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.

She is CSL Behring's new Nordic General Manager

Since the beginning of january, Helena Bragd is the new Nordic General Manager for the biotech company CSL Behring and CEO of CSL Behring AB.

Moderna develops mRNA vaccine against norovirus

A highly anticipated vaccine is in late clinical evaluation and could be ready for approval within a couple of years. The target is the norovirus, often called ...

FDA approves new cystic fibrosis therapy

A new treatment for cystic fibrosis has been approved by the U.S. Food and Drug Administration (FDA).

Life science trends 2025 – Part 1 obesity drugs

More obesity drugs are being launched this year following Novo Nordisk and Eli Lilly's previous successes with GLP-1 drugs. But the next big breakthrough in obesity has a different mechanism of action, writes Samuel Lagercrantz in the first article...

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.

New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Stockholm (2025)

Karolinska ska bli ett europeiskt powerhouse för ATMP

Karolinska ATMP-centrum har ett enkelt men ambitiöst syfte: korta vägen mellan akademisk upptäckt och klinisk tillämpning. ”Vi önskar att Karolinska i framtiden...

Large study: The benefits and risks of obesity medications

Medications such as Ozempic can reduce the risk of a range of different diseases and health conditions but also increase the risk of others. This is according t...

Björn Arvidsson: ”We must raise our gaze to find the answers of the future”

A system approach isn't just about understanding complexity – it's about making better decisions. By seeing ourselves as part of larger systems, we can better a...

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

Government apoints new experts to medicine and health council

Johanna Fälting, Head of Research at BioArctic, and physician Markus Lingman have been appointed as new members of the Swedish Research Council’s Subject Counci...

ZEISS unveils AI-powered Research Data Platform

Collaboration with Boehringer Ingelheim champions the future of personalized eye care.

Novo Nordisk establishes new factory in Denmark

Novo Nordisk establishes a new production facility in Odense, Denmark, an investment of 8.5 billion Danish kroner.

The business coach: “We need to learn from our mistakes”

The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...

Icelandic pharmaceutical company Alvotech to list on Nasdaq Stockholm

One of Iceland's largest companies, the pharmaceutical firm Alvotech, has announced its intention to list on Nasdaq Stockholm.

Merck KGaA acquires American company in €3.0 billion deal

Germany’s Merck is completing the acquisition of Springwork Therapeutics for 3 billion euros.

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

Success for Genmab's antibody-drug conjugate

The Danish company Genmab has received Japanese approval for its treatment for advanced or recurrent cervical cancer.

A new life science cluster formed – “We are very strong in talent”

Stockholm and Uppsala’s joint life science cluster aims to be among the best in Europe. Pontus Holm, Life Science Coordinator for Region Stockholm, says the dec...

An increasing number of people are falling ill with TBE – “Much more research is needed”

Tick-borne meningitis, or TBE, is an increasingly common disease in Sweden. Currently, there is a vaccine against the disease but no drugs. Researcher Anna Över...

Thumbs down for lecanemab in the EU – “Very surprised”

The Azheimer's drug lecanemab has received a negative assessment from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), acc...

Speed meets precision for high-density components

ZEISS METROTOM 800 320 kV.

From lab to patient – the art of developing new antibody therapies

For 25 years, Danish company Genmab has been developing antibodies and has managed to get several drugs all the way to the patient. Esther Breij has been along ...