Mon.Nov 06, 2023

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A new study maps the lasting effects of gun violence on children and teens who survive their injuries

STAT

When Christian Pulcini was a pediatric emergency fellow at Children’s Hospital of Philadelphia, he witnessed firsthand the ways that gun violence affected children who survived it. He still remembers one young boy who had been shot in the neck while playing outside his home. Pulcini did not remove the bullet — a routine practice, often safer than removal.

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The thorniest questions facing pharma, according to a leading bioethicist

PharmaVoice

Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

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As extreme heat soars, laws to protect outdoor workers are bubbling up — and facing resistance

STAT

As weather starts to cool in much of the country, the heat-baked cement and sweaty afternoons from this summer fade from collective memory. But activists and labor groups representing outdoor workers haven’t forgotten. They are pushing lawmakers and regulators to keep facing the heat. On Tuesday, the Miami-Dade Board of County Commissioners will take a final vote on a proposed heat standard to protect outdoor workers.

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SAEM Clinical Images Series: Wolf in Sheep’s Clothing

ALiEM - Pharm Pearls

A 55-year-old female with a history of hyperlipidemia presents after a syncopal episode. She had mild nausea and diarrhea on the morning of presentation but otherwise had no prodromal symptoms before suddenly losing consciousness in a grocery store. Of note, she recalls a similar syncopal episode in the remote past, also preceded by gastrointestinal symptoms at that time.

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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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Opinion: There’s a real risk that harm reduction could be a fad

STAT

Harm reduction is having its moment in America. The doors of drug-related harm reduction have swung wide open after years of federal funding bans. Extensive opioid settlement payouts combined with an urgency to address the overdose crisis have allowed for harm reduction approaches to catch on like wildfire. But as renowned addiction author William White muses, “The fastest way to kill anything in America is to turn it into a superficial fad that dies from distortion and over-exposure.

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STAT+: Data backing prescription digital therapeutics found lacking in rigor, inclusivity

STAT

The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health care, but the companies behind these software-based tools face an uphill battle in convincing clinicians and insurers that their products can complement traditional medicine. That debate has largely focused on the quality of evidence backing these prescription digital therapies.

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First high-resolution 3D image offers insight into heart and muscle health

Pharma Times

The image helps researchers understand how heart muscles operate in disease - News - PharmaTimes

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STAT+: Astellas shows enough data for eye treatment to support expanded use, but still lags competitor

STAT

Astellas on Saturday presented study results showing an increased treatment effect over time for its approved medicine for a common type of vision loss. The new data are probably enough to convince the Food and Drug Administration to remove restrictions on the drug’s use, but they still don’t measure up to a competing treatment from Apellis Pharmaceuticals.

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The obesity drug effect: What medical device executives are saying

PharmaVoice

Investor concerns that interest in GLP-1s will slow demand for medical devices and procedures have shaved roughly $370 billion in value from stocks across the medtech sector, according to research by Mizuho.

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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+: Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines

STAT

Once again, Vertex Pharmaceuticals and a U.K. government agency are at odds over the value of life-saving cystic fibrosis medicines. In draft guidance published late last week, the National Institute for Health and Care Excellence stated that a groundbreaking treatment called Trikafta and two other cystic fibrosis medications sold by the company offer notable clinical benefits, but are not cost-effective.

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How over-investment is killing digital health companies

pharmaphorum

How over-investment is killing digital health companies Mike.

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STAT+: Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug

STAT

SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an experimental drug for treating plaque psoriasis though it proved safe and moderately effective in a mid-stage trial. Within hours, the company’s stock tanked by more than 80%. That’s because the company announced that the small molecule, VTX958, had not met the biotech’s internal goals to advance to the next phase of clinical development.

