Global Vision

An Irregular Regulatory Agency: Industry Contends With An Unpredictable FDA

 

A series of surprise rejections has made for an FDA that drug and vaccine manufacturers are finding much harder to read than in years past.

Biotech Britain Vs. The World

 
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Industry leaders share how Britain can strengthen its biotech ecosystem, from capital and regulation to talent and ambition, and what the sector could look like by 2030.

‘This Can Be Weaponized’ – Sandoz Sounds Alarm Over Cheap Chinese Antibiotics

 
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As India implements minimum import prices for certain antibiotics and key starting materials, Sandoz's Simon Goeller speaks to Generics Bulletin about the potential for Chinese suppliers to dominate the world market and weaponize supply.

How Asia’s Biopharma Transformation Is Reshaping Global Deal Flow

 
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A decade ago, China was buying Western drugs. Now it is selling them. Executives who ignore the shift do so at their peril.


Big Promises, Long Timelines – Trump’s US Pharma Investment Push

 

While investment promises appear to be in billions of dollars, industry experts remain skeptical.

Accelerated Approvals Perked Up While US FDA Excelled At Being Average In 2025

 

Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.

How One Biotech Built A Three-Continent Model To Navigate US-China Tensions

 
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Pilatus Biosciences' Switzerland-Taiwan-US structure exemplifies how biotechs might navigate US-China tensions, leveraging Chinese manufacturing efficiency while maintaining American investor credibility and partnership opportunities.

How MFN And IRP Convergence Are Rewriting Biotech’s Playbook

 
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Biotech’s pricing playbook is being upended as US Most-Favored Nation rules collide with Europe’s evolving International Reference Pricing models. The result: launch strategies, deal structures and innovation pipelines are all under pressure.


Podcast: Charles River CSO Calls For Collaboration On Non-Animal Models

 

Charles River’s CSO Julie Frearson outlines the FDA’s planned transition away from animal testing, changing attitudes to artificial intelligence, and the move to New Alternative Methods.

Trump II, Year One: Updated Version Seems Buggy For Pharma

 
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Issues that had been concerns in Trump’s first term are realities now, but industry has also seen some successes. Trump’s personalistic style of governance means that larger firms may be at an advantage because of their greater flexibility to cut deals on individual products.

Patient-Centric Strategy Drives Memo Therapeutics Forward

 

Memo Therapeutics is sharpening its focus on its lead antibody Potravitug, for BK polyomavirus (BKPyV) in kidney transplant patients as it prepares for Phase III trials and doubles down on patient engagement.

China’s Policies Prompt Reflection Among Global Medtechs As Local Players Adapt

 
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Chinese medtechs are expanding rapidly worldwide, but gaining market access within China itself – poised to become the world’s largest medtech market – is proving to be a very different challenge.


The Rise In China Deals: How International Biopharma Is Turning To China For Innovation

 

The rapid growth of Chinese biopharmas has led to increased dealmaking with the US and Europe, but that could be stifled by a potential new Trump Administration policy.

By The Numbers: Phase III Trials In China Skyrocket While Phase I Falls To Earth

 
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China has rapidly expanded its clinical trial footprint since 2015, driven by regulatory reforms and increased investment in pharma R&D. By 2023, it matched the US in trial volume. Oncology leads, but biologics are leading in momentum.

Navigating the GLP-1 Opportunity In China: Strategic Imperatives For Western Pharma

 
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The Chinese appetite for GLP-1s is noticeable. While the market opportunity for western pharma is huge, so are the strategic market access challenges, though not unsurmountable, L.E.K. Consulting told In Vivo.

Can Italy Shake Off Its Reputation And Become A Premier Hub For Biotech?

 
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Leading industry experts have spoken to In Vivo about how investment, a change in mindset and a fresh approach to policy may allow Italy to kick-start its biotech ecosystem.


Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
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Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Turning Defense Into Attack: Snapshots Of A Changing Medtech Market And How To Respond

 
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Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.

UK Bets On Regulatory Innovation As Competitive Advantage In Synthetic Biology

 
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The UK government has prioritized synthetic biology and created a "concierge service" for biotechs just as the US cuts science funding.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
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Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.