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...

Sneak Peek of ZEISS Metrology Expert Tips Season 2

The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.

Han tar över vd-posten på Läkemedelshandlarna

Branschföreningen Läkemedelshandlarna har fått en ny vd. I början av september tog Andreas Rosenlund över stafettpinnen från Fredrik Skepp.

New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

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...

Hon tar över vd-posten på Rise

Forskningsinstitutet Rise har utsett Malin Frenning till ny vd efter Pia Sandvik.

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...

Osäkerhet kring IVF-reform i USA – svenskt bolag backar

Vita huset backar från Donald Trumps vallöfte om att öka tillgången till fertilitetsbehandlingar. Svenskt medicinteknikbolaget faller ytterligare efter beskedet.

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...

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Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute

Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.

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...

Study: Vaccination linked to lower risk of post-COVID

The risk of developing post-COVID after a COVID infection was reduced in vaccinated people, according to a new study from the University of Gothenburg.

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...

Pharma Outsourcing – Find the Right Partner (2025)

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Cantargia utser Hilde Steineger till ny vd

Det Lundbaserade forskningsbolaget Cantargia har utsett Hilde Steineger till ny vd.

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...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

Han är ny vd för Läkemedelsförsäkringen

Svenska Läkemedelsförsäkringen har fått en ny vd. Juristen Anders Hultman tar över efter Robert Ström, som går i pension efter nio år på posten.