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Read Libre Duo FDA Authorisation Through De Novo Pathway
Profile photo of Nicole Dale
Nicole Dale

Libre Duo FDA Authorisation Through De Novo Pathway

Pharmatica editorial close‑up of FDA regulatory submission materials for diabetes devices, featuring a Libre glucose sensor, red insulin pen, and red office stamps and pens on a beige folder labeled, ‘U.S. Food & Drug Administration (FDA) – Regulatory Submission Diabetes Division,’ representing medical‑device approval and diabetes‑management technology.

Abbott’s Libre Duo FDA authorisation creates a new Class II device category, combining glucose and ketone monitoring while setting a regulatory path for future devices.

Medical Devices
Read Where Healthcare AI Investment Is Going — And Where It Isn't
Profile photo of Nicole Dale
Nicole Dale

Where Healthcare AI Investment Is Going — And Where It Isn't

Healthcare AI investment visualisation showing an advanced artificial intelligence network connected to pharmaceutical research, molecular data, and digital health systems. The image represents AI investment trends in healthcare, pharmaceutical innovation, biotech intelligence, machine learning in drug discovery, and the future of healthcare technology.

The data is out: Two-thirds of AI healthcare startup investment went to just three domains. Insight into clinical leadership, gender inclusivity, and geographical access reveals a sector building for investability… not clinical need.

AI & Machine Learning
Read The AI Bioweapons Risk: We Cannot Afford to Look Away
Profile photo of Nicole Dale
Nicole Dale

The AI Bioweapons Risk: We Cannot Afford to Look Away

Abstract visualisation of AI bioweapons risk showing a connected hexagonal network and glowing AI hub, symbolising biosecurity challenges, gene synthesis screening vulnerabilities, biotechnology innovation, and governance in the pharmaceutical industry.

The risk of AI being used to create a bioweapon is a serious concern for pharma biosecurity after researchers found AI-designed toxins can evade DNA screening. Here’s what you need to know about the AI and bioweapons risk.

AI & Machine Learning
Read AI in Pharma: Hype vs. What Actually Works
Profile photo of Shubhangi Dua
Shubhangi Dua

AI in Pharma: Hype vs. What Actually Works

In the recent episode of the Digital Pulse podcast, host Shubhangi Dua, Podcast Producer and B2B Journalist, sat down with Lara Masad, an AI and Data Innovation independent consultant, to clarify the key distinctions in AI and machine learning models. Furthermore, Masad explains how pharmaceutical companies benefit from using AI models.

Expert Lara Masad explains why pharma leaders miscalculate AI investments and how to build a defensible validation strategy.

AI & Machine Learning
Read AI in Pharma: Why the Future of Healthcare Starts With Patients, Not Tech
Profile photo of Shubhangi Dua
Shubhangi Dua

AI in Pharma: Why the Future of Healthcare Starts With Patients, Not Tech

Kate O’Reilly, President & Chair of the Healthcare Businesswomen’s Association (HBA) Dublin-Ireland Chapter & Healthcare Transformation Partner at Roche, discusses AI in pharma, patient engagement, and the future of healthcare innovation.

Kate O’Reilly, President & Chair of the Healthcare Businesswomen’s Association (HBA) Dublin-Ireland Chapter & Healthcare Transformation Partner at Roche, discusses AI in pharma, patient engagement, and the future of healthcare innovation.

AI & Machine Learning
Read Can Large Language Models Solve More Rare Disease Genomes?
Profile photo of Nicole Dale
Nicole Dale

Can Large Language Models Solve More Rare Disease Genomes?

Pharmatica image showing a clinical geneticist using LLM-assisted rare disease diagnosis tools to analyse genome sequencing data and generate evidence-based diagnostic hypotheses for precision medicine.

LLM-assisted rare disease re-assessment improves genomic analysis, increasing diagnostic yield and supporting clinician-led precision medicine and possibly drug development.

AI & Machine Learning
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