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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...
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Tiden på väg att löpa ut för Pfizer i budstrid
Pfizers misslyckas med att juridiskt försöka stoppa Novo Nordisks uppköp av bioteknikbolaget Metsera. Den amerikanska läkemedelsjätten har nu två dagar på sig a...
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Källor: Novo och Lilly nära prisavtal med Vita huset
Amerikanska läkemedelsbolaget Eli Lilly och danska branschkollegan Novo Nordisk förbereder sig för att tillkännage nya prisavtal för läkemedel i en uppgörelse m...
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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.
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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.
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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.
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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...
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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...
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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...
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Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel
USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.
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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...
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Öresundsinstitutets vd: Novo Nordisk i aktiekris snarare än företagskris
Nedskärningarna på Novo Nordisk väcker frågor i hela den nordiska life science-sektorn. Men enligt Johan Wessman, vd för det dansk-svenska kunskapscentret Öresu...
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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 ...
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Abbvie förvärvar lovande projekt inom psykisk ohälsa
Abbvie köper ett läkemedelsprogram inom mental hälsa i en miljardaffär som ser lite annorlunda än vad som tidigare uppgetts.
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Abbvie ryktas överväga miljardförvärv inom mental hälsa
Läkemedelsbolaget Abbvie uppges föra diskussioner om att förvärva Gilgamesh Pharmaceuticals, ett bolag inom mental hälsa, i en affär som ska ligga på omkring en miljard dollar.
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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...
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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 ...
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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.
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Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”
USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...
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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).
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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...
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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.
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Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”
Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...
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