These 6 companies are using AI to streamline clinical trials for pharma
STAT
NOVEMBER 7, 2024
In the last year, drugmakers have talked up the prospect of medicines discovered or designed by artificial intelligence.
Thu.Nov 07, 2024
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New NICE guidance clarifies HRT as ‘first line treatment’ for menopause symptoms
The Pharmacist
NOVEMBER 7, 2024
NICE has emphasised the importance of HRT in new guidance and clarified that cognitive behavioural therapy (CBT) should be an ‘add on’ treatment for menopausal symptoms. In its updated guidance, NICE has encouraged healthcare professionals to have ‘informed conversations’ with patients about the risks and benefits of HRT, and included a new ‘discussion aid’ to use […] The post New NICE guidance clarifies HRT as ‘first line treatment’ for menopause symptoms appeared first on The Pharmacist.
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FDA proposes removal of oral Phenylephrine from OTC nasal decongestant products
Express Pharma
NOVEMBER 7, 2024
On 7 November 2024, the U.S. Food and Drug Administration (FDA) announced a proposal to remove oral phenylephrine from over-the-counter (OTC) drugs marketed as nasal decongestants. The proposal follows an agency review that concluded oral phenylephrine is ineffective in providing temporary relief of nasal congestion. Until a final order is issued, however, companies may continue to sell OTC products containing oral phenylephrine for nasal decongestion.
The Impact of Generic Drugs on Healthcare Costs
Drug Patent Watch
NOVEMBER 7, 2024
The rising cost of prescription drugs has become a significant public health concern, with millions of Americans struggling to afford their medications. One crucial factor in mitigating this issue is the increased use of generic drugs. Generic drugs have been instrumental in reducing healthcare costs, and their impact cannot be overstated.
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.
Among 2024’s modest M&A action, cancer, immunology and neuroscience deals trickle in
PharmaVoice
NOVEMBER 7, 2024
Dealmaking this year has been largely muted, but M&A trends are pointing to the areas where pharma is placing the most emphasis.
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New study to assess mpox vaccine in pregnant women and infants
Pharma Times
NOVEMBER 7, 2024
Trial to evaluate safety and efficacy of MVA-BN vaccine
Healthcare Email Marketing Strategies: A Guide for Pharma Executives
Pharma Marketing Network
NOVEMBER 7, 2024
In today’s digital world, healthcare email marketing is more than just sending out newsletters. It’s a strategic tool that, when done right, can boost engagement, nurture relationships with healthcare professionals (HCPs), and increase brand awareness. But how can pharma companies truly maximize the potential of email marketing? Let’s dive in and explore some proven strategies.
Elsevier backs Pistoia Alliance for AI in drug discovery
Pharma Times
NOVEMBER 7, 2024
New initiatives to tackle AI-related challenges in life sciences
FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar
Big Molecule Watch
NOVEMBER 7, 2024
On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada. The filing for HLX14 is supported by data from studies including analytical assessments and two clinical trials.
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
An RNAi renaissance is creating a new generation of startups
PharmaVoice
NOVEMBER 7, 2024
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
Plus Therapeutics partners with SpectronRx for CNS therapy development
Pharmaceutical Business Review
NOVEMBER 7, 2024
This partnership leverages SpectronRx’s advanced facilities for late-stage clinical and commercial supplies of the therapy. SpectronRx and Plus Therapeutics collaboration is set to accelerate nuclear medicine and improve supply chain redundancy for the production of Rhenium (186Re) Obisbemeda to meet upcoming commercial requirements and clinical trials.
Novo sheds kidney drug licensed for $1.3bn a year ago
pharmaphorum
NOVEMBER 7, 2024
Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.
To 513(g) or not to 513(g)? That is the question
FDA Law Blog: Biosimilars
NOVEMBER 7, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sometimes, though, the question of classification defies an easy answer. When a company is unsure if its product is a device, there are a number of resources that can provide the answer, such as the device regulations at 21 CFR parts 800 – 898; any of the databases that cover pr
Why Every Small Business Needs an HCM Solution: A Comprehensive Guide
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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.
