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A GenAI Copilot For The Regulatory Affairs Team

A GenAI copilot for biopharma regulatory requirements could yield significant returns.

Artificial Intelligence Regulatory

16 Key Trends Reshaping The Future Of Medtech

Record attendance at the 2024 MedTech Forum in Vienna heard industry leaders voice optimism grounded in realism about future developments for Europe’s medtech industry, markets and delivery of care to patients. In Vivo filtered out 16 trends to watch.

Market Access Regulatory

Moving Towards A Total Lifecycle Regulatory Approach For AI Devices

Proportionately regulating highly adaptive AI as a medical device can be done with predetermined change control plans. The US, UK and Canada are advancing the concept, as Ropes & Gray and the US FDA explained.

Market Access Artificial Intelligence

Greater Bay Area Device Adoption Can Be A Steppingstone To China Uptake

Medical devices selected for use in the Guangdong-Hong Kong-Macao Greater Bay Area may potentially be fast-tracked for adoption across mainland China, according to a new industry white paper.

China Hong Kong

‘Pharma Is Not Just A Cost Component’ – Showcasing Value As Well As Innovation

Astellas Pharma’s chief commercial officer discusses the biopharma industry’s responsibility to drive change in health care.

Market Access C-Suite Speaks

Is The IRA’s Impact On Innovation Being Overstated?

With the passage of the Inflation Reduction Act, many have questioned whether Medicare price negotiations will stifle small molecule innovation.

Market Access Regulation

US FTC Targets Pharma Patent Abuse: What You Need to Know

The FTC is intensifying its crackdown on pharmaceutical companies' misuse of patent listings as industry seeks clearer guidelines.

Patents Business Strategies

For BMS, Launching New Products Is The Start Of The Battle

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve access to lifesaving therapies. Payers and politicians must be persuaded to loosen their purse strings – and open their minds.

C-Suite Speaks Business Strategies

Winds Of Change Must Blow Through Welsh Health Care – Digital Chief At BioWales 2024

Wales must be better at adoption, said Mike Emery, the Welsh government’s digital and innovation officer for health and social care, in conversation with In Vivo.

United Kingdom Market Access

No Silver Bullet For Making Medicines Packaging Sustainable

Industry is researching alternatives to PVC for medicines packaging, but content integrity must remain paramount, says Circpack consultancy’s Filipe Viera de Castro, who puts the case for companies to contribute to waste management costs.

Market Access Consumer

Helping Organizations Deliver On KPIs And Giving Staff A Voice

ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.

Rising Leaders Medical Device

As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure

The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.

Market Access Gene Therapy

FDA-EMA Advice Pilot For Complex Generics: What Does Industry Have To Say?

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

Regulation Generic Drugs

The Sustainability Stakes Are Rising: ‘We Cannot Recycle Our Way Out Of This’

The journey to Net Zero, described as ‘the defining issue of our time,’ will get harder in the coming decade. Failure to keep up the pressure will result in more long-term health conditions, increasing deaths and higher costs. The UK NHS is a Net Zero exemplar globally, but without a systemic approach, its compliance efforts could stutter.

Sustainability Medical Device

Coming Of Age: Pharma’s Influencer Marketing Matures

Influencer marketing has emerged as a potent tool for many industries and is a sector set to be worth $22bn in its own right by 2025.

Telehealth Ad Campaigns

An Ecosystem For Medtech Funding And Innovation Support – BioWales 2024

Creo Medical and Clinithink are among the healthtech innovators who have benefited from funding and advisory support offered by the Development Bank of Wales. All three gave a take on the current funding environment at BioWales in London 2024.

Market Access United Kingdom
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