Mon.Apr 01, 2024

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H5N1 avian flu found in Texas individual who apparently was infected by dairy cows

STAT

Texas health officials reported Monday that an individual who had been in contact with cattle has contracted H5N1 avian flu, only the second case ever recorded in the U.S. The person had contact with dairy cattle that are believed to have been infected with the virus, the Texas Department of State Health Services said in a statement. It went on to say that the individual’s only symptom is eye inflammation — infection of the conjunctiva, the tissue surrounding the eye.

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With a rise in animal-human organ transplants, a drugmaker aims for a new standard of care

PharmaVoice

Eledon Therapeutics is developing a drug that could facilitate organ transplants from animals to humans as the procedure gains steam.

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Trending Sources

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New HHS guidance requires consent for pelvic, breast, and other sensitive examinations

STAT

Hospitals performing pelvic and other sensitive exams for training purposes without patients’ explicit consent, including on anesthetized patients, won’t be eligible for Medicare and Medicaid reimbursement, according to new guidance released on Monday by the Department of Health and Human Services’ Centers for Medicare and Medicaid Services.

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To advance women’s leadership, an effort ‘has to be purposeful,’ says EMD Serono exec

PharmaVoice

Gender diversity in leadership “doesn’t just happen,” — it requires institutional change, from investing in women’s startups to providing more generous family leave.

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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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Opinion: Banning teens from social media won’t help their mental health. Here’s what might

STAT

Since the U.S. surgeon general’s 2023 advisory on social media and teen mental health, public concern has skyrocketed around adolescents’ digital lives. Major news organizations and even state governments have pinned social media apps as addictive , dangerous, and the cause of the youth mental health crisis. In turn, calls to ban teens from social media apps have started to emerge, with mixed reception from policymakers nationwide.

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SAEM Clinical Images Series: Red Rash on My Legs

ALiEM - Pharm Pearls

A 23-year-old female with no known past medical history presented with a rash concentrated on her legs, with a few areas on her arms and chest. The rash began the day before presentation when she became overheated while wearing sweatpants in 104°F weather. The rash was mildly pruritic but not painful. She denied any prior reaction to her sweatpants that she has had for several months.

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More Trending

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5 FDA decisions to watch in the second quarter

BioPharma Dive

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

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STAT+: Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market

STAT

The Food and Drug Administration has cleared Otsuka Pharmaceutical’s digital treatment for major depressive disorder, offering a new option for millions of people who struggle with the stubborn mental health condition. Called Rejoyn , the smartphone-based treatment for major depressive disorder symptoms, developed with digital health company Click Therapeutics, is intended for use by prescription alongside antidepressants.

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Breaking barriers: Advances and challenges in therapeutic cancer vaccines

BioPharma Dive

The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.

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STAT+: Critics say U.K. decision on ALS drug could have ‘chilling effect’ on access to new genetic medicines

STAT

LONDON — Neurologists and patient advocates are up in arms over a policy decision by a U.K. health agency that they say will imperil access to an ALS treatment that’s available in the U.S. and on its way to approval in the European Union. The medicine in question, Biogen’s tofersen, is designed to treat a rare genetic form of the neurodegenerative disease, accounting for some 2% of all ALS cases.

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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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FDA clears first DTx for depression from Otsuka, Click

pharmaphorum

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

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STAT+: Scientists uncover potential path to treating deadly childhood tumor

STAT

Most targeted cancer drugs work like tranquilizer darts, snaring an overzealous gene that has spurred the cell into murderously rapid growth. But many tumors don’t have a hyperactive gene. Like the mayhem in “Cat in the Hat,” they are enabled by parental absence. They grow because the genes that are meant to provide discipline, guiding the activity of other genes or self-destructing a cell whose DNA is too damaged, are broken or missing.

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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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STAT+: Net prices for medicines fell considerably in 2023’s last quarter, mostly thanks to Humira biosimilars

STAT

The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis.

