A cluster contribution to European life science innovation and competitiveness?

“Access to capital increases when there’s an exit”

It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...

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 ...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

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.

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...

Shaping regulatory complexity into strategic clarity

As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...

Ledarskifte i GSK – Emma Walmsley lämnar efter åtta år

Läkemedelsjätten GSK:s vd Emma Walmsley lämnar efter åtta år på posten. Hon ersätts med Luke Miels, som idag är bolagets Chief Commercial Officer.

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

Scientific Solutions

Venomaid's rapid test aims to find the right snake bite treatment

Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom can help? Danish company Venomaid Diagnostics is working hard to develop solutions to a problem...

Ny smäll för Novo – backar efter miss i alzheimerstudie

Förväntningar om att Novo Nordisks GLP-1-läkemedel semaglutid skulle bromsa Alzheimers sjukdom infriades inte i sena kliniska studier.

Southern Swedish company Aqilion develops drug for eosinophilic esophagitis

When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...

Ny behandling mot narkolepsi på väg mot fas III

En ny läkemedelskandidat för narkolepsi visar lovande resultat i kliniska studier.

Wusson Accelerator AB

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

Cantargia rekryterar ny medicinsk chef

Bioteknikbolaget Cantargia har utsett Wolfram Dempke till ny Chief Medical Officer (CMO). Han tillträder rollen omedelbart och efterträder Morten Lind Jensen, s...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

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.

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Novartis storsatsar på RNA-terapier – köper miljardbolag

Novartis förvärvar amerikanska Avidity Biosciences för 12 miljarder dollar, motsvarande 113 miljarder kronor. Köpet stärker bolagets position inom sällsynta mus...

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...

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...

Bästsäljaren Keytruda blir enklare att ta – godkänns i subkutan form

MSD (känt som Merck i USA och Kanada) har fått klartecken från FDA och CHMP för en ny variant av sitt storsäljande cancerläkemedel Keytruda. Den nya versionen, ...