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...

FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy

FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...

Partial court victory for entrepreneur who lost his company

Swedish life science entrepreneur Mikael Kubista has won the first round against a law firm that he, along with other co-owners, sued for negligent advice in co...

A cluster contribution to European life science innovation and competitiveness?

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...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

Novartis storsatsar på RNA-terapier – köper miljardbolag

Novartis förvärvar amerikanska Avidity Biosciences för 12 miljarder dollar, motsvarande 113 miljarder kronor. Köpet stärker bolagets position inom sällsynta mus...

A new special edition and a new event in Copenhagen – This is happening at Life Science Sweden 2024

The new year brings new features for the readers of Life Science Sweden.

Clean solutions - Handling viscose substances with precision

Laboratories in the chemical, petrochemical, pharmaceutical and food technology industries are increasingly relying on automation for sample preparation. The Mo...

First preterm infants study – a vital step for Neola

After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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...

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

Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

Hypothesis testing versus conspiracy theory

"How do you know what is a conspiracy theory and what is a reasonable, scientifically based conclusion?" In a column, Ingrid Lönnstedt reflects on this question.

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...

Ukraine war fuels rise of totally resistent bacteria

War-torn Ukraine is not just suffering from hostile attacks from a foreign aggressor, but also from the threat of a totally resistant and contagious bacteria.

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

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...

ZEISS Connected Quality: One metrology hub

The new product family ZEISS CONNECTED QUALITY is the solution for quick and secure data exchange, quality management and efficient system monitoring.

Security flaw in Swedish breast cancer screening software – woman passed away

A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...

Improving Nano-Structured Surfaces for Implants with Scanning Electron Microscopy

Promimic, a Swedish company specializing in the development and marketing of nano-structured surfaces for implants, heavily relies on scanning electron microscopes.

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...