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.

Joy at Egetis after positive CHMP opinion – ”The single most important milestone”

Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."

Developing rapid diagnostics for sepsis – “Every hour counts”

Finding the right antibiotic in the right dose – with an ultra-fast analysis method. Gradientech's product solution is currently used in routine diagnostics at ...

Will the FDA’s new transparency policy extend to medical devices? (Part 1)

In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...

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...

Investigations against AstraZeneca: ”Chinese interests may be behind them”

Why are there several investigations against AstraZeneca employees in China right now? Life Science Sweden continues to seek answers.

Abbvie förvärvar lovande projekt inom psykisk ohälsa

Abbvie köper ett läkemedelsprogram inom mental hälsa i en miljardaffär som ser lite annorlunda än vad som tidigare uppgetts.

The US is leaving the WHO

The newly installed US President, Donald Trump, has issued an executive order for the US to leave the World Health Organization, WHO.

He takes over the chairmanship of Karolinska Development

Ben Toogood is appointed as the new chairman of Karolinska Developments.

Security flaw in Swedish breast cancer screening software – woman passed away

serious,” says the Sectra CEO to Medtech Magazine.

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.

Ranking: Top 10 highest-paid CEOs in pharma

It's nice to hear that things go well for others, right? Some of those who have done really well – at least financially – are listed here in the ranking of the best paid CEOs in Big Pharma 2023....

Explore 3D Testing of Deformation and Motions

Powerful measurement capabilities with the new ZEISS ARAMIS 1.

Xbrane enters licensing agreement with Indian generics giant

Swedish biosimilar developer Xbrane Biopharma and the Indian company Intas Pharmaceuticals have entered into a license and co-development agreement.

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...

Abbvie ryktas överväga miljardförvärv inom mental hälsa

Läkemedelsbolaget Abbvie uppges föra diskussioner om att förvärva Gilgamesh Pharmaceuticals, ett bolag inom mental hälsa, i en affär som ska ligga på omkring en miljard dollar.

Mercodia AB

Wegovy approved in the U.S. for treatment of liver disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...

Danish biotech to buy struggling American oncology company

Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.

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.

Roche’s Genentech terminates licencing deal with Norwegian biotech

Genentech is ending a license collaboration with Norwegian biotech Nykode Therapeutics regarding a clinical stage cancer vaccine program.

Thomas Eldered: ”Innovation is the key”

Thomas Eldered speaks in a web clip about the challenges facing the life science sector in the future and what he, as an investor, finds most interesting in new companies.

Drug development booms in Medicon Valley

When it comes to developing new medicines, the Öresund region is one of the top performers in the EU. Companies working on commission for pharmaceutical compani...

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.