Sarepta pulls plug on Duchenne exon-skipping drug
pharmaphorum
NOVEMBER 7, 2024
Sarepta has halted development of vesleteplirsen, a follow-up to its Duchenne muscular dystrophy therapy Exondys 51.
Sarepta scraps a Duchenne drug as gene therapy sales rise
BioPharma Dive
NOVEMBER 7, 2024
Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Now, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.
Webinar recap: Boosting recruitment and retention with SDOH data
pharmaphorum
NOVEMBER 7, 2024
Discover the key takeaways from a webinar focused on boosting recruitment and retention through Social Determinants of Health (SDOH) data. Learn how incorporating SDOH data can enhance your recruitment and retention strategies.
EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
Pharmaceutical Technology
NOVEMBER 7, 2024
The EMA has granted approval for Sanofi/Regeneron’s Dupixent (dupilumab) to treat EoE in children as young as one.
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.
Avid Bioservices to go private in $1.1bn private equity deal
pharmaphorum
NOVEMBER 7, 2024
Nasdaq-listed CDMO Avid Bioservices has agreed a $1.
Novo Nordisk signs $285 million deal for a once-monthly GLP-1 receptor agonist
Outsourcing Pharma
NOVEMBER 7, 2024
Wegovy manufacturer Ascendis Pharma has been tasked with supporting the development of a once-monthly GLP-1 drug.
Blueprint's mastocytosis drug Ayvakit cleared for NHS use
pharmaphorum
NOVEMBER 7, 2024
NICE has recommended broad use of Blueprint Medicines' recently-approved therapy for rare blood disorder advanced systemic mastocytosis
Minister for Science champions partnerships with private clinical sector in UK
Pharmaceutical Technology
NOVEMBER 7, 2024
Lord Vallance stated the government sees investment, innovation, and public-private partnership as crucial to UK healthcare.
Enhance Healthcare Efficiency With Top Payroll & HCM Services
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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.
Are You an Introvert? Consider This Path for Your Pharmaceutical Career
The Script
NOVEMBER 7, 2024
Do you consider yourself an introvert? Our team at Rx relief explains a few pharmaceutical positions you'd thrive in.
DBV Technologies’ stock slides as financial woes worsens
Pharmaceutical Technology
NOVEMBER 7, 2024
The company reported that it does not have sufficient cash reserves to operate for the next 12 months, can only fund operations into Q1 2025.
Metrics for the UK’s VPAG: A work in progress
pharmaphorum
NOVEMBER 7, 2024
Discover the latest metrics and updates on the UK's VPAG (Voluntary scheme for branded medicines Pricing, Access and Growth) from NICE (National Institute for Health and Care Excellence). Stay informed on this work in progress.
Scientists discover how specific E. coli bacteria drive colon cancer
World Pharma News
NOVEMBER 7, 2024
Scientists have uncovered how certain E. coli bacteria in the gut promote colon cancer by binding to intestinal cells and releasing a DNA-damaging toxin. The study, published in Nature, sheds light on a new approach to potentially reduce cancer risk. The study was performed by the teams of Prof. Lars Vereecke (VIB-UGent Center for Inflammation Research) and Prof.
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.
EMCrit RACC Lit Review – October/November 2024
EMCrit Project
NOVEMBER 7, 2024
All the RACC Literature Goodness for November 2024 EMCrit Project by Scott Weingart, MD FCCM.
Senhwa Biosciences starts trial of silmitasertib in children with difficult to treat cancers
Outsourcing Pharma
NOVEMBER 7, 2024
The Taiwanese biotech has launched a phase 1/2 trial to test its small molecule cancer therapy in children and young adults with relapsed or treatment resistant tumors.
Aptamer Extends Agreement for Drug Delivery Vehicles
PharmaTech
NOVEMBER 7, 2024
A genetic medicines customer has selected the company’s binders for commercial development of the customer’s product.
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