Wed.Jan 29, 2025

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Engineered muscle patch fixed failing hearts in an early study

STAT

By its name and nature, heart failure doesn’t have a good outlook. The progressive disease is diagnosed when the heart is no longer able to pump blood and oxygen throughout the body as well as it should, limiting daily activities and lifespan. Medications have improved at easing its symptoms, including obesity drugs that appear to work by reducing weight and fat, but researchers have long sought a more direct  repair of heart failure’s damage.

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EM Match Advice 46 | Program Directors Share Match Season Insights

ALiEM - Pharm Pearls

As interview season wraps up, medical students across the country are preparing their rank lists for the upcoming Match. EM Match Advice podcast host, Dr. Sara Krzyzaniak (Stanford EM Program Director) recently sat down with Dr. Melissa Parsons (University of Florida College of Medicine – Jacksonville EM Program Director), to discuss the match process from both program and applicant perspectives.

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STAT+: Biotech accelerator Curie.Bio raises $340 million for a new seed fund

STAT

Curie.Bio, the biotech accelerator and investment firm started by Alexis Borisy and Zach Weinberg, has raised another $340 million to invest in startups. Borisy and Weinberg’s firm was created to upend the biotech financing model , offering both capital and expert assistance to founders seeking on option outside of traditional VC funding. The idea has resonated with venture capitalists — several of whom have invested in Curie.Bio — and startups.

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RPS suggests 'opt-in' process for pharmacists participating in assisted dying

The Pharmacist

Pharmacists should be able to opt-in to participate in assisted dying by undertaking the necessary training, rather that having to opt-out of providing the service, the Royal Pharmaceutical Society (RPS) has told MPs. And it stressed that there must be no obligation for any pharmacist to participate in any aspect of assisted dying if they […] The post RPS suggests 'opt-in' process for pharmacists participating in assisted dying appeared first on The Pharmacist.

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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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Opinion: When your child can’t walk and it could be polio

STAT

My son was 5 years old when he climbed out of bed and landed on the floor. He was always a teaser. “C’mon, silly,” I said. “Time to get ready for school.” “Mommy,” Aaron said, very puzzled. “I can’t feel my legs.

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Ozempic approved for chronic kidney disease patients

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Another busy day, so let’s get straight into the news.

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OneSource gains EIR with VAI classification from USFDA for its BLD Facility

Express Pharma

OneSource Specialty Pharma announced that it has received an Establishment Information Report (EIR) with a Voluntary Action Indicated (VAI) status from the US. Food and Drug Administration (USFDA) for its BLD facility in Bengaluru. The report follows a comprehensive inspection of the facility, conducted from November 14 to November 22, 2024. OneSource operates five cGMP facilities and with 138 successful regulatory and customer audits to date by all major regulatory bodies.

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Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

The Hidden Costs Behind Your Generic Medications: What's Driving the Price? As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. But the truth is, there's more to it than meets the eye. The cost of producing generic drugs is influenced by a multitude of factors, and understanding these dynamics can help us better appreciate the affordability of these e

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Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression

Express Pharma

The US FDA has approved Novo Nordisk’s Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD), the Danish drugmaker said on Tuesday. Novo’s blockbuster diabetes drug Ozempic belongs to a class of drugs known as GLP-1 receptor agonists and has the same active ingredient as its popular obesity treatment Wegovy.

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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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Executive hiring changes reflect a broader biotech comeback

PharmaVoice

Executive hiring shifts are often indicators of wider trends in the market. Here’s how the hiring landscape for pharma leaders is changing.

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Positive topline results announced in phase 2 Alcohol Use Disorder study

Pharmafile

Beckley Psytech Ltd, a clinical-stage biopharmaceutical company that specialises in the production of accessible medicines for mental health conditions, has announced positive results for the phase 2a study into BPL-003 in patients with moderate-to-severe Alcohol Use Disorder (AUD). The study, labelled NCT05674929, was conducted at Kings College London and Clerkenwell Health, both UK.

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A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal?

PharmaVoice

Vertex Pharmaceuticals’ non-opioid pain medication is up for FDA approval this week. Other drugmakers have found safer alternatives to expand the pain management landscape.

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Enhancing spectroscopy analysis with machine learning

European Pharmaceutical Review

Researchers have developed and optimised a novel sensing strategy for isomer discrimination by combining advanced spectroscopy with machine learning. The approach is based on surface-enhanced Raman scattering (SERS) substrates (ie, plasmonic platforms). Montes-Garca et al. explained that they fabricated advanced SERS substrates made of quasi-spherical gold nanoparticles (Au NPs) synthesised via a seeded growth method.

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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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Looking for Clues about FDA Under RFK Jr.

FDA Law Blog: Biosimilars

By John W.M. Claud & JP Ellison The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention, Kennedys portfolio will be vast.

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NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

Pharmafile

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to be used as treatment of Duchenne Muscular Dystrophy (DMD) in patients who are aged 4 or older in the UK. The guidance follows the approval of vamorolone from the Medicines and products Regulatory Agency (MHRA) […] The post NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera appeared first on Pharmafil

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Sustainability in Pharmaceutical Outsourcing

PharmaTech

Pharmaceutical Technology spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers.

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FDA clears use of Ozempic to protect kidney health

BioPharma Dive

The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, which hasn’t yet proven it can improve outcomes in kidney disease.

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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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Industry Outlook 2025: Through the Lens of a Service Provider

PharmaTech

Pharmaceutical Technology spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

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How to develop GMP compliant software for quality management

GMPSOP

How to develop GMP compliant software for quality management Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST It has long been identified that if a pharmaceutical manufacturing business can automate its quality management systems using validated and reliable GMP compliant software applications, its productivity and compliance can improve in numerous ways.

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Ozempic is first GLP-1 drug FDA-approved for kidney disease

pharmaphorum

Novo Nordisk's Ozempic has become the first drug in the GLP-1 class to be cleared to prevent worsening kidney disease in type 2 diabetics

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Microbial therapy offers new hope for vitiligo patients

World Pharma News

A natural compound derived from gut-friendly bacteria significantly slows the progression of vitiligo and may restore pigmentation, reports a new Northwestern University pre-clinical study in mice. The findings could offer hope to millions affected by the autoimmune disease, which causes visible patches of skin discoloration and carries profound emotional and physical consequences.

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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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Lyfegen partners EVERSANA on pricing, access resource

pharmaphorum

Lyfegen and EVERSANA have joined forces to help pharma companies navigate an increasingly complex global drug pricing and access environment

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European Drug Shortage Monitoring Platform Fully Operational

PharmaTech

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

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Will European PFAS ban disrupt pharma supply chains?

Pharmaceutical Technology

A proposed ban on PFAS chemicals is being challenged over concerns about potential supply chain disruption in the pharmaceutical industry.

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Budget expectations: Leaders opine for incentives in the nutra and API manufacturing sectors

Express Pharma

Priyanka Chigurupati, Executive Director, Granules India As India’s pharmaceutical industry cements its position as the world’s third-largest by volume, the upcoming Union Budget presents a crucial opportunity to accelerate our transformation into a global healthcare leader. With our industry projected to reach $120-130 billion by 2030, we must address the critical challenge of API dependency.

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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.