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...

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...

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...

GU Ventures AB

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...

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...

The Future of Swedish & Danish Life Science (2026)

Trump in new push to lower drug prices

U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...

Positivt USA-besked om Alzecures smärtpreparat

Alzecure har beviljats särläkemedelsstatus i USA för smärtpreparatet ACD440.

A cluster contribution to European life science innovation and competitiveness?

Egetis säkrar 183 miljoner i riktad nyemission

Genom en riktad nyemission på 183 miljoner kronor stärker Egetis Therapeutics sin finansiella position inför den planerade läkemedelsansökan i USA för särläkeme...

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 ...

Investigations against AstraZeneca: ”Chinese interests may be behind them”

Why are there several investigations against AstraZeneca employees in China right now? Life Science Sweden continues to seek answers.

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...

Karolinska ska bli ett europeiskt powerhouse för ATMP

Karolinska ATMP-centrum har ett enkelt men ambitiöst syfte: korta vägen mellan akademisk upptäckt och klinisk tillämpning. ”Vi önskar att Karolinska i framtiden...

Cost-efficient development of laboratory devices

8 ways to optimise development costs and speed up processes

We desire talent to come here, but are we genuinely welcoming them?

Sweden faces significant challenges in creating a truly inclusive environment that makes international professionals feel welcome, valued, and able to build mea...

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...

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...

Trumps order: Kräver lägre läkemedelspriser

USA:s hälsominister väntas inom 30 dagar sätta tydliga mål för lägre läkemedelspriser, med fokus på viktminskningsläkemedel. Det uppgav Vita huset under måndagen.

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...

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

Free webinar June 24th, 2025, 9:00-9:45 AM and 5:00-5:45 PM.

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

GBA Key2compliance rekryterar Camilla Oldgren till ny vd

Från och med den 1 juni är det Camilla Oldgren som leder konsultföretaget GBA Key2compliance.