Tue.Oct 22, 2024

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STAT+: Novo asks FDA to bar compounders from making Ozempic copies

STAT

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years.

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2024 PharmaVoice 100s: Patient Champions

PharmaVoice

Leaders advancing health advocacy, DEI initiatives and better medicine access for patients.

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Trending Sources

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STAT+: Senators demand answers on telehealth platforms from Pfizer and Eli Lilly

STAT

Senators led by Sen. Dick Durbin (D-Ill.) on Monday demanded answers from Pfizer and Eli Lilly about their relationship with the telehealth prescribers they point patients to from their websites, seeking to determine whether the pharma giants are violating the federal anti-kickback statute. This year, both Pfizer and Eli Lilly launched websites that allow users to learn about their medications, follow links to “talk to a doctor now,” and fill their prescriptions through an online p

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With activist investment rising, Pfizer’s battle with Starboard reflects the industry’s post-pandemic tumble

PharmaVoice

Pfizer’s proxy battle with Starboard has gotten messy. It’s the latest in a series of activist investor campaigns that have been on the rise in recent years.

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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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Dietary guidelines panel stresses fruits and vegetables but stops shy of major changes 

STAT

There’s a fundamental barrier to scientific certainty in food science. People eat foods, not nutrients. The experts charged with advising federal health officials on the 2025-2030 Dietary Guidelines for Americans had to scale a mountain of research challenges like this basic impediment, starting with the impossibility of randomly assigning people to eat only x or y for 30 to 40 years.

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In a bid to treat their children’s rare diseases, these three parents founded companies

STAT

Ten years ago, neither Allyson Berent, Terry Pirovolakis nor Michelle Werner expected to be founders of biotech companies. But they’ve all done so with the goal of helping to treat their children’s rare diseases.  The three parents took the stage at the 2024 STAT Summit to talk about the challenges of trying to find treatments for rare diseases — from securing funding to translating research in animals to humans to commercial barriers.

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Valneva Scotland announces year-long support for local cancer charity Team Jak

Pharma Times

The company’s workforce will volunteer and fundraise for Team Jak throughout the year

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STAT+: Editas tacks again, steering from lead sickle cell treatment to new one

STAT

Editas Medicine said Tuesday it will license out or partner its lead sickle cell treatment, the latest shift for a tarantella company that has repeatedly switched direction and leadership since first emerging as one of the first CRISPR biotechs a decade ago.    Editas will now focus on a different, newly announced sickle cell program.

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Sanctions for 'inadvertent dispensing' of puberty blockers will be 'proportionate and case-by-case'

The Pharmacist

EXCLUSIVE Any enforcement of sanctions against pharmacists for 'inadvertent dispensing' of puberty blockers outside the terms of legislation 'will be considered on a proportionate and case-by-case basis', the government has promised. This comes after the Royal Pharmaceutical Society (RPS) highlighted that pharmacists are the 'only' profession at risk of criminalisation in the government's changes to […] The post Sanctions for 'inadvertent dispensing' of puberty blockers will be &

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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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STAT+: Michelle Tarver to lead FDA medical device center

STAT

Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an email reviewed by STAT and sent out to FDA device staff on Tuesday afternoon. Tarver has temporarily served in the role since veteran devices head Jeffrey Shuren announced his departure in July. The agency conducted a nationwide search for Shuren’s replacement, but Tarver quickly seemed to be the top pick, shadowing Shuren at conferences and town halls.

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No link with metformin in dads and birth defects, finds review

The Pharmacist

Men taking metformin can be reassured that there is no link with birth defects, say researchers who reviewed data from more than three million pregnancies. The study was done after Danish researchers reported a possible association in 2022 but for which there was ‘no plausible biological mechanism’. Now a careful analysis of national birth registries […] The post No link with metformin in dads and birth defects, finds review appeared first on The Pharmacist.

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HLTH 2024 buzz: GLP-1s, AI copilots, and a mysterious robot

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Will ‘responsible AI’ spawn a new market for tech? This year’s gathering features HLTH ‘s signature opulence and spectacle: as usual, a hair salon for attendees, an indoor puppy park, and a vast exhibit floor crammed with flashy booths, giveaways a

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Editas, changing course again, looks to partner lead CRISPR therapy

BioPharma Dive

The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.

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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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How a tragic diagnosis sent a journalist on a scientific odyssey

STAT

Genetics can be cruel. Lawrence Ingrassia, a longtime journalist, has learned that the hard way. A genetic mutation that runs in his family predisposes those who carry it to developing malignant tumors of all types. It’s why, at age 69 and 30 days, he became the longest living member of his family.

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Seven pillars of GenAI for enterprise-level value generation

pharmaphorum

Discover the seven essential pillars of GenAI for generating value at an enterprise level and leveraging artificial intelligence to drive innovation and growth.

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‘Switchable’ CAR-T startup raises $112 million

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.  Good morning. Check out the latest promo we’re running, where you can get your first three months of a STAT+ subscription for $20.

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Vizient reports strides in 2023 DEI progress

vizient

The report includes insights across key performance indicators and features programs and solutions Vizient implements to ensure a diverse, equitable and inclusive work environment.

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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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Morning Rounds: Free OTC birth control, cholera deaths, clinicians and gender identity

STAT

Good morning! There are two impending deadlines weighing on my mind this week: We’ve got exactly two weeks until the presidential election, and 12 days until daylight savings time ends here in Boston. Philly hospitals stop using race-adjusted algorithms A coalition of 12 Philadelphia-area health systems announced yesterday that its members have abandoned the use of race adjustments in four clinical tools commonly used to guide care, a move that health leaders say will improve treatment an

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France warns of penalties if Opella production goes offshore

pharmaphorum

Sanofi is now in exclusive talks with private equity company Clayton Dubilier & Rice over the sale of a controlling stake in its consumer health business Opella, as the French government seeks guarantees it will keep production and jobs in France.

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D.C. Diagnosis: Bolstering addiction treatment polls well across parties, new survey shows

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Hello and happy Thursday! In a tense election season, my go-to feel-good show has been The Great British Baking Show. Feelings about Caramel Week and news tips are always welcome to rachel.cohrs@statnews.com.

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Europe's share of clinical trials falling, with China rising

pharmaphorum

The proportion of commercially sponsored clinical trials run in Europe almost halved over the last 10 years and is now trailing China

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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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JB Pharma announces ESG commitments with launch of third sustainability report

Express Pharma

J.B. Chemicals & Pharmaceuticals (JB Pharma) has announced its Environmental, Social, and Governance (ESG) commitments with the release of its third Sustainability Report. The report highlights the company’s achievements in reducing its environmental impact and improving resource efficiency, marking a significant milestone in its dedication to sustainable growth.

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Starboard spells out its concerns with Pfizer's direction

pharmaphorum

Starboard Value CEO Jeff Smith pulls no punches in his assessment of Pfizer failings, which he claims have resulted in at least $20bn in lost value

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CHMP Gives Positive Opinion to Novo Nordisk Hemophilia Treatment

PharmaTech

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

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MangoRx hits back at Eli Lilly’s weight loss drug copycat claims

Pharmaceutical Technology

Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.

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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.