Mon.Jul 29, 2024

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STAT+: In a big step for liquid biopsy, FDA approves a blood test for colorectal cancer

STAT

The Food and Drug Administration on Monday approved a blood test intended to detect colon cancer, a product many experts hope will help catch cases of the disease early enough so that they can be more easily treated. The test, called Shield and made by Guardant Health, a Palo Alto, Calif.-based biotech firm, comes with a drawback: It is not as good as a colonoscopy and other tests at detecting precancerous or early stage cancers.

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Neuro drugs are still faltering, despite rising investment

PharmaVoice

A brain-on-a-chip developer says better preclinical modeling could help move the needle.

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Bird flu snapshot: Upstart manufacturers in low- and middle-income countries to start early vaccine work

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on the H5N1 flu outbreak in dairy cows that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. A network of nascent vaccine manufacturers in low- and middle-income countries will soon start preliminary work to develop messenger RNA vaccines targeting the H5N1 bird flu virus, an effort that could speed production during a pandemic, should

Vaccines 363
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Study finds 3D-printed blood vessels could improve heart bypass outcomes

Pharma Times

Coronary heart disease is the most common form of heart and circulatory disease

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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+: Sarepta demanded Duchenne patient advocacy group censor video critical of the company

STAT

Sarepta Therapeutics demanded a prominent patient advocacy organization censor a video that contained pointed criticism of the company’s recently approved gene therapy for Duchenne muscular dystrophy, STAT has learned. The incident raises questions about the financial ties between Sarepta and the advocacy group, Parent Project Muscular Dystrophy, and whether the drugmaker uses its money to influence, or even muzzle, debate over its Duchenne medicines.

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Blood tests for Alzheimer’s diagnosis were 91% accurate in new study

STAT

New blood tests could help doctors diagnose  Alzheimer’s  disease faster and more accurately, researchers reported Sunday – but some appear to work far better than others. It’s tricky to tell if memory problems are caused by Alzheimer’s. That requires confirming one of the  disease’s hallmark signs  — buildup of a sticky protein called beta-amyloid — with a hard-to-get brain scan or uncomfortable spinal tap.

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MIT study reveals how specific cells in AD become vulnerable and resilient

Pharma Times

The neurodegenerative condition is recognised as the most common form of dementia

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Could cow vaccines help halt the spread of bird flu in U.S. herds? Experts are divided

STAT

With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows. Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing app

Vaccines 362
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Leading GP notes 'safe and appropriate' Pharmacy First

The Pharmacist

Pharmacists are dealing with patient need in 'a safe and appropriate way' under Pharmacy First, a leading GP has said. Speaking about Pharmacy First at the NHS England (NHSE) board meeting last week, non-executive director Professor Dame Helen Stokes-Lampard said: 'We have so much unmet need in general practice is that what's happened is that […] The post Leading GP notes 'safe and appropriate' Pharmacy First appeared first on The Pharmacist.

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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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New cardiovascular risk model could greatly decrease use of statins and increase heart attacks, study warns

STAT

If up to half of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates. The research paper, published Monday in JAMA , is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.

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'MHRA set to streamline UK medical device approvals'

The Pharmacist

An MHRA statement of policy intent is designed to recognise approvals from specific foreign territories and to simplify and speed-up the regulatory process for medical devices. Thorrun Govind, solicitor (Brabners LLP), pharmacist and TV health expert, explains what this means. Framework for medical device approvals Under the new MHRA proposed framework for international recognition of […] The post 'MHRA set to streamline UK medical device approvals' appeared first on The Pharmaci

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STAT+: Disruptions loom for telehealth providers and patients as Congress inches closer to deadline

STAT

Around November, Kivo Health, a telehealth provider of pulmonary rehabilitation services, will need to start warning older patients that their sessions may not be covered by Medicare in the new year. Kivo was founded in 2022, and it’s covered by Medicare thanks to telehealth flexibilities passed by Congress during the Covid-19 pandemic. Those flexibilities expanded what kinds of care people on Medicare can receive over telehealth — but they are set to expire at the end of 2024.

