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.

Anna Törner: ”Varför inte slå till på en ADHD-diagnos till kampanjpris?”

”Det är självklart positivt att neuropsykiatriska diagnoser inte upplevs som stigmatiserande, men just när det gäller ADHD kan jag inte låta bli att undra om de...

The investor: “The major common diseases are hot again”

She has previously been voted Investor of the Year and will now be moderating The Future of Swedish & Danish Life Science congress. We check the temperature of ...

Anna Törner: ”If I fall seriously ill, I’ll move to Finland”

”It is both undignified and undemocratic that cancer patients must travel to Finland to uphold a façade of fairness that does not truly exist”, Anna Törner writes in a column.

Camurus får grönt ljus i EU för behandling mot akromegali

Lundabolaget Camurus behandling för hormonsjukdomen akromegali – eller jätteväxt – har fått ett positivt utlåtande av den europeiska läkemedelsmyndigheten EMA o...

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 ...

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)

Join the premier metrology and quality assurance event of the year

ZEISS QUALITY INNOVATION SUMMIT in Berlin, October 22-24, 2024.

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.

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...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

The fast route to a safe insulin pen

the pens using the Festo automation platform.

FDA godkänner genterapi för sällsynt sjukdom

FDA har godkänt PTC Therapeutics genterapi för att behandla en potentiellt dödlig enzymbrist. Genterapin har varit godkänd i EU sedan 2022 under namnet Upstaza.

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...

Sustainability at Festo

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

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...

Pneumatics Makes a Technological Leap with Piezo

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

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...

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...

Save the dates: ZEISS Quality Innovation Summit, October 22-24

Embark on a journey to the future of metrology.

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...

Explore the latest trends and innovations in quality assurance and manufacturing

ZEISS QUALITY INNOVATION SUMMIT in Berlin, October 22-24, 2024.

Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.