Fri.Mar 22, 2024

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FDA authorizes new drug to protect immune compromised from Covid-19

STAT

The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals against Covid-19.  The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023. New Omicron variants had rendered Evusheld ineffective.

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SAEM Clinical Images Series: Seeing Double

ALiEM - Pharm Pearls

A 53-year-old woman with no significant past medical history presented to the emergency department with a 3-day history of double vision on leftward gaze. She initially presented to urgent care with a chief complaint of chest heaviness and concern that her blood pressure was too high, but was sent to the emergency department for further cardiac and neurological evaluation after her urgent care provider noticed abnormal eye movement.

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Pregnancy increases biological age — but recovery and breastfeeding can undo the damage, study finds

STAT

Pregnancy is a known stressor on the body. But a new study published on Friday in Cell Metabolism found that while pregnancy accelerates the body’s biological clock, much of that effect is reversed after delivery, especially in people who breastfeed. The results add to growing evidence that molecular aging, a process by which our cells accrue damage and dysfunction over time, doesn’t progress in a linear fashion — nor only forward.

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This pharma ‘fixer’ is now leading the charge in the Gates foundation’s tuberculosis battle

PharmaVoice

After getting her start as a nurse, Debra Weiss worked her way up the corporate ladder and is now COO of Gates MRI, which just launched its first phase 3 trial for tuberculosis.

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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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Male birth control research wins audience over at STAT Madness event

STAT

What happens when too many excellent, pioneering researchers enter a room? A little madness. That’s what attendees at the Breakthrough Summit East in New York had on their hands Thursday, as four participants presented their work in this year’s STAT Madness competition — an annual March Madness bracket-style battle to find the best innovation in science and medicine.

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FDA clears first-of-its-kind Duchenne drug for broad use

BioPharma Dive

The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.

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More Trending

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FDA approves Idorsia’s Tryvio for treatment of high blood pressure

Pharmafile

Idorsia has announced that the US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on prior treatments. The drug is an ‘endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 […] The post FDA approves Idorsia’s Tryvio for treatment of high blood pressure appeared first on Pharmafile.

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STAT+: Despite new Wegovy coverage, Medicare patients may face high drug costs and other hurdles

STAT

Medicare confirmed this week that it will cover Novo Nordisk’s obesity drug Wegovy if prescribed to prevent heart problems, but policy experts said Medicare patients are still likely to encounter significant barriers getting access to the highly popular and expensive drug. Medicare previously wasn’t reimbursing for Wegovy, since the federal payer is legally barred from covering weight loss drugs.

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The 3 biggest mistakes we keep making in clinical operations

pharmaphorum

Explore the three major mistakes commonly made in clinical operations that impact patient care, clinical research, and data integrity. Learn how to avoid these pitfalls for successful clinical operations.

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STAT+: Drug development was once a marathon. New tools and timelines are turning it into a sprint

STAT

Drug development is more of a sprint than a marathon these days, thanks to more and better ways to target underlying biology and a more nuanced interpretation of precision medicine, three biotech leaders said at the STAT Breakthrough Summit East in New York Thursday. “We used to say, well, you may spend five years in the research phase, another five in development.

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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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PAP 2024: Amy Niles Discusses Goals of the PAN Foundation

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, The PAN Foundation discusses the overall mission of the organization.

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Opinion: STAT+: Medical devices makers are trying to take a page from Uber’s playbook

STAT

In a recent survey of U.S. companies, medical device makers reported spending $31 million on average to bring a new product to market under the Food and Drug Administration’s 510(k) pathway for those similar to devices already approved. These costs balloon to more than $90 million for new Class III devices that progress through the more rigorous premarket approval pathway.

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Heart claims unlock Medicare coverage of obesity drugs

pharmaphorum

Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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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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Digital diabetes tools ‘of little benefit and raise costs’

pharmaphorum

First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs

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STAT+: How a for-profit health system’s push to expand ended in disappointment for a tiny island nation

STAT

Protesters in the tiny Mediterranean nation of Malta converged last October on the 18th-century Baroque palace housing the prime minister’s offices chanting “thieves,” and unfurled a massive banner on the steps emblazoned with the words: “Bring back the €400 million now.” The object of their furor wasn’t just the government.

