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...

A cluster contribution to European life science innovation and competitiveness?

TFS Trial Form Support AB

Nytt samarbete: Chat GPT flyttar in i Lundbecks laboratorier

Den danska läkemedelskoncernen Lundbeck tar hjälp av Open AI för att påskynda forskning och effektivisera arbetet inom hela verksamheten.

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...

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 ...

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.

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...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

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...

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...

Scientific Solutions

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 race between new alzheimer’s drugs Kisunla and Leqembi heats up

Kisunla or Leqembi? The rivalry between Eli Lilly and Bioarctic is intensifying. Where one drug gains approval, the other falls behind. Here's a look at the mar...

GU Ventures AB

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...

Strategic Clarity: The New Currency in Life Science

In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, expert support is no longer a luxury—it’s a strategic necessity....

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

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