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...

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...

Trump aviserar ny prispress – läkemedelsjättar faller

USA:s president Donald Trump har återigen riktat fokus mot landets läkemedelspriser. Han presenterar nu två separata initiativ för att pressa priserna på diabet...

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

Plug and play lösning för ångfällor

Spirax Sarco har en kompakt "allt-i-ett"-lösning när det kommer till installation av ångfällor. Den kompakta lösningen är optimal eftersom du kan installera kul...

A cluster contribution to European life science innovation and competitiveness?

Novo Nordisk appoints Mike Doustdar as new CEO

The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...

Lungforskningsbolag kan andas ut efter fulltecknad nyemission

Medicinteknikbolaget Pexa har beslutat att upprätta kontrollbalansräkning – men genomför också en fullt garanterad företrädesemission för att återupprätta sitt aktiekapital.

Inget statligt stöd för fetmaläkemedel – aktien för läkemedelsjättar pressas

Trump-administrationen slopar Bidens förslag om att om att inkludera fetmaläkemedel i sjukförsäkringen Medicare. Det innebär ett bakslag för Novo Nordisk och El...

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

Explore 3D Testing of Deformation and Motions

Powerful measurement capabilities with the new ZEISS ARAMIS 1.

New large lab building in Lund inaugurated – here are the companies moving in

Medicon Village has received a new laboratory building. On Friday last week the building was inaugurated with a ribbon-cutting ceremony by Minister for Employme...

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...

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.

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.

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...

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

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...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

GU Ventures AB

IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

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...

The Future of Metrology is Coming to Your Region

Join our event series.