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Pharmacist Guide to Managing Fever

FADIC

Pharmacist’s Guide to Managing Fever: A Systematic Approach to Patient Evaluation and Counseling What is fever? A fever is defined as having a body temperature greater than the normal core temperature of 100°F (37.8°C). Normal body temperature can fluctuate and average between 97.5°F (36.4°C) and 98.9°F (37.2°C). Fever is a very prevalent symptom that is often recognized as one of the chief causes of visits to the emergency department or pediatrician for patients younger than 15.

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STAT+: How biotech investors spot opportunity when stocks are down — and up

STAT

Following a blockbuster year of dealmaking and a recent uptick in biotech stocks, top investors see more good news on the horizon. Driving the momentum? Economics 101. Biotechs rely on borrowing capital, which is a more tenuous task when interest rates are high. But interest rates have most likely peaked, with Federal Reserve officials signaling earlier this week they expected to make three cuts this year.

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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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Combination treatment could minimise cancer relapse risk

European Pharmaceutical Review

Research suggests that combining ribociclib with hormone therapy improved invasive-free survival in stage 2 or 3 HR-positive, HER2-negative early breast cancer. The study data showed that distant disease-free survival and recurrence-free survival improved when the small molecule CDK4/6 inhibitor ribociclib was used alongside a nonsteroidal aromatase inhibitor (NSAI).

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EU adviser says Illumina merger was not problematic

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, it’s Meghana. Today, Illumina finally finds an advocate in the EU, a CRISPRed pig kidney is transplanted into a living human, and more.

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Vitamin D and Gut Health: Revealing the Vital 6-Point Link

Welltopia Pharmacy

Understanding the Link Between Vitamin D and Gut Health Vitamin D and Gut Health: Maintaining optimal gut health is essential

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STAT+: Pharmalittle: We’re reading about Medicare and obesity drugs, FDA syringe warnings, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda so far appears quite modest. We plan to catch up on our reading, take a few needed naps and promenade with the official mascots, weather permitting. We also hope to hold another listening party where the rotation will likely include this , this , this , this and this.

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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 okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

pharmaphorum

Italfarmaco’s non-steroidal drug Duvyzat (givinostat) has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD)

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Revolutionising outcomes: Agile CROs lead the way

Express Pharma

Clinical trials attest to the safety and efficacy of pharmaceuticals. But, they’re not cheap to conduct. By 2020, out of the mammoth $200 billion pumped into pharma research, a whopping $48.4 billion went into clinical trials. Given the current trajectory, the figures could balloon to $68.9 billion by 2025 and approach $84.44 billion by 2030. CROs: The torchbearers To strike a balance between quality and cost, global pharmaceutical giants have, since 2005, leaned towards Indian clinical re

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Innovate UK awards ten projects over £6m to develop new clinical tools for dementia

Pharma Times

Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year

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Idorsia first-in-class hypertension drug gets FDA okay

pharmaphorum

Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist class for that indication.

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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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Three Digital Intake Strategies For Eliminating Patient Enrollment Forms

Drug Channels

Today’s guest post comes from Adam Stotts, SVP of Customer Success at AssistRx. Adam discusses how patients seeking to access specialty therapies can benefit from a digital intake approach. He then explains three ways that specialty pharmaceutical companies can use digital intake strategies to speed patient enrollment. To learn about AssistRx’s digital intake solutions, download Digital Intake for Specialty Drug Programs: Q1 2024 Progress Report.

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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.

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Make it easier to open new pharmacies, says Tory MP

The Pharmacist

Licensing new community pharmacy premises should be made ‘as convenient as possible’ for contractors, Conservative MP for South Swindon Sir Robert Buckland has told The Pharmacist. And the sector must be supported to deliver ‘frontline’ healthcare services like Pharmacy First, he said. Speaking to The Pharmacist at the recent Fight4Pharmacies event outside parliament, Sir Robert […] The post Make it easier to open new pharmacies, says Tory MP appeared first on The Pharmacist.

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Mirador’s massive $400m first round, and other financings

pharmaphorum

It has been a bumper week for biotech financings, with a $400m Series A for Mirador heading, topping impressive rounds for Capstan, Clasp, Engrail, Enliven, and Nouscom.

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FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

Pharmaceutical Technology

The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

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