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.

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

Ukraine war fuels rise of totally resistent bacteria

War-torn Ukraine is not just suffering from hostile attacks from a foreign aggressor, but also from the threat of a totally resistant and contagious bacteria.

A cluster contribution to European life science innovation and competitiveness?

New cell therapy raises hope for curing type 1 diabetes – "Never succeeded before"

For the first time, a patient with type 1 diabetes has undergone an islet transplantation using genetically modified insulin-producing cells that do not require...

Sneak Peek of ZEISS Metrology Expert Tips Season 2

The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.

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...

Life science trends 2025 – The economy

Upcoming patent expirations are driving pharmaceutical companies to acquire in 2025. In Sweden, we may be on our way to brighter times and fewer bankruptcies. T...

Tiden på väg att löpa ut för Pfizer i budstrid

Pfizers misslyckas med att juridiskt försöka stoppa Novo Nordisks uppköp av bioteknikbolaget Metsera. Den amerikanska läkemedelsjätten har nu två dagar på sig a...

Källor: Novo och Lilly nära prisavtal med Vita huset

Amerikanska läkemedelsbolaget Eli Lilly och danska branschkollegan Novo Nordisk förbereder sig för att tillkännage nya prisavtal för läkemedel i en uppgörelse m...

Life science trends 2025 – Neurology

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-...

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...

How the Foreign Office will promote Swedish life science exports

The broadness and innovative strength keep Swedish life science exports strong, but the protectionist tendencies in the world are worrying, says Camilla Melland...

Cancer researcher: “We can do better and reduce suffering”

Lund University researcher Catharina Hagerling is developing innovative methods to understand metastatic cancer, aiming to create more targeted treatments for p...

Life science-bolag pitchade idéer i eget ”Draknästet”

Ett nytt event, arrangerat av Medicon Village, lockade investerare att höra presentationer från life science- och medtechbolag. ”Det fördes diskussioner om intr...

A new special edition and a new event in Copenhagen – This is happening at Life Science Sweden 2024

The new year brings new features for the readers of Life Science Sweden.

Several departures at the top at Nykode

Members of both the management and the board are leaving the Norwegian biotech company Nykode.

Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”

USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...

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Rise and Scantox cease conducting animal testing in Stockholm

Access to in vivo toxicology services is significantly decreasing in the Stockholm area as Rise shuts down animal testing and Scantox reorganizes. ”The costs ar...

Astra Zeneca faces potential multimillion-dollar fines in China

Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following ea...

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

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