Mon.Jun 10, 2024

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Millions fewer people may need statins, a new study suggests. But guidelines have yet to agree

STAT

It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time. That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribin

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From Collision to Clarity: PECARN cervical spine injury prediction rule for injured children

ALiEM - Pharm Pearls

For years, adult literature has provided clear guidelines for cervical spine imaging through the NEXUS and Canadian C-spine Rule (CCR) tools. These have been invaluable in helping clinicians decide when to image the neck in trauma patients. Similarly, the Pediatric Emergency Care Applied Research Network (PECARN) has developed robust tools for assessing blunt head trauma in children.

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Lab experiment shows exactly how heat waves can put hearts into ‘oxygen debt’

STAT

When temperatures soar, so do heart attacks. Now, a lab experiment explains just how temperatures climbing into Fahrenheit’s three-digits can cause ischemia and potential heart attacks, all while international efforts to limit long-term warming seem like they’re running out of time. The experiment, which gradually exposed participants to higher temperatures, showed that exposure to heat even while resting made participants’ hearts work harder, ramping up blood flow through t

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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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+: Moderna says data show its combination Covid-flu vaccine generates a strong immune response

STAT

Moderna announced Monday that, in a Phase 3 clinical trial, its combination Covid-19 and influenza vaccine generated stronger immune responses in older adults than individual vaccines that target those viruses. The findings, disclosed in a press release, suggest the company may be on track to bring a combination flu and Covid vaccine to the market, potentially as early as autumn 2025.

Immunity 360

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STAT+: FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment

STAT

Advisers to the Food and Drug Administration voted 11-0 on Monday to recommend the approval of a drug for early Alzheimer’s disease made by Eli Lilly — ruling that the treatment’s ability to slow the cognitive decline in patients outweighed its safety risks. The unanimous outcome of the daylong advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognit

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Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

Pharma Times

Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK

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Opinion: Curing rare childhood diseases will falter unless Congress steps up

STAT

When our son Peter was diagnosed with an ultra-rare form of muscular dystrophy at the age of 10, the first question we asked was: Is there a treatment? The answer was no. By the time our daughter Maggie, then just 6, received the same diagnosis, that answer hadn’t changed. We soon learned that our situation is tragically common. As many as 30 million Americans live with some type of rare disease, defined as a disease that affects fewer than 200,000 people.

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What can pharma companies do to quicken the pace of digital disruption?

pharmaphorum

Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.

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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+: Medical device trials still don’t enroll enough women, study finds

STAT

Women have always been underrepresented in medical research. A new study reveals that not much has changed, especially when it comes to tests of cardiovascular devices.  In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020.

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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STAT+: Humana scores a win in a Medicare Advantage case

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. Always watch the courts There’s a joke that all reporters essentially are legal reporters. But it’s kind of true, especially within the health care beat. Congress can’t get anything done, and the federal agencies have their routine rule-making powers.

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NPA: Protest action must put safety first

The Pharmacist

Any action that pharmacies take to raise awareness of the financial crisis facing the sector should put patient and staff safety first, the National Pharmacy Association (NPA) has said. This comes as the Pharmacists’ Defence Association (PDA) called for any action within the sector to safeguard patient safety and protect the autonomy of responsible pharmacists, […] The post NPA: Protest action must put safety first 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+: Watch: How Harvard researchers boosted an ALS patient’s independence with a box and a balloon

STAT

John Goodson practiced medicine for almost 50 years at Massachusetts General Hospital in Boston. As a primary care physician, he saw thousands of patients and ailments, so when he struggled to raise the front of his foot in 2021, he felt a knowing dread. “As a physician, I had made the diagnosis of a patient with ALS and developed a close relationship and followed this patient right through to his death at home,” said Goodson.

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Moderna says combination flu, COVID shot succeeds in study

BioPharma Dive

Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

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Opinion: How faith leaders like me can help address America’s obesity epidemic

STAT

Many factors drive America’s obesity epidemic — environment, genetics, eating habits, and more. Solving the problem isn’t solely about getting people to lose weight. What’s also needed is overcoming the stigma and systemic bias directed at people living with obesity. Most people are dealing with a world of emotional stress.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog: Biosimilars

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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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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The biotech news you missed from the weekend

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Lots on vaccines this morning: Moderna says its combination shot for Covid and flu works well, and might help improve uptake in the broader population. And the FDA just cleared GSK’s RSV vaccine for younger at-risk adults.

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Crucial Insights on Patent Litigation Strategies in Pharma Industry

Drug Patent Watch

In the “Patent Effect” podcast, Mustafa introduces his guest, Hakan Yum, the IP Director of Exrain Pharma, based in Sweden.

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STAT+: Teladoc names insurance, finance exec as its new CEO

STAT

Virtual care company Teladoc has a new chief executive officer following the abrupt departure of its long-time leader in April. Chuck Divita, who took on the role Monday, previously led the commercial markets business at GuideWell, the parent company of health plan Florida Blue. He was also previously chief financial officer at FPIC Insurance group, a publicly traded insurance company focused on medical liability.

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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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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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STAT+: Pharmalittle: We’re reading about a Moderna Covid-flu vaccine, a paused Pfizer study, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

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ABHA’s Scan and Share service facilitates 3 crore OPD registrations nationwide

Express Pharma

The service enables patients to conveniently register for OPD appointments by scanning a QR code displayed at the OPD registration counter The National Health Authority (NHA), in its mission towards digitising healthcare services has generated over three crore tokens for Out-Patient Department (OPD) registrations through the ABHA-based Scan and Share service.

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Drug Shortage Reports Emphasize Continuing Problems

PharmaTech

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

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Roche’s Vabysmo showcases stronghold across wAMD and DME spaces : GlobalData

Express Pharma

Roche recently presented post-hoc analysis results of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials of Vabysmo (faricimab), a VEGF and Ang2 inhibitor, at the Association for Research in Vision and Ophthalmology (ARVO) conference. The data showcases Vabysmo’s efficacy in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), as well as the Swiss pharma major’s eagerness to establish the prescription injection as a leading therapy for multiple ophthalmology indic

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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 OKs wider use of Almirall’s actinic keratosis drug

pharmaphorum

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri. First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can be a precursor to skin cancer.

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Pharma Pulse 6/10/24: Sustainability in Clinical Trials, Merck Bets on AI Drug-Design Partnerships & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Lilly Alzheimer’s drug gets unanimous backing of FDA panel

BioPharma Dive

The expert committee concluded donanemab’s benefits outweigh its risks, despite some concern over the drug’s safety.

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