PMS, Vigilance and Risk Management

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...

”Trickier than bacteria”: Why severe fungal infections are on the rise

There’s a reason Earth is sometimes called the planet of fungi. These ancient organisms – billions of years old and more closely related to animals than to plan...

How the Nobel discovery is used in drug development

Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...

“Access to capital increases when there’s an exit”

It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...

Shaping regulatory complexity into strategic clarity

As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

Southern Swedish company Aqilion develops drug for eosinophilic esophagitis

When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...

Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

A cluster contribution to European life science innovation and competitiveness?

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

The FDA’s new transparency policy (Part 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...