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PDA sounds alarm over AI use by pharmacy students

The Pharmacist

The Pharmacists’ Defence Association (PDA) has warned pharmacy students that the use of artificial intelligence (AI) technology risks charges of plagiarism and misconduct. In its October 2023 student newsletter, the PDA highlighted a ‘concerning rise’ in the number of students using AI programmes – such as ChatGPT and QuillBot – to write or enhance assessments. […] The post PDA sounds alarm over AI use by pharmacy students appeared first on The Pharmacist.

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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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STAT+: Government looks to tinker with new caps on Medicare Advantage broker payments

STAT

The federal government is proposing to rein in health insurance companies that entice brokers with lavish bonuses to sell their Medicare Advantage plans by placing a firmer cap on broker compensation. However, even with new guardrails in place, agents and brokers will still have strong financial incentives to move people into Medicare Advantage plans instead of pitching supplemental coverage for the traditional Medicare program.

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Anthropy23, part one: The future of AI, the future of Britain

pharmaphorum

Anthropy23, part one: The future of AI, the future of Britain Mike.

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STAT+: Moonlake’s credibility takes another hit with mid-stage study spin job

STAT

Moonlake Immunotherapeutics, a Swiss biotech, was buried Monday under an avalanche of its own data spin. It’s been awhile since I encountered a management team that speaks so arrogantly about the supposed supremacy of its own drug, but then fails to back up the talk with real data. Moonlake claimed its experimental antibody called sonelokimab delivered “landmark” results in a mid-stage study of psoriatic arthritis.

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Drug combos from AZ, Boehringer show promise in CKD

pharmaphorum

Drug combos from AZ, Boehringer show promise in CKD Phil.

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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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In experiment, electrical stimulation of the spinal cord helps a patient with Parkinson’s to walk

STAT

An experimental treatment that delivers an electrical current to the spinal cord appeared to notably improve the ability of a man with Parkinson’s to keep his balance and walk without freezing up, a development that experts say could be a dramatic advance if it is found to deliver similar benefits in larger studies. The volunteer, identified as Marc, a 62-year-old who has had Parkinson’s for 30 years, spoke on a call with reporters last week.

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UK patient data project reaches one million volunteers

pharmaphorum

UK patient data project reaches one million volunteers Phil.

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STAT+: Pharmalittle: Pharma trade group slams European Commission proposal; U.S. lawmakers demand FDA explain its approach to shortages

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was somehow relaxing and invigorating, because that oh-so familiar routine of online calls, meetings, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to nudge it in a better direction with a cup or three of stimulation.

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Bayer doubles down on Factor XIa with new phase 3 trial

pharmaphorum

Bayer doubles down on Factor XIa with new phase 3 trial Phil.

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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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XBI biotech index rises, giving investors a shred of hope

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Happy Monday. So, we’ve got a welcome bump in the XBI, see that European regulatory conditions are prompting Ozempic maker Novo Nordisk to look stateside for growth, and more.

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Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents

Drug Patent Watch

A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the… The post Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents appeared first on DrugPatentWatch - Make Better Decisions.

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RPS supports government proposals to regulate cosmetic procedures

The Pharmacist

The Royal Pharmaceutical Society (RPS) has backed government plans to impose regulations on high-risk non-surgical cosmetic procedures to ensure they can only be undertaken by qualified and regulated healthcare professionals. Responding to a government consultation on how to make non-surgical cosmetic procedures – such as botox and fillers – safer for the public in England, […] The post RPS supports government proposals to regulate cosmetic procedures appeared first on The Pharmacist.

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Drug Diversion in Healthcare is a National Problem, but Recent Survey Shows a Promising Path Forward

PharmExec

Healthcare organizations can lower their risk of drug diversion by strengthening staffing, employee training, and technology.

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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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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law Blog: Biosimilars

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Glenmark gets USFDA nod for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg

Express Pharma

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon. Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the US by Glenmark Pharmaceuticals US.

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Pharmacy Security - How to Safeguard Your Patients and Inventory

PioneerRx

It pays to be safe. Pharmacy security is an understated but essential aspect of pharmacy ownership. Whether you’re stocking medications, testing supplies.

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