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...

Pharma Outsourcing – Find the Right Partner (2025)

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...

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.

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...

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Astra Zeneca’s asthma drug nears approval for sinus inflammation

Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.

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...

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.

A cluster contribution to European life science innovation and competitiveness?

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 ...

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...

He takes over the chairmanship of Karolinska Development

Ben Toogood is appointed as the new chairman of Karolinska Developments.

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.

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...

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...

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...

Pharma Outsourcing – Find the Right Partner (2026)

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...

Nobel Prize winner Torsten Wiesel turns 100: “Old men like me should use their experience to help the young”

In 1955, a young Torsten Wiesel jumped on a boat to the US and embarked on a fabulous career as a neuroscientist, crowned with a Nobel Prize for his work. Now 1...

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.