A cluster contribution to European life science innovation and competitiveness?

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.

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.

Discover ZEISS ZEN core – now for electron microscopy

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Svensk obesitaskandidat visade lovande resultat – ”Kan få stor betydelse”

Tabletten ska främja viktminskning utan att påverka aptit eller muskelmassa. Resultaten är lovande, enligt en klinisk fas I-studie från Karolinska institutet oc...

The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

Kennedy-rådgivare vill stoppa kombovaccin för barn under fyra

Barnvaccineringen i USA är under omprövning. På torsdagen beslutade CDC:s rådgivande vaccinkommitté (ACIP) att stoppa användningen av ett av landets viktigaste ...

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...

The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

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. ...

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...

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

AstraZeneca to use American AI platform for cancer trials

In a collaboration AstraZeneca will use an AI model from Israeli-American biotech Immunai to streamline its clinical trials in cancer.

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.

Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel

USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.

Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”

Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit

How the Nobel discovery is used in drug development

Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...

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.

Doge backar om nedläggning av viktigt FDA-labb

Trumpadministrationen drar efter kritik tillbaka beslutet att stänga ett av FDA:s viktigaste laboratorier för läkemedelskontroll.

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.

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...

De får medicinpriset för upptäckt av immuntolerans

Året Nobelpris i fysiologi eller medicin tilldelas Mary Brunkow, Fred Ramsdell och Shimon Sakaguchi.