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...

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 15 major markets — one more than its closest rival, Eli Lilly’s Kisunla....

Mercodia AB

Kanceras vd avgår efter tuff tid för företaget

Peter Selin lämnar rollen som vd för Kancera, som byter namn till Novakand Pharma.

GU Ventures AB

ZEISS showcases expansion of ophthalmic care options creating industry-leading workflow solutions

ZEISS Medical Technology will showcase new ophthalmic innovations and market milestones at ESCRS 2025 in Copenhagen.

Strategic Clarity: The New Currency in Life Science

In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...

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...

Kancera vill undvika likvidation – söker omvänt förvärv

Forskningsbolaget Kancera är i ekonomiska svårigheter och söker intressenter för ett omvänt förvärv – ett alternativ som vägs mot likvidation av bolaget.

SGS Fimko beviljas status som anmält organ enligt IVD-förordningen

Helsingfors, 21.10.2025 / SGS Fimko Oy har nått en betydande milstolpe i och med att den Europeiska kommissionen officiellt har utsett företaget till ett anmält...

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 –...

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. ...

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 ...

The race between new alzheimer’s drugs Kisunla and Leqembi heats up

Kisunla or Leqembi? The rivalry between Eli Lilly and Bioarctic is intensifying. Where one drug gains approval, the other falls behind. Here's a look at the markets where these competing treatments are currently available....

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

Billion-Dollar Deal Sends BioArctic Soaring

Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...

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).

Positive trend for Swedish medtech exports – “We have new markets that are huge”

In 2024, Swedish exports of pharmaceuticals decreased for the first time in several years. However, the trend for medical technology looks brighter. During a se...

The top five most expensive drugs in 2025

New advanced therapeutic medicines are reaching the market, but their price tags remain exceptionally high. This year’s ranking of the most expensive drugs in t...

Karolinska Development kliver ur portföljbolaget Ossdsign

Investmentbolaget Karolinska Development avyttrar resterande aktier i portföljbolaget Ossdsign, som är verksamma inom benregenering.

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

A cluster contribution to European life science innovation and competitiveness?

Mångmiljonböter för diagnostikbolag – vilseledde marknaden

Magnasense, tidigare Aegirbio, ska betala 12 miljoner kronor i sanktionsavgift. Det slår Finansinspektionen fast, efter en granskning som visar att bolaget uppr...

Science to Market - S2M