Mon.Jan 06, 2025

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STAT+: FDA’s new guidance on AI in drug development centers the risk introduced by the technology

STAT

After nearly a decade of machine learning innovation in the drug industry, the Food and Drug Administration Monday published its first draft guidance on the use of artificial intelligence in the development of drugs and biological products. The guidance comes as drug regulatory submissions citing AI have increased exponentially. In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has r

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PBMs have evaded lawmakers’ reform attempts so far. Could 2025 turn the tide?

PharmaVoice

How regulators could hit PBMs from multiple sides in the coming year.

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STAT+: Pharmalittle: We’re reading about Novo and GLP-1 compounding, Paxlovid and long Covid, and more

STAT

Good morning, everyone, and welcome to the new year. We are returning from an extended respite and hope that you similarly had an opportunity to power down and refresh over the past week or so. Of course, all good things must come to an end, so time to confront the usual routines once again. We understand this may be difficult, but perhaps firing up the coffee kettle for a cup of stimulation can help.

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SAEM Clinical Images Series: Xylazine Wounds

ALiEM - Pharm Pearls

A 32 year-old male with PMH significant for opioid use disorder, a prior admission in 2021 for left-sided empyema s/p thoracotomy and decortication, gas bacteremia, and tricuspid endocarditis presented for a left leg wound. The patient reported a wound to his left leg that had become larger over the past 5 months. The pain worsened today, prompting him to come to the emergency department for evaluation.

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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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Why Medicaid cuts could be a ‘crisis’ for people with disabilities

STAT

Americans want Medicaid. The waiting list to receive home- and community-based services through the state-federal health program has hovered around 700,000 people in recent years. A line that long would stretch from Cleveland to Chicago. The queue may get longer.

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Government will 'maximise' pharmacy ear, nose and throat services under elective care plan

The Pharmacist

The government has committed to 'maximising' Pharmacy First approaches to ear, nose and throat (ENT) health as part of its elective care plan, published today. Prime Minister Sir Keir Starmer laid out the new elective reform plan this morning, which sets out a whole system approach to meeting the 18-week referral to treatment target for […] The post Government will 'maximise' pharmacy ear, nose and throat services under elective care plan appeared first on The Pharmacist.

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A dark anniversary and the last two weeks in health news

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! I hope you had a restful new year. I rang in 2025 with my best friends, whom I love even though they made fun of my ASMR preferences. Found family, you know!?

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4 closely-watched FDA approval dates in 2025 from Vertex, Novo, J&J and more

PharmaVoice

A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.

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Amgen’s lung cancer treatment gets conditional approval

Pharma Times

IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer

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NMD Pharma’s Charcot-Marie-Tooth disease treatment granted ODD by FDA

Pharmafile

Biotech company NMD Pharma has announced that the US Food and Drug Association (FDA) have granted its Charcot-Marie-Tooth (CMT) disease treatment NMD670 orphan drug designation (ODD). NMD670 was previously granted ODD by the FDA for generalised myasthenia gravis in September 2022. NMD670 is a small molecule inhibitor of the skeletal muscle-specific chloride ion channel CIC-1. […] The post NMD Pharmas Charcot-Marie-Tooth disease treatment granted ODD by FDA appeared first on Pharmafile.

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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 prostate cancer test cuts biopsies by 50% in US

Pharma Times

EpiSwitch PSE shows promise in reducing unnecessary procedures

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Orbis raises $93M to turn popular biologics into pills

BioPharma Dive

The startup is developing a kind of macrocyles, which share strengths of both small molecules and biologics, as oral medicines against “validated blockbuster biologic targets.

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MSD buys Irish vaccines plant from WuXi for €500m

pharmaphorum

MSD has expanded its presence in Ireland with an agreement to buy a vaccines manufacturing facility from WuXi Biologics in Dundalk.

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Navigating future biopharma catalysts: What to expect at the 2025 J.P. Morgan Healthcare Conference

BioPharma Dive

The stage is set for JPM 2025—don't miss expert reactions following 2025’s principal catalyst event!

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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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Goals of the Association for Prescription Psychedelics

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), provides a peek into what the association has set out to accomplish.

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Novo Nordisk asks FDA not to allow GLP-1 compounding

pharmaphorum

Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

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Sun Pharma opens training & production centre in Jammu

Express Pharma

As a part of its CSR vision, Sun Pharma inaugurated a Sewing Training-cum-Production Centre in Samba, Jammu in collaboration with the NGO, Usha International. This initiative aims to aid 25 women from low-income groups in the area, by enhancing their skills and promoting micro-enterprises. As part of the programme, participants will receive 25 days of intensive training in sewing and stitching.

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UK public urged to take up flu jabs as cases surge

pharmaphorum

The NHS is dealing with a major rise in influenza cases, with the number of hospitalised patients quadrupling to around 5,000 ahead of the New Year.

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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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5 FDA decisions to watch in the first quarter of 2025

BioPharma Dive

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

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NeOnc Technologies has another go at a Nasdaq listing

pharmaphorum

US biotech NeOnc Technologies has applied to list on the Nasdaq as it advances a portfolio of drugs to treat diseases affecting the CNS.

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New method tracks the 'learning curve' of AI to decode complex genomic data

World Pharma News

Introducing Annotatability - a powerful new framework to address a major challenge in biological research by examining how artificial neural networks learn to label genomic data. Genomic datasets often contain vast amounts of annotated samples, but many of these samples are annotated either incorrectly or ambiguously.

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Focusing too many R&D resources on one drug: The hidden costs of clinical trial-level decision-making

pharmaphorum

Focusing too many R&D resources on one drug: The hidden costs of clinical trial-level decision-making Nicole.

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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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Roche to advance potentially best-in-class antibody drug conjugate

European Pharmaceutical Review

Roche and Innovent Biologics, Inc. have agreed to collaborate to advance development of an innovative DLL3-targeted antibody drug conjugate (ADC) candidate. Innovent shared that this collaboration focuses on advancing treatment options in advanced small cell lung cancer. Innovent will receive an upfront payment of $80 million. The biopharmaceutical company is eligible for up to $1 billion in milestone payments and certain royalties on net sales.

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UK plan to tackle waiting lists includes NHS App upgrade

pharmaphorum

More community hubs and changes to the NHS App are at the core of the UK government's new elective reform plan.

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An evolution in leadership and vision for this pharma company

BioPharma Dive

Esperion CEO Sheldon Koenig reflects on personal challenges and advancing innovative heart therapies.

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Keeping local affiliates on track with pharmacovigilance

pharmaphorum

While marketing authorisation holders (MAHs) are striving to standardise PV processes as much as possible, experience shows that they must balance the global needs with local requirements and barriers, such as resource issues at the local level.

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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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Orbis Medicines bags €90 million Series A to develop oral competitors of biologics

Outsourcing Pharma

Orbis Medicines secures 90M Series A to develop innovative oral macrocycles, offering cost-effective alternatives to biologic drugs and targeting chronic disease markets.

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MVE Biological Solutions Registers Production Plants with the FDA

Pharmaceutical Commerce

The moveone that meets industry standardsconfirms the Cryoport companys commitment to providing quality and safety in the cold chain solutions space.

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Drug Patent Expirations for the Week of January 5, 2025

Drug Patent Watch

TRILIPIX (choline fenofibrate) Abbvie Patent: 7,259,186 Expiration: Jan 7, 2025 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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Pharma Pulse 1/6/25: Building a World-Class Bioscience Ecosystem, Student Pharmacists Can Help End the HIV/AIDS Epidemic & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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.