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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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One-time gene therapy could improve wet AMD

European Pharmaceutical Review

New clinical data has demonstrated the potential of a one-time gene therapy for vision loss. REGENXBIO’s Phase I/IIa trial investigated the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for wet age-related macular degeneration (wet AMD). The two-year data showed that ABBV-RGX-314 provided stable or improved visual acuity and retinal thickness in patients.

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STAT+: UnitedHealth’s surprising new target: Struggling Steward’s physician group

STAT

UnitedHealth Group has gobbled up physician practices at an astounding rate — roughly 20,000 last year alone. Most of them share a common trait: They’re independent groups, not affiliated with hospital chains. The Minnesota conglomerate’s plan to roll Stewardship Health, the physician arm of for-profit Steward Health Care, into its Optum subsidiary would mark a noteworthy departure from its usual fare.

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A step towards global harmonisation of GMP inspection protocols

Express Pharma

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ̵

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Why a bill meant to stop surprise medical bills hasn’t worked

STAT

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  Optum scooping up more docs during Change outage Just when you thought things couldn’t get weirder, UnitedHealth Group plans to buy Steward Health Care’s physician practice.

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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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Understanding CVS Health/McKesson and Why Pharmacies Lose Money on GLP-1s (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. Click here to see the original post from December 2023. Consider two apparently unrelated drug channel anomalies: In McKesson’s 2023 fiscal year, CVS bought $75 billion in pharmaceuticals from McKesson’s wholesale business—a jump of more than 35% compared with the previous year.

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Aardvark Therapeutics gearing up for $200 million IPO

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. Today, we learn about how scientists had a happenstance discovery about tumor-suppressor genes and used them to target aggressive pediatric tumor cells. We see a U.K. health agency make a controversial call about an ALS drug made by Biogen, and more.

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Leqembi maintenance dose filed in US, but SC form delayed

pharmaphorum

Eisai has filed to extend the label for its Alzheimer’s drug Leqembi to include a once-monthly maintenance regimen

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STAT+: Pharmalittle: We’re reading about AstraZeneca’s CEO pay, an ALS drug spat in the U.K., and more

STAT

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

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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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Mayo Clinic scientists pioneer immunotherapy technique for autoimmune diseases

World Pharma News

Mayo Clinic scientists have developed an immunotherapy strategy that potentially lays the groundwork for treating a spectrum of autoimmune diseases. The new technique, detailed in a preclinical study published in Nature Biomedical Engineering, involves combining chimeric antigen receptors (CAR) with mesenchymal stromal cells (MSC), resulting in engineered stem cells known as CAR-MSCs.

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US FDA grants fast track status to LISCure’s LB-P8 drug for PSC

Pharmaceutical Technology

FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.

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FDA clears AZ’s new PNH therapy Voydeya

pharmaphorum

AstraZeneca’s Voydeya has been approved by the FDA as an add-on to treatment with Soliris or Ultomiris for rare disease PNH

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How Dobbs v Jackson Women’s Health Organization Decision Influenced Self-Management Medication Use

Pharmaceutical Commerce

Cross-sectional study explores the impact of this monumental Supreme Court ruling.

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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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AstraZeneca gets FDA OK for rare disease drug acquired in Alexion buyout

BioPharma Dive

The clearance of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.

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Fail-First Policies Are Harming Patients

Pharmaceutical Commerce

Patients should not have to wait to access the medication they need.

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Vertex moves kidney disease drug into late-stage testing

BioPharma Dive

The drug, inaxaplin, is an important pipeline prospect for Vertex, which is working to expand beyond the cystic fibrosis medicines that made its name.

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Pharma Pulse 4/1/24: Uncertainties Associated with Accelerated Approval, Understanding DSCSA & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Jubilant Pharmova gets grant for radiopharmaceutical composition for diagnostic imaging with stable attributes

Pharmaceutical Technology

Discover the innovative patent by Jubilant Pharmova Ltd for a stable radiopharmaceutical composition of tetrofosmin, ensuring high purity and effectiveness in diagnostic imaging.

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