IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

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...

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...

“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...

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.

Discover ZEISS ZEN core – now for electron microscopy

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Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

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...

A cluster contribution to European life science innovation and competitiveness?

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...

Shaping the Future of Metrology – Live in Your Region

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Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...

FDA launches investigation into gene therapy following child death

The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...

Acne medication may be the solution when hair starts falling out

A treatment originally developed for acne has shown remarkable Phase III results in a completely different area: male-pattern hair loss.

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 ...

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New Insights into Microscopy

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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...

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

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...

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En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...

The Future of Metrology is Coming to Your Region

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