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...

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 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...

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...

US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee

Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...

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...

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...

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...

Alzinova får FDA:s snabbspår för sitt alzheimervaccin

Biofarmabolaget Alzinovas vaccinkandidat mot Alzheimers sjukdom har beviljar Fast Track-status av USA:s läkemedelsmyndighet FDA.

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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Wegovy approved in the U.S. for treatment of liver disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...

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...

Charged with illegal pharmaceutical sales – alleged earnings of 23 million

For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Söder...

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...

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...

Plug and play lösning för ångfällor

Spirax Sarco har en kompakt "allt-i-ett"-lösning när det kommer till installation av ångfällor. Den kompakta lösningen är optimal eftersom du kan installera kul...

Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.

A cluster contribution to European life science innovation and competitiveness?

Introducing ZEISS arivis Pro 4.2

ZEISS arivis software enhances custom microscopy image analysis.

Roche’s Genentech terminates licencing deal with Norwegian biotech

Genentech is ending a license collaboration with Norwegian biotech Nykode Therapeutics regarding a clinical stage cancer vaccine program.

Alzinova tar steg mot fas II-studie i USA

Biofarmabolaget Alzinova hoppas kunna inleda en fas II-studie med sin vaccinkandidat mot Alzheimers under andra halvåret 2025.

Cost-efficient development of laboratory devices

8 ways to optimise development costs and speed up processes

CT technology for when the inside matters

ZEISS METROTOM 1 now at #HandsOnMetrology.