Market Access

Uncertainty Remains Over The Future Of Regulatory Data Protection In The EU

Uncertainty Remains Over The Future Of Regulatory Data Protection In The EU

 
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As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.

Korea Lays Out Roadmap For Use Of AI Across Drug Development

Korea Lays Out Roadmap For Use Of AI Across Drug Development

 
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The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.

Transnational Collaborative Health Tech Assessments Have Much To Offer

Transnational Collaborative Health Tech Assessments Have Much To Offer

 

European cross-border HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, say Nordic health technology assessment experts. Talks on HTA collaborations outside Europe are also underway.

Nordic HTA Body Tells Pharma Users: ‘Feel the Fear And Do It Anyway’

Nordic HTA Body Tells Pharma Users: ‘Feel the Fear And Do It Anyway’

 

It is time for companies to take part in cross-country health technology assessments and stop only asking “what’s in it for me?”


Big Pharma Faces A Big Reality Check In Cell And Gene Therapy

Big Pharma Faces A Big Reality Check In Cell And Gene Therapy

 
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Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.

New Pharma Research Law Fails To Make Germany More Competitive Says EUCOPE Head

New Pharma Research Law Fails To Make Germany More Competitive Says EUCOPE Head

 

Germany’s Medical Research Act clears its final legal hurdle after federal council sign off.

Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation

Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation

 
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Policy experts and consultants recount their experiences shepherding manufacturers through the first round of Medicare price negotiations during a recent webinar.

A Race Against Time: Diagnostics Is Key To Tackling AMR

A Race Against Time: Diagnostics Is Key To Tackling AMR

 

Charles Cooper, CMO of the diagnostics firm bioMérieux, talks to In Vivo about the vital nature of partnerships to fight the global AMR crisis.


Changing Chinese Market Dynamics Hit Merck Where It Hurts

Changing Chinese Market Dynamics Hit Merck Where It Hurts

 
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China gets more complicated as multinational drug makers venture deep into it. Even with a local savvy business partner, Merck is learning to navigate through fast-shifting market dynamics amid policy changes, consumer perceptions of foreign brands, and competition from local firms as it takes stock of its market access, pricing and life cycle management strategies.

Bristol Myers Squibb ASPIREs For Access In LMICs

Bristol Myers Squibb ASPIREs For Access In LMICs

 

BMS has launched a new cancer drug access program for low-to-middle income countries, focusing on addressing health inequities and widening accessibility.

Humira Pricing Takes Center Stage In Dutch Courts

Humira Pricing Takes Center Stage In Dutch Courts

 
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A public interest group has accused the pharma major of using excessive pricing to bolster sales of blockbuster Humira, consequently damaging the health of Dutch patients. 

Spain Consults On HTA Regulations

Spain Consults On HTA Regulations

 

New rules on health technology assessments in Spain make room for real-world evidence and early dialog.  


A Map View Of US Biosimilar Uptake

A Map View Of US Biosimilar Uptake

 
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Texas comes out on top for biosimilar uptake, but how do the other US states compare? Geographical data can pinpoint which states are embracing biosimilars, and which have a way to go.   

US Generics Players Enjoy Calmer Waters

US Generics Players Enjoy Calmer Waters

 
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After years of heavy price and cost pressures that have taken a toll on firms operating in the US generics market, more recent quarters appear to have reflected a calmer and more predictable landscape.     

Market Prices Or Political Expediency? Amgen’s US Lawsuit Seen As Litmus Test

Market Prices Or Political Expediency? Amgen’s US Lawsuit Seen As Litmus Test

 
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As the US struggles to contain the cost of prescription medicines, a growing number of state governments are trying to take matters into their own hands and believe prescription drug affordability boards could be the answer.

The Future Of Medical Evidence Generation

The Future Of Medical Evidence Generation

Boston Consulting Group and senior pharma industry executives take a broad look at the challenges and opportunities for medical affairs evidence generation with multiple modalities.


Market Access Strategies: Nudging Negotiations Along

Market Access Strategies: Nudging Negotiations Along

 
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Deals in pharma to secure market access are now business as usual. More deals will be needed in future too. Yet they take time and are not easy to successfully conclude. Could nudging the negotiations help?

Why EU App Makers May Need A Notified Body More Often Than They Realized

Why EU App Makers May Need A Notified Body More Often Than They Realized

 

Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.

Mpox: WHO Steps Up Calls For Urgent Prevention And Vaccination Efforts

Mpox: WHO Steps Up Calls For Urgent Prevention And Vaccination Efforts

 
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National authorities urged to address knowledge gaps and generate evidence about the dynamics of mpox transmission.

Medtechs Worry That Europe’s Biggest Killer Could Escape Their Grasp

Medtechs Worry That Europe’s Biggest Killer Could Escape Their Grasp

 
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The European Alliance for Cardiovascular Health is three years old in September. Its remit to improve patient health has attracted strong support from stakeholders, but more investment and attention are required to ensure its momentum towards implementation is not lost. Experts at MedTech Forum 2024 explained what is at stake.