Wed.Sep 11, 2024

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How a government scientist is pushing to supersize research into ultra-processed foods

STAT

CHICAGO — The last place you might have expected Kevin Hall to make a plea for help was at a conference of scientists who work for global food conglomerates. After all, the government researcher is the leading scientific voice in the United States warning that a steady diet of these engineered products might be a crucial driver of the nation’s epidemic of overeating.

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Why pharma should redefine ‘women’s health’

PharmaVoice

A broader approach recognizes the challenges disproportionately impacting women and could lead to better outcomes, according to Organon.

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Opinion: Why so many patients are confused about CPR and do-not-resuscitate orders

STAT

When a patient is admitted to the hospital in the U.S., there’s a standard question physicians like me are supposed to ask: “If your heart stops beating, do you want us to do CPR?” On the surface, this may seem like a mechanic asking a customer, “If your car stalls, do you want us to jumpstart the engine?” Who would say no to this, especially in a hospital?

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3 FDA approval dates to watch in the year’s final push

PharmaVoice

A handful of potential blockbusters are marching toward FDA review.

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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+: FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’

STAT

WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who should be involved in health care AI governance, the U.S. Food and Drug Administration commissioner said that health systems need to take a leading role. “I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on liability when these algorithms go wrong,” said Robert Cal

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The benefits of ePI for patients and the planet

pharmaphorum

Discover the advantages of paperless medicine information for patients and the environment. Learn how electronic product information benefits both your health and the planet.

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More Trending

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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STAT+: FDA scolds AbbVie over ‘misleading’ TV ad for a migraine pill featuring Serena Williams

STAT

The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims about a  TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing. The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache th

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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

FDA Law Blog: Biosimilars

By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),

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STAT+: ‘Sarepta’s like a curse on me’: FDA commissioner dismisses controversy over Elevidys

STAT

WELLESLEY, Mass. — At an event with journalists Tuesday outside of Boston, U.S. Food and Drug Administration commissioner Robert Califf dismissed criticism that the agency is lowering standards for new drug approvals, even when clinical trials fail. This summer, the FDA expanded Sarepta Therapeutics’ accelerated approval for the Duchenne muscular dystrophy gene therapy Elevidys , despite the drug failing its Phase 3 trial.

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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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Innovative medicine production site inaugurated in France

European Pharmaceutical Review

Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme

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Blood cell counts have unfairly kept Black and Middle Eastern people from clinical trials, study says

STAT

One of the most important measurements for cancer patients is the neutrophil count. Certain cancer therapies like chemotherapy can be harsh on these white blood cells, so cancer patients need their neutrophil count to be in a given range when undergoing those treatments or before enrolling in particular clinical trials. That can be a problem for people who have a natural blood variation called the Duffy-null phenotype.

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A path to Viksit and Swasth Bharat through nutraceuticals

Express Pharma

Optimal health and wellness for each citizen has been among the top objectives of successful countries. It is the backbone of economic and social growth. India too has realised the importance of a healthy nation. As we chase the goal of becoming Viksit Bharat by 2047, authorities have prioritised the concept of Swasth Bharat. But before we reach the summit, we must overcome some tall mountains.

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Opinion: The surgeon general’s warning on parental mental health doesn’t go far enough

STAT

Surgeon General Vivek Murthy’s latest warning unearths concerning statistics about the mental health and well-being of American parents. These findings resonated with me deeply on two levels. First, I am a parent of three school-age children. Second, I am a trained therapist and head of behavioral health at a provider organization focused on caring for the most vulnerable members of our population — Medicaid members and those dually eligible for both Medicaid and Medicare.

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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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Prodrugs and patents: Enhancing therapy adherence and reducing side effects 

Pharmaceutical Technology

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

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Eli Lilly releases new data on weekly insulin

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Amycretin has some intriguing results in obesity Amycretin, an experimental Novo Nordisk obesity pill that targets both amylin and GLP-1 receptors, spurred significant weight loss in a Phase 1 study, the company announced yesterday.

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Strides Pharma secures shareholder and creditor approval for OneSource Pharma CDMO Initiative

Express Pharma

Strides Pharma Science (Strides) has announced that its equity shareholders and secured creditors have overwhelmingly approved the company’s strategic initiative to create OneSource Specialty Pharma Limited, India’s first specialty pharma Contract Development and Manufacturing Organization (CDMO). The approval was also extended to OneSource and SteriScience Specialties Private Limited in meetings convened under the guidance of the Hon’ble National Company Law Tribunal (NCLT).

