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.

Mercks RSV-läkemedel får tummen upp i USA – tar upp kampen med Beyfortus

Amerikanska FDA godkänner Mercks nya läkemedel mot infektioner orsakade av RS-virus. Därmed får Sanofis och Astra Zenecas storsäljare Beyfortus ny konkurrens.

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Nordic Regulatory experts: Improving biotech chances of Succ

Why is it that so many biotech companies fail? And what are the tools needed to change that fact?

Come see us at the upcoming events!

We have some upcoming events where you can see our latest products live!

Ytterligare läkemedelskandidat mot Alzheimers droppas

Ett litet schweiziskt biotechbolag avbryter en fas II-studien med sin läkemedelskandidat mot Alzheimers sjukdom. Beskedet kommer inte långt efter att Biogen och...

Gothenburg, the city of life science – We are ‘Little Boston’

Western Sweden is investing in life science within everything from advanced therapeutic drugs to femtech. At the same time, stakeholders are looking to other in...

Björn Arvidsson: ”We need to change perspective”

If you say “life science” to a person on the street and ask them to explain what it is, you will probably get no good answer. The same question to your network ...

Orbán's extended arm becomes health commissioner in the EU

Hungarian Olivér Várhelyi may soon become the most influential official for the healthcare and pharmaceutical industry in the EU. Várhelyi, who is close to Hung...

Bio Europe to Stockholm – ”The Swedish ecosystem is now taking the opportunity”

The international life science conference Bio Europe is coming to Sweden for the first time in November. The conference, whose program takes inspiration from AB...

Ossiform: Quality control of 3D printed bone implants

Ossiform chose the GOM Scan 1.

Anna Törner: ”Mom, do you think you’ll ever get married again?”

”I realize I’m slowly descending into that familiar statistical rabbit hole, where life’s biggest uncertainties are reduced to point estimates and confidence in...

Isländskt läkemedelsbolag noterar sig på Stockholmsbörsen - ”Naturligt steg”

Ett av Islands största företag, läkemedelsbolaget Alvotech, planerar att notera sig på Nasdaq Stockholm.

Charlotta Gummeson leaves Sahlgrenska Science Park – “It feels sad and exciting at the same time”

With mixed emotions, Charlotta Gummeson will leave her position as CEO of Sahlgrenska Science Park in October. “It feels sad and exciting at the same time. I’ve...

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.

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 presents the "Quality Innovation Summit"

A global event on the future of quality assurance.

Storaffär inom CAR-T-terapier – Roche tar över amerikanskt bolag

Roche förvärvar amerikanska Poseida Therapeutics och stärker sin portfölj inom CAR-T-cellsterapier.

Webinar: Support Trial Patients Transitioning to the Commercial Space

Register for expert insights on supporting Phase III clinical trial patients post-approval and read our blog on advanced Patient Assistance Programs.

Uppgifter: Astra Zeneca överväger flytta börsnoteringen till USA

Astra Zenecas vd Pascal Soriot uppges vilja flytta bolagets huvudnotering från London till USA, rapporterar brittiska tidningen The Times.

The key to successful collaboration between industry and academia

Why is collaboration between industry and academia necessary in the life sciences sector? What obstacles exist, and what is the key to successful collaboration?

Studie: Uppväxtort kan påverka risk för typ 1-diabetes

Risken att utveckla diabetes typ 1 varierar kraftigt beroende på var i Sverige du har bott som barn, enligt en ny studie från Göteborgs universitet. Resultatet ...

Petter Hartman: ”Existentiell egenvård i en kaotisk värld”

”Vår förmåga att möta livets svårigheter tycks hänga ihop med känslan av gemenskap och meningsfullhet”, skriver Petter Hartman i en krönika som tar upp regering...

How to transport hydrogen - the BionicHydrogenBattery

Have you ever wondered how hydrogen should be transported and stored safely. Well, here is a solution for all who is interested in making a true infrastructure work.