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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...

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...

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...

A cluster contribution to European life science innovation and competitiveness?

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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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 ...

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...

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...

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...

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...

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...

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...

The art of successful licensing – “A lot has to align”

Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...

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.

Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field

Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. L...

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...

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

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...

Quality assurance for research and development of medical devices

Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.

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...

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.