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...

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...

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

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...

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...

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.

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...

Life science-bolag pitchade idéer i eget ”Draknästet”

Ett nytt event, arrangerat av Medicon Village, lockade investerare att höra presentationer från life science- och medtechbolag. ”Det fördes diskussioner om intr...

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...

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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 ...

Will the FDA’s new transparency policy extend to medical devices? (Part 1)

In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...

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...

In-Depth Insights into the Most Useful ZEISS Metrology Expert Tips

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Pharma Outsourcing – Find the Right Partner (2025)

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...

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Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

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An organ seldom in the spotlight – but utterly vital

The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...

Discover ZEISS ZEN core – now for electron microscopy

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A tiny animal with great importance

From the mythical Ganges River to the less sacred, but considerably cleaner waters in KI's aquariums in Solna. The little zebrafish has made an unconscious care...

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it