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Norway rejects national life science strategy – sees no need
The Norwegian Arbeiderpartiet rejects a proposal that Norway should develop its own life science strategy.
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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.
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A tiny animal with great importance
From the mythical Ganges River to the less sacred, but considerably cleaner waters in KI's aquariums in Solna. The little zebrafish has made an unconscious 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 importance of stratification in a statistician’s August kitchen”
Ingrid Lönnstedt writes about an experiment of her own at home and about what lessons can be learned from it, in a science column.
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ZEISS continues to drive digital era forward in ophthalmology
2 million digitally planned cataract cases in the U.S. alone.
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but later approved. While this “radical transparency” currently applies only to pharmaceuticals...
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First preterm infants study – a vital step for Neola
After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...
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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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Anna Törner: ”If I fall seriously ill, I’ll move to Finland”
”It is both undignified and undemocratic that cancer patients must travel to Finland to uphold a façade of fairness that does not truly exist”, Anna Törner writes in a column.
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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. ...
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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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Life science trends 2025 – The economy
Upcoming patent expirations are driving pharmaceutical companies to acquire in 2025. In Sweden, we may be on our way to brighter times and fewer bankruptcies. T...
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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...
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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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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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Astra Zeneca faces potential multimillion-dollar fines in China
Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following ea...
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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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How the Foreign Office will promote Swedish life science exports
The broadness and innovative strength keep Swedish life science exports strong, but the protectionist tendencies in the world are worrying, says Camilla Melland...
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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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Her company is developing a new tablet form obesity drug
Obesity and diabetes are the primary targets of a new tablet treatment under development by Malmö-based Pila Pharma. The company’s ambition is to take on the bi...
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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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Hann du läsa det här? Redaktionen tipsar
Missade du vår rapportering om rovtidsskrifter, rankningen av Sveriges främsta forskare eller reportaget från KI:s zebrafiskakvarium? Inför sommarens lata dagar...
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Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute
Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.
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