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.

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.

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

GU Ventures AB

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

Investment CEO: “The Nordics are outstanding in creating successful medtech companies”

Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...

Explore the possibilities of the new ZEISS METROTOM 800 320 kV

Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.

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...

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...

Karolinska Developments portföljbolag Dilafor får USA-patent

Karolinska Developments portföljbolag Dilafor har beviljats patent i USA för sin läkemedelskandidat tafoxiparin. Patentet skyddar användningen av substansen vid...

Forskaren in Hagastaden now inagurated

The real estate company Vectura's life science center in Hagastaden, Forskaren, is now inaugurated. The opening was attended by people from the industry, politi...

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

Phase III win for Hansa Biopharma: “We Are Thrilled”

Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.

Pfizer stämmer Novo Nordisk i miljardstrid om biotechbolag

Budstriden om Metsera trappas upp när Pfizer stämmer både det amerikanska bioteknikbolaget och Novo Nordisk. Kärnfrågan är om Novos bud på 8,5 miljarder dollar ...

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

Nya life science-klustret – ”Vi är fantastiskt starka inom talang”

Målet för Stockholm och Uppsalas gemensamma life science-kluster är att tillhöra toppen i Europa. Enligt Pontus Holm, life science-koordinator för Region Stockh...

Del 4 i Advance serien: Produkter och system

Vi uppfyller dina specifika krav när standardlösningar inte räcker till.

ZEISS Lightfield 4D for instant volumetric high-speed imaging

Capturing physiological and neuronal processes in 3D.

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...

Hjärtövervakning vid bröstcancer sätts under lupp

Trastuzumab och efterföljande läkemedel har revolutionerat bröstcancervården och ökat överlevnaden markant. Men övervakningen av patienter för hjärtbiverkningar...

Lund University’s record-breaking recruitment – attracting researchers from around the world

The Swedish university is launching its largest international recruitment effort ever, aiming to hire 25 researchers globally, including several in the medical field.

UK Trade & Investment

The scientist behind Novo Nordisk's obesity success: “I never stopped believing in GLP-1”

It took several years of failures in GLP-1 before Lotte Bjerre Knudsen and her colleagues found the right path – but when they did, it was a true breakthrough. "We invested for 25 years while everyone else laughed at us. Now everyone wants to join...