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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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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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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Signal-Based Selling: How to Leverage 4 Key Buying Signals

As prospects define their problem, search for solutions, and even change jobs, they are generating high-value signals that the best go-to-market teams can leverage to close more deals. This is where signal-based selling comes into play. ZoomInfo CEO Henry Schuck recently broke down specific ways to put four key buying signals into action with the experts from 30 Minutes to President’s Club.

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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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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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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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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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Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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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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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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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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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.

Patients 124
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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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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.

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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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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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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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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.

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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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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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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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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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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 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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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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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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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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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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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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Activating Intent Data for Sales and Marketing

Sales and marketing leaders have reached a tipping point when it comes to using intent data — and they’re not looking back. More than half of all B2B marketers are already using intent data to increase sales, and Gartner predicts this figure will grow to 70 percent. The reason is clear: intent can provide you with massive amounts of data that reveal sales opportunities earlier than ever before.