Fri.Oct 04, 2024

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Rwanda to receive experimental vaccines, therapeutics to combat Marburg outbreak

STAT

Experimental vaccines and therapeutics to combat the deadly Marburg virus will begin arriving this weekend in Rwanda, where they will be used in clinical trials expected to begin soon, a U.S. government official confirmed on Friday. There are currently no licensed vaccines or drugs to prevent or treat Marburg, a cousin of the Ebola family of viruses that transmits and causes illness in the same way as Ebola.

Vaccines 364
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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?

PharmaVoice

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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Trending Sources

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STAT+: Q&A: AI is coming for lots of jobs. What about that of the cancer researcher?

STAT

Sam Altman, co-founder of OpenAI and co-creator of ChatGPT,  keeps saying artificial intelligence will help cure cancer. Altman’s going further these days, envisioning a future where an AI essentially replaces the principal investigator. In a discussion last month that was widely circulated this week on social media, Altman recounted chatting with a cancer researcher about a time when an AI would issue experimental plans and tasks to human scientists to complete.

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An Alzheimer’s drugmaker is accused of data manipulation. Should its trials be stopped?

BioPharma Dive

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

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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+: Medicare Advantage market expected to grow in 2025, despite big changes from insurers

STAT

Next year’s Medicare Advantage market will be two things at once: remarkably stable broadly, but rife with changes under the surface. Health insurance companies will still offer older adults a lot of plan choices with low, or completely free, premiums. That’s why the federal government expects enrollment in the $500 billion Medicare Advantage program to grow once again in 2025 — a stark contrast from insurers’ cries that modest payment reforms would damage them and se

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Opinion: Congress can prevent deaths from cardiac arrest if it acts now

STAT

You’ve probably heard of Damar Hamlin, who as starting safety for the Buffalo Bills has helped lead his team to a 3-1 record to start the National Football League season. Damar survived a cardiac arrest during a Monday Night Football game in January 2023, with more than 60,000 people watching in person and another  23 million  tuned in.

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Government 'discussing' hub-to-patient model with CPE

The Pharmacist

The government will 'continue to discuss' issues raised around its proposed hub-to-patient model of hub and spoke dispensing with the community pharmacy negotiator, Community Pharmacy England (CPE) has said. And it suggested briefing new ministers before changes could be implemented 'could take some time'. Hubs could 'disrupt' community pharmacy market without controls In a statement […] The post Government 'discussing' hub-to-patient model with CPE appeared first on The Pharmaci

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STAT+: Exact Sciences wins FDA approval for improved stool-based colon cancer test

STAT

Exact Sciences won Food and Drug Administration approval on Friday for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants.

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FDA approval give BMS an edge in NSCLC treatment

pharmaphorum

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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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: It’s time for a new medical specialty in asynchronous care

STAT

As primary care physicians, we see a scene play out almost daily. A patient is sitting in front of us, explaining her symptoms: She could have difficulty breathing, stress at home, fatigue. We know there is nothing more important than being fully present. However, our minds and eyes keep darting to the computer screen and the growing inbox of messages from other patients: “I forgot my Lipitor for a week, should I double up tomorrow?

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Mounjaro and Zepbound shortages over, declares FDA

pharmaphorum

FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.

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After a rocky debut for new RSV tools, hopes are high as a new season approaches

STAT

Georgina Peacock vividly remembers a night when she admitted 20 babies, all struggling to breathe, into the hospital where she was doing her pediatric medical training. The illness that was robbing them of breath? Respiratory syncytial virus, or RSV. Peacock and many others who are responsible for the care of the country’s youngest children have been moving heaven and earth for the past year and a bit, to make experiences like that a thing of the past.

