November, 2024

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Airways unbound: The biologic revolution in asthma treatment  

Pharmaceutical Technology

In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.

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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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DSCSA Compliance Strategies: How Business Networks Are Transforming Pharma Logis.

Pharma IQ

Explore strategies for DSCSA compliance with insights from Aladdin Mandishah, Director of Product Marketing at SAP.

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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

When the General Data Protection Regulation (GDPR) 1 came into effect in 2018, this appeared to accelerate the migration out of Europe for pharmaceutical clinical trials. This was not so much due to non-compliance but stemmed from regulatory ambiguity. As the EU now sets its sights on the regulation of artificial intelligence (AI) through the EU Artificial Intelligence Act (EU AI Act), 2 similar questions arise regarding the implementation and enforcement of the regulation.

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Enterprise ABM Marketing Tools: A Marketer's Guide

Savvy B2B marketers know that a great account-based marketing (ABM) strategy leads to higher ROI and sustainable growth. In this guide, we’ll cover: What makes for a successful ABM strategy? What are the key elements and capabilities of ABM that can make a real difference? How is AI changing workflows and driving functionality? This Martech Intelligence Report on Enterprise Account-Based Marketing examines the state of ABM in 2024 and what to consider when implementing ABM software.

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Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases

MedCity News

Synapticure’s Series A round was led by B Capital and included participation from CommonSpirit Health, CVS Health Ventures and RA Capital. The post Synapticure Secures $25M To Scale Virtual Care for Neurodegenerative Diseases appeared first on MedCity News.

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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More Trending

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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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AZ confirms China president has been detained

pharmaphorum

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities

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GLP-1 receptor agonists aid broader outcomes in kidney disease, major analysis finds

European Pharmaceutical Review

Glucagon-like peptide-1 (GLP-1) receptor agonists have shown to provide meaningful benefits in chronic kidney disease (CKD) and individuals with and without diabetes. This based on the largest, most comprehensive analysis of GLP-1 antagonists on kidney and cardiovascular outcomes. While GLP-1 receptor agonists have shown benefit for type 2 diabetes, obesity and cardiovascular disease, its impact as a treatment in chronic kidney disease is not as clear, the researchers explained.

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Market Trends to Watch for Health Systems and Their Specialty Pharmacies

MedCity News

The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. The post Market Trends to Watch for Health Systems and Their Specialty Pharmacies appeared first on MedCity News.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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CEO with type 1 diabetes works to deliver ‘world’s first’ functional cure

PharmaVoice

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

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Accelerating Discovery and Development with Advances in High-Throughput Screening

PharmaTech

Automation, miniaturization, and new software algorithms are improving throughput and accuracy.

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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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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AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

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This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths

MedCity News

Endoscopy, the standard for detecting esophageal precancer, is quite an invasive procedure — so a lot of people who should be screened end up never being tested. Lucid Diagnostics is trying to solve this problem by selling a quick, office-based diagnostic. The post This Pill-Size Diagnostic Seeks to Prevent Thousands of Esophageal Cancer Deaths appeared first on MedCity News.

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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

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First-of-a-kind EU approval granted for eosinophilic esophagitis medicine

European Pharmaceutical Review

Dupixent (dupilumab) has been approved by the European Medicines Agency (EMA) as the first treatment for young children with eosinophilic esophagitis in the EU. This authorisation is based on Phase III data which found that 68 percent of children aged one to 11 years given Dupixent (dupilumab) achieved histological disease remission at 16 weeks. This result was maintained for up to one year.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

Fierce Pharma

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

Medicine 311
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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

Sales 111
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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

FDA 105
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WTW: There’s A Disconnect Between Employers and Employees on Wellbeing Programs

MedCity News

Employers are prioritizing mental wellbeing programs, but employees say they need financial wellbeing support, according to a survey from WTW. The post WTW: There’s A Disconnect Between Employers and Employees on Wellbeing Programs appeared first on MedCity News.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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What RFK Jr.’s influence could mean for pharma

PharmaVoice

Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.

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Top-10 Best Practices for Virtual Publication Planning and Development

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The landscape of publication planning is constantly evolving with the rise of novel digital tools, artificial intelligence, and virtual collaboration platforms. As a result, traditional barriers to effective and efficient publication planning and development are being broken down, while new challenges related to compliance, data security, and global collaboration in the virtual setting have emerged.

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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

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NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

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4 AI Hacks to Make Sales Teams More Efficient

Over the last two years, there’s been a 76 percent increase in AI adoption across sales organizations. The reason for its rise? AI increases teams’ productivity by predicting and automating actions that require manual effort. In other words, the research that takes reps hours, AI can do in seconds. For sales teams, AI opens up a world of new possibilities, including automating outreach, identifying best-fit buyers, and keeping CRMs flush with fresh data.

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Ultra-processed food is causing a boom for obesity drug Ozempic

Pharmaceutical Technology

The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.

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How One Optum Exec Is Handling the Influx of Digital Mental Health Solutions

MedCity News

There has been a surge in digital mental health solutions, making it difficult to know which ones are effective. One Optum exec weighed in on how she’s managing this challenge. The post How One Optum Exec Is Handling the Influx of Digital Mental Health Solutions appeared first on MedCity News.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

Medicine 104
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?

European Pharmaceutical Review

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. With the recent failure of Lykos’ trial, how do you see the future of psychedelic therapies in research, especially in treating disorders like depression, PTSD, and substance use diso

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten