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...

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...

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Efter stökig process – nu godkänns Leqembi i Australien

Det svenskutvecklade alzheimerläkemedlet Leqembi har till slut godkänts i Australien, efter flera komplicerade turer.

ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA

ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

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...

Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...

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 mar...

Vectura värvar Britta Stenson från Business Sweden

Fastighetsbolaget Vectura har rekryterat Britta Stenson till en ny roll som Director Community Life Science.

Tre nya ansikten på KI Innovations

Företagsinkubatorn KI Innovations har anställt tre nya medarbetare med bred erfarenhet från life science-sektorn.

Vd-byte i Frost Pharma

Frost Pharma har utsett Magnus Nylén till ny vd.

Hallå där... Mattias Gäreskog, ny Life Science Lead på Business Sweden

Marie Gårdmark: “What to expect from Trump’s second term?”

One may complain about the complex multinational system in EU, but it gives us some predictability that cannot be easily overturned by different member states p...

Svensk life science växer – men kapitalet hänger inte med

Antalet anställda och antalet företag inom svensk life science ökar och sektorn är mer jämställd än många andra sektorer. Men investeringarna i onoterade bolag är svag.

AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential

AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce ...

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.

Ny rapport: Små bolag lyfter svensk läkemedelsutveckling

Sveriges läkemedelsforskning fortsätter att gå starkt framåt, enligt en ny rapport från Sweden Bio. Landets projekt blir både fler och vassare – med småbolagen i spetsen.

Tau-targeted Alzheimer's drug gets Fast Track designation in the USA

Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

Security flaw in Swedish breast cancer screening software – woman passed away

A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...

Quretech granted a European patent for a new type of antibiotic

The European patent provides protection until 2041. Previously, the patent was granted in China, and the application is currently under review in the USA, India, and Japan.

The business coach: “We need to learn from our mistakes”

The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...

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...