radioligand therapy and its technology platforms for development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.

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AstraZeneca invests $3.5 billion in R&D and manufacturing in the United States

World Pharma News

AstraZeneca has announced $3.5 billion of capital investment in the United States focused on expanding the Company's research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy.

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Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List

Pharmafile

18 November 2024 – Manchester, UK – Chiesi Group, an international biopharmaceutical company focused on research, has been named one of the 25 World’s Best Workplaces™ in 2024 by Great Place To Work® (GPTW) and Fortune magazine, ranking 23rd on this year’s list.The news marks the first time any European pharmaceutical company has achieved the […] The post Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List appeared first on Pharmafile.

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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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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C Ray Therapeutics raises $100 million to develop radiopharmaceuticals

Outsourcing Pharma

The financing round will fund the improvement of the companyâs technology platform for the discovery and development of innovative radionuclide drug conjugates.

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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

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Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease

Outsourcing Pharma

Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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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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Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease

Outsourcing Pharma

Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.

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Under-the-skin Keytruda comparable to infused version in Phase 3 study, Merck says

BioPharma Dive

Merck plans to discuss the data with regulators as it lags rivals Roche and Bristol Myers in bringing forward a subcutaneous form of its cancer drug.

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C Ray Therapeutics raises $100 million to develop radiopharmaceuticals

Outsourcing Pharma

The financing round will fund the improvement of the company’s technology platform for the discovery and development of innovative radionuclide drug conjugates.

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Incyte shares sink on setback for drugs acquired in $750M buyout

BioPharma Dive

The company paused testing of one candidate acquired in its April deal for Escient and scrapped another in a blow to its diversification plans.

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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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AHA 2024: CV effectiveness of GLP-1RA + Empagliflozin therapy in adults with T2D

Pharmaceutical Technology

SGLT-2I therapies reduce the risk of heart failure and this study clearly demonstrates the benefit of adding them onto GLP-1RA therapy.

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Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

BioPharma Dive

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

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Researchers Assess Incidence of Shingles Vaccination Among Individuals with Asthma

Pharmacy Times

An increase of shingles vaccination was reported among individuals with asthma.

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Top 7 Hardest Addiction Medicine Board Review Questions

Board Vitals - Pharmacist

With a pass rate of 82% in 2023, the Addiction MedicineBoard Certification Exam is no easy feat.If your exam is right around the corner,we suggest preparing with practice questions. To help you get started,see if you cancorrectlyanswerthetopfivemost difficultAddiction Medicine Board Review Questionsfrom the BoardVitals Addiction Medicine Question Bank.AmongBoardVitalsusers, these questions were thetop seven that wereanswered incorrectly the most times out of 700+board review questionslast year.D

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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.