Hospitals 314
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Navigating the changing pharma landscape with innovation

Express Pharma

The Indian pharma industry, long hailed as a global powerhouse, finds itself at a crossroads. Once a beacon of growth and profitability, the sector is now grappling with a complex web of challenges that are eroding margins and inflating overheads. Pressure on margins: A reality check for India Pharma In recent years, Indian pharmaceutical companies have seen a substantial decline in profitability, dropping by approximately 20-30 per cent over the past six to eight years, aside from a brief surg

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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+: Pharmalittle: We’re reading about an Italian acquisition, Medicare Advantage market growth, and more

STAT

A pleasant Friday morning to you! Adam Feuerstein, here, reporting from the Pharmalittle campus, temporarily relocated to Cambridge, Mass., as your regular New Jersey host Ed takes the day off. Like the one-and-only Mr. Pharmalot, I enjoy my daily headlines with a hot cup of joe. Have a great weekend.  Italian pharma company Recordati said it will buy from Sanofi the global rights to an approved drug to treat cold agglutinin disease , a rare autoimmune disorder, for $825 million, Reuters re

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Indoco Remedies receives U.S. FDA approval for generic Cetirizine tablets

Express Pharma

Indoco Remedies has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). The product is a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg, produced by Johnson & Johnson Consumer Inc.

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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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Messe Muenchen India concludes Analytica Anacon India and Pharma Pro&Pack Expo 2024

Express Pharma

Messe Muenchen India successfully wrapped up the largest edition of Analytica Anacon India, India Lab Expo, and Pharma Pro&Pack Expo at HITEX Exhibition Centre, Hyderabad, held from September 26th to 28th, 2024. The triad event emerged as a key platform for the laboratory, analytical, and pharmaceutical industries, attracting international and home-grown manufacturers, suppliers, pharma companies, research labs, consultants, industry experts, and government officials.

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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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WuXi looks to sell assets as BIOSECURE Act looms

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Hello, hello. Today we talk about whether the AI overlords will commandeer cancer research (on top of everything else in this world), WuXi is looking to sell some of its operations, ostensibly because of the BIOSECURE Act, and more.

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Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma

World Pharma News

AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patie

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Morning Rounds: Hurricane Helene’s impact on health care; Vance on health insurance

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Today’s item on bacterial outbreaks linked to hospital ice machines reminded me of The National’s song “Ice Machines,” so pardon me for slipping into music recommendation mode for a second.

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Enhancing intestinal drug delivery with Quality by Design

European Pharmaceutical Review

A study has reported an approach for optimising metronidazole colonic delivery systems, to increase their potential efficacy when treating diverticulitis. Researchers developed intestinal colon-coated sustained-release matrix metronidazole tablets, using a Quality by Design (QbD) approach. Arévalo-Pérez et al. noted that metronidazole is a synthetic nitroimidazole and has activity against anaerobic bacteria.

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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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Women in Science - SCIEX Rebekah Sayers' on encouraging curiosity

Outsourcing Pharma

Rebekah's father passed on his passion for science and problem solving to her and much her of childhood was spent doing fun hands-on activities from taking apart household mechanics to building rockets.

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Editas trades part of Vertex CRISPR therapy licencing rights deal for $57m

Pharmaceutical Technology

Amidst the long-running Cas9 patent battle, Editas Medicine has struck a deal to sell a portion of its future revenue…

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Innovative Models for Improving Access and Visibility for Specialty-Lite and Retail Therapies

Drug Channels

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx. Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

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My 2024 Jimmy Fund Walk

The Honest Apothecary

Founded in 1947 with a mission to provide compassionate care while pursuing cutting-edge research to combat cancer, Dana-Farber Cancer Institute, is a world leader in cancer treatment and research. One of its most notable fundraising events is the Jimmy Fund Walk, which began in 1989.

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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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How specialized vendors improve patient recruitment success

Outsourcing Pharma

Patient recruitment is a critical and often challenging aspect of clinical trials, particularly for biopharmaceutical companies seeking to accelerate drug development.

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CPHI Milan 2024: Compliance and Automation in Aseptic Processing

PharmaTech

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

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From CDMOs to artificial intelligence - what's the latest in the world of outsourcing?

Outsourcing Pharma

Outsourcing Pharma sat down ahead of CPHI with Dr Andreas Raabe, CEO of Adragos Pharma, to explore the evolving world of pharmaceutical outsourcing.

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