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 fryser miljardinvestering i Storbritannien

Astra Zeneca har pausat en planerad investering på motsvarande 2,5 miljarder kronor. Det är det senaste läkemedelsbolaget som drar tillbaka sina satsningar i Storbritannien.

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.

Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

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. ...

Åsa Derolf lämnar NT-rådet för nytt chefsjobb

Åsa Rangert Derolf lämnar sitt tunga uppdrag som ordförande för NT-rådet. I stället blir hon en av två nya områdeschefer på Södersjukhuset i Stockholm.

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.

Enkelt test kan förutsäga leversjukdom - ”Bygger på tre enkla blodprover”

Ett blodtest, utvecklat av forskare vid Karolinska institutet, kan förutsäga risken att utveckla allvarlig leversjukdom, enligt en ny studie

New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential

AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce ...

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...

Sobi announces agreement with Enable Injections

Swedish biopharma Sobi has entered into an international development and distribution agreement with US drug delivery company Enable Injections.

Uppsalaanläggning tas över av nederländskt bolag

Uppsalabaserade OT Chemistry med 20-talet anställda förvärvas av det nederländska CDMO-bolaget Ofichem.

A cluster contribution to European life science innovation and competitiveness?

FDA plans to replace animal testing with AI – “Paradigm shift”

The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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...

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.

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

The FDA’s new transparency policy (Part 2)

increased transparency also serve to strengthen the likelihood of a successful submission.

GSK acquires oncology research company

GSK acquires the American biotechnology company Idrx for up to 1.15 billion dollars.