Bio-Works

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...

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...

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...

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 ...

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.

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...

Acne medication may be the solution when hair starts falling out

A treatment originally developed for acne has shown remarkable Phase III results in a completely different area: male-pattern hair loss.

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.

New drug to simplify treatment of hemophilia

A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).

Nextcell Pharma rekryterar ny CFO inför internationell expansion

Biotechbolaget Nextcell Pharma har utsett Eric Gustafsson till ny finanschef (CFO). Han tillträder den 15 december.

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

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...

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 ...

Tummen upp för fördröjande behandling av typ 1-diabetes

En ny behandling för att bromsa insjuknandet i typ 1-diabetes rekommenderas för godkännande i EU.

Webinar: Can AI replace humans in pharmacovigilance?

The webinar will explore how AI can transform pharmacovigilance by enhancing efficiency, reducing errors, and addressing challenges such as software costs, data...

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

Health politician Lina Nordquist: ”I find it hard to be idle”

She is the pharmacist and researcher who grew tired of the breakthroughs that never materialised and knowledge that never seemed to reach patients, so she decid...

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...

Virology professor on the threat from X: ”The next pandemic could be worse“

The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...

Karolinska Development tar in kapital – och byter namn

Life science-investmentbolaget Karolinska Development föreslår en företrädesemission om cirka 203 miljoner kronor före transaktionskostnader.

Svenskt biotechbolag tar in 153 miljoner till cancerstudie

One-carbon Therapeutics, ett svenskt biotechbolag med inriktning på svårbehandlad cancer, har tagit in 153 miljoner kronor i en övertecknad investeringsrunda.

Lundbeck kliver in i budstrid om narkolepsibolag

En budstrid har brutit ut om det irländska biotechbolaget Avadel Pharmaceuticals och dess potentiella storsäljare inom narkolepsi och hypersomni.

New moves around Nykode's management – withdrawal of resignations

Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.