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Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
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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...
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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...
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Grönt ljus för Gesyntas endometriosstudie i Storbritannien – ”Ett stort steg”
Gesynta Pharma har fått klartecken i Storbritannien för att inleda en fas II-studie med sin läkemedelskandidat inom endometrios.
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Charged with illegal pharmaceutical sales – alleged earnings of 23 million
For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Söder...
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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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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.
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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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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).
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FDA plans to replace animal testing with AI – “Paradigm shift”
The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met...
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The vaccine has saved 94 million lives – but measles is spreading again
A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...
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Trump in new push to lower drug prices
U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...
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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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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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Björn Arvidsson will lead research and innovation in Region Uppsala
The Swedish life science profile Björn Arvidsson has been appointed Director of Research and Innovation for Region Uppsala.
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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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FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy
FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...
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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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RegSmart Life Science AB
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Joy at Egetis after positive CHMP opinion – ”The single most important milestone”
Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."
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Marie Gårdmark: ”Interchangeable biological medicines – soon in a pharmacy near you?”
”Generic competition is an effective way to push down drug prices, but it has not worked equally well for biosimilars. Biosimilars require more time to gain mar...
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Lilly recruits top Swedish researcher in Alzheimer´s
One of Sweden's leading Alzheimer's researchers, Oskar Hansson, has been recruited by pharma giant Eli Lilly and will be moving to the USA.
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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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Lilly´s Nordic manager on Mounjaro launch in Sweden: "Patients deserve respect"
Another blockbuster diabetes and obesity drug has made its way into the Swedish market – with promises of a stable supply and availability for patients. “What w...