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.

An easy way to handle microtiter plate stacks

Do you want to automate handling of microtiter plates.? Have a look at a very simple solution on how to handle them.

Sobi announces agreement with Enable Injections

Swedish biopharma Sobi has entered into an international development and distribution agreement with US drug delivery company Enable Injections.

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.

”The importance of stratification in a statistician’s August kitchen”

Ingrid Lönnstedt writes about an experiment of her own at home and about what lessons can be learned from it, in a science column.

The Future of Metrology is Coming to Your Region

Join our event series.

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.

Pneumatics Makes a Technological Leap with Piezo

The first high-precision proportional valve terminal VTEP opens up new application areas

Introducing ZEISS arivis Pro 4.2

Your solution for advanced image analysis and visualization.

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...

Danish biotech to buy struggling American oncology company

Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.

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.

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

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.

Billion-Dollar Deal Sends BioArctic Soaring

Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

Leo Pharma to cut 200 jobs and reorganize

Danish Leo Pharma cuts down on staff in its global operations. Around 200 positions will be cut, while 50 will be moved to Poland.

KI’s freezer fiasco investigated: A chain of failures

A chain of combined technical and organisational shortcomings caused the freezer breakdown at the Karolinska Institute during the Christmas holidays, destroying...

Ingrid Lönnstedt: Demystification of the power of a scientific study

”You surely do realize that even the smallest changes in study assumptions may influence the estimated sample size needed. And how is it even possible to guess ...

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...

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...

Standardisation in automation

B. Braun Melsungen had a great idea and implemented it throughout the plant. Production for infusion solutions was to be largely standardised. B. Braun hoped th...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

Editorial: ”AI that both impresses and frightens”

”In the past, I've rarely been particularly impressed by something that was produced by AI. But this is something completely different”, Samuel Lagercrantz writ...