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.

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...

Astra Zeneca faces potential multimillion-dollar fines in China

Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following ea...

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...

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...

Life science trends 2025 – The economy

Upcoming patent expirations are driving pharmaceutical companies to acquire in 2025. In Sweden, we may be on our way to brighter times and fewer bankruptcies. T...

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...

100 years of Festo

The spirit of invention is deeply rooted in our corporate culture. Since our foundation, we have been setting benchmarks by developing innovative solutions that...

Large study: The benefits and risks of obesity medications

Medications such as Ozempic can reduce the risk of a range of different diseases and health conditions but also increase the risk of others. This is according t...

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.

Mercodia AB

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...

Investment CEO: “The Nordics are outstanding in creating successful medtech companies”

Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...

GU Ventures AB

Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”

Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit

Explore our tailored program for Control 2025

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A new life science cluster formed – “We are very strong in talent”

Stockholm and Uppsala’s joint life science cluster aims to be among the best in Europe. Pontus Holm, Life Science Coordinator for Region Stockholm, says the dec...

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...

Stockholm and Uppsala jointly form a life science cluster

Stockholm and Uppsala are strengthening cooperation in medical research and biotech.

Rise and Scantox cease conducting animal testing in Stockholm

Access to in vivo toxicology services is significantly decreasing in the Stockholm area as Rise shuts down animal testing and Scantox reorganizes. ”The costs ar...

Sustainability at Festo

On the Way to the Net Zero Era - New Sustainability Report published

ZEISS Smartzoom 100 for Inspection Efficiency

Catch up on our free webinar.

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...

New moves around Nykode's management – withdrawal of resignations

Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.