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.

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

Medivir CEO on upcoming study: ”It's about working together with others”

Medivir is a small company with a big task: to take its drug candidate, via extensive clinical studies, all the way to a patient group that currently lacks appr...

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...

Vaccinskeptiker ny ordförande för amerikansk covid-kommitté

Enligt professor Retsef Levi kan mRNA-vacciner orsaka allvarlig skada och död och bör därför omedelbart dras tillbaka. Nu har han utsetts till att leda arbetsgr...

Positive EMA Decision for BioArctic's New Drug Candidate

Bioarctic's drug candidate for multiple system atrophy, exidavnemab, is recommended to be classified as an orphan drug, according to the European Medicines Agency (EMA).

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...

Cantargia utser Hilde Steineger till ny vd

Det Lundbaserade forskningsbolaget Cantargia har utsett Hilde Steineger till ny vd.

Eternal Rye – Improving Plant Breeding Methods

User story from Martin Luther University Halle.

Cytel Inc acquires the SDS Group

The multinational statistical software developer and contract research organization Cytel Inc, headquartered in Massachusetts, USA, acquires the Swedish consult...

Takeover bid is being completed – Japanese company acquires Calliditas

Japanese company Asahi Kasei completes the bid for Calliditas Therapeutics after reaching over 90 percent of the shareholding. Callidita's board has now decided...

“Research is always a lot of failures and a few successes”

Gene therapies open up fantastic possibilities, but they are also extremely expensive to produce. Genenova aims to change that and make the treatments accessibl...

Discover Precision: Join ZEISS at the Control Fair in Stuttgart

May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.

Several departures at the top at Nykode

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

“Conducting research at universities is becoming more and more like working at a research hotel”

The government wants Swedish research to focus on excellence and innovation, but can the two be combined? Life Science Sweden talks to Anna Falk, a professor at...

Är ditt ERP redo att växa med ditt företag?

Att växa som företag handlar inte bara om fler kunder och högre försäljning – det innebär också att möta nya krav och utmaningar. Men vad händer när ditt affärs...

Improving Nano-Structured Surfaces for Implants with Scanning Electron Microscopy

Promimic, a Swedish company specializing in the development and marketing of nano-structured surfaces for implants, heavily relies on scanning electron microscopes.

RegSmart Life Science AB

Anna Törner: ”Orphan Designation – the "petite robe noire" of drug development”

It is easy to cling to various regulatory incentives, like orphan designation, and other expedited pathways, without understanding what they truly mean or wheth...

Xbrane tar in 240 miljoner – satsar vidare på biosimilarprojekt

Biosimilarutvecklaren Xbrane Biopharma tar in 240 miljoner kronor i en riktad nyemission, som var övertecknad.

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...

Mizarra Business Management

ZEISS supports the transition of spatial biology to clinical research

Slide scanner ZEISS Axioscan 7 spatial biology provides scalable workflow automation.

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 –...