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STAT+: Q&A: For this South Dakota health system, leaning into telehealth means learning ‘webside’ manner

STAT

Fighting a massive snowstorm to get to the doctor in the Dakotas is an unpleasant business. So is driving hours to see one of the two or three obstetricians in northern Minnesota. But Dave Newman, chief medical officer of virtual care at Sanford Health, is counting on technology to change that. Last year, a STAT documentary highlighted how Sanford, a large rural health system serving North Dakota, South Dakota, and Minnesota, is using telehealth to reach more patients than ever before.

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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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UK doctors sceptical of AI's role in treatment

pharmaphorum

One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds

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STAT+: Pharmalittle: We’re reading about a Novo weight loss study, a GSK vaccine failure, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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Darzi report: access to pharmacies 'a great strength' but 'at risk'

The Pharmacist

An independent investigation into the NHS has praised the value of community pharmacies and preventative services, while highlighting that more investment is needed in primary care to improve the health and care of the nation as a whole. The Darzi review was commissioned by the health and social care secretary Wes Streeting to deliver 'a […] The post Darzi report: access to pharmacies 'a great strength' but 'at risk' appeared first on The Pharmacist.

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Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety

Drug Patent Watch

The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of nanotechnology. This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients.

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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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FDA issues warning letters to two Chinese firms over data integrity concerns

Express Pharma

The U.S. Food and Drug Administration (FDA) has issued warning letters to two Chinese nonclinical testing laboratories, citing concerns about laboratory oversight and animal care violations. The labs, Mid-Link Testing Company in Tianjin and the Sanitation & Environmental Technology Institute of Soochow University in Suzhou, provide third-party testing and validation data services for device manufacturers’ premarket submissions to the FDA.

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Concerns prescribing service will not be ready by 2026

The Pharmacist

Slow progress on the community pharmacy prescribing pathfinder project has sparked concerns that a viable commissioned community pharmacy prescribing service will not be ready by 2026, The Pharmacist has learned. Company Chemists' Association (CCA) chief executive Malcolm Harrison told The Pharmacist that while the new digital prescribing solution was ‘good news’, the CCA was still […] The post Concerns prescribing service will not be ready by 2026 appeared first on The Pharmacist.

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Scotland first in UK to approve new myeloma treatment

Pharma Times

Patients with relapsed multiple myeloma gain access to life-extending therapy

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Tower Cold Chain, CRYOPDP Collaborate on Growing Temperature-Controlled Offerings

Pharmaceutical Commerce

The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.

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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.

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AI-Powered chest X-Rays detect lung cancer early

Pharma Times

New evidence highlights AI’s potential in early lung cancer detection

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Pfizer highlights diverse oncology oortfolio and combination approaches at ESMO 2024

World Pharma News

Pfizer Inc. (NYSE: PFE) continues to showcase potential practice-changing research and next-generation candidates across its robust Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17 in Barcelona. Data from more than 50 company-sponsored, investigator-sponsored and collaborative research abstracts, including more than 10 oral and mini-oral presentations, will be presented across the company's tumor areas and core scientific modalities

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Pharmacy forced to rely on donated PPE from dentist patients, Covid inquiry told

The Pharmacist

A community pharmacy was forced to rely on donated personal protective equipment (PPE) from patients who were dentists during the pandemic, the UK Covid-19 Inquiry has heard. Lee John-Charles, a lawyer and a representative for the National Pharmacy Association (NPA), told the inquiry this week how 'many' pharmacies were required to source their own PPE […] The post Pharmacy forced to rely on donated PPE from dentist patients, Covid inquiry told appeared first on The Pharmacist.

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PDA/FDA Joint Regulatory Conference: Product Quality Risk in Aging Facilities

PharmaTech

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

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Advice on dispensing valproate to men shared by GPhC

The Pharmacist

The General Pharmaceutical Council (GPhC) has clarified what pharmacists need to do following a Medicines and Healthcare products Regulatory Agency (MHRA) warning to men taking valproate. Last week, the UK medicines regulator said men taking valproate and their partners should use effective contraception, because of a small increased risk of harm to children if the drug […] The post Advice on dispensing valproate to men shared by GPhC appeared first on The Pharmacist.

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