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.

JMP Statistical Discovery

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...

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...

Advancing Drug Discovery by Combining Complex In-Vitro Models with AI-Powered 3D/4D Image Analysis

Free webinar organized by ZEISS.

Introducing ZEISS arivis Pro 4.2

Your solution for advanced image analysis and visualization.

Automated nitrogen analysis reduces costs per sample

N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo

Scientific Solutions

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Copenhagen (2026)

The Top 10 Challenges Facing Laboratories Today

Navigating the Laboratory Automation Landscape

Optimera flödeshanteringen med Brooks Expert Support Tool (BEST)

Brooks Instrument erbjuder ett kraftfullt verktyg för dig som arbetar med digitala massflödesmätare och massflödesregulatorer. Med den Windows-baserade mjukvara...

How to Assure Quality within R&D Medical Devices

Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.

Orexo får USA-stöd för överdosläkemedel vid blandmissbruk

Uppsalabolaget Orexo har fått 8 miljoner dollar, motsvarande 75 miljoner kronor, av den amerikanska myndigheten Barda för att ta fram ett nasalt räddningsläkeme...

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...

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...

Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel

USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.

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...

Öresundsinstitutets vd: Novo Nordisk i aktiekris snarare än företagskris

Nedskärningarna på Novo Nordisk väcker frågor i hela den nordiska life science-sektorn. Men enligt Johan Wessman, vd för det dansk-svenska kunskapscentret Öresu...

Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...

Investors portföljbolag köper diagnostikföretag – för 22 miljarder kronor

Advanced Instruments har ingått ett bindande avtal om att förvärva Nova Biomedical för 2,2 miljarder dollar, motsvarande cirka 22 miljarder kronor.

Speed meets precision for high-density components

ZEISS METROTOM 800 320 kV.

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...