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UK partnership aims to support NHS use of depression app

pharmaphorum

Otsuka has teamed up with one of the innovation arms of the NHS to explore how a digital therapeutic (DTx) for major depressive disorder (MDD) could be deployed within the health service.The alliance with Health Innovation Oxford & Thames Valley (Oxford HIN) is focusing on Care for MDD, an app-based DTx that has been co-developed by Otsuka and digital health specialist Click Therapeutics.

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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+: Parasite engineered to treat brain development disorder in mice shows potential in study

STAT

The human body works hard to prevent outside substances from entering the brain — which makes it a challenge to get drugs into the brain to treat neurological diseases. A study published today in Nature Microbiology opens the door to a potential clever solution, showing how Toxoplasma gondii, a parasite that is able to cross the blood-brain barrier, can be engineered to treat a brain development disorder in mice.

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GSK joins Flagship's flotilla of pharma partners

pharmaphorum

Flagship Pioneering signs another strategic-level deal with a big pharma group, with GSK agreeing an alliance potentially worth more than $7 billion

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Opinion: Mark Cuban’s company won’t fix drug costs, but it can still help rectify America’s drug shortages

STAT

Americans are facing at least two prescription drug crises simultaneously. One is the outrageously high cost of drugs, which runs to more than $500 billion per year. The other relates to extreme drug shortages requiring rationing of lifesaving medications. Crises can generate opportunities. Mark Cuban, the wildly successful entrepreneur and NBA owner, has committed himself to solving these two problems.

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Rainwater Foundation, CurePSP, Aging Mind Foundation fund innovative tauopathy research

Outsourcing Pharma

The Rainwater Charitable Foundation (RCF), in collaboration with CurePSP and the Aging Mind Foundation (AMF), has announced the allocation of $2 million in grants to support groundbreaking research in primary tauopathies.

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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: Would a bird flu vaccine for cows work?

STAT

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. Happy Monday! Are you watching the Olympics this week? As a former distance swimmer, I’m a big fan of watching Katie Ledecky smoke everyone in the mile.

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NICE blocks Enhertu use after pricing talks break down

pharmaphorum

NICE and pharma groups AstraZeneca and Daiichi Sankyo have been unable to agree on a price for Enhertu in HER2-low breast cancer.

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STAT+: For-profit hospitals are getting a boost from a flood of patients

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. Inside UnitedHealth’s physician empire UnitedHealth Group is everywhere. Increasingly, it is starting to feel like the Standard Oil of health care.

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Biologics contract manufacturing: A comprehensive guide for pharmaceutical companies

pharmaphorum

This comprehensive guide provides pharmaceutical companies with valuable insights into biologics contract manufacturing, including the role of CDMOs and key considerations for successful partnerships.

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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 Sarepta’s demand to censor a video, Roche fast-tracking an obesity pill, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation.

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Ventyx’s TYK2 drug suffers second setback

BioPharma Dive

The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internal trials.

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The biotech news you need 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. Hi there. Today, we learn that Sarepta Therapeutics pressed a patient advocacy group to censor a video containing harsh criticisms of the company — calling into question how the financial ties between biotech companies and advocacy groups impact patients.

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NewAmsterdam obicetrapib data disappoints some investors

pharmaphorum

Shares in NewAmsterdam Pharma were sliding today after it reported a phase 3 trial of obicetrapib that met its primary objective but didn't meet the expectations of some analysts and investors.The BROOKLYN study compared the oral CETP inhibitor to a placebo given on top of maximum tolerated doses of other lipid-modifying therapies, like statins and ezetimibe, in patients with heterozygous familial hypercholesterolaemia (HeFH), a genetic condition that raises blood cholesterol and the risk